A person holding a vial of insulin

“If I’m Out of Insulin, I’m Going to Die”

United States’ Lack of Regulation Fuels Crisis of Unaffordable Insulin

Zoe Witt, a type 1 diabetic in Seattle, Washington, holds a 10-milliliter vial of Novolog, a name-brand insulin analog produced by the Danish company Novo Nordisk. © 2022 Bella Petro

Summary

In the United States, access to lifesaving medication is a privilege that many cannot afford. Soaring medicine prices and inadequate health insurance coverage can result in unaffordable out-of-pocket costs that undermine the right to health, drive people into financial distress and debt, and disproportionately impact people who are socially and economically marginalized, reinforcing existing forms of structural discrimination.

“We almost lost my sister,” Sa’Ra Skipper, 25, of Indianapolis, Indiana, told Human Rights Watch in June 2021. “That was a really tough time, to see my sister lying in a hospital bed because she was just trying to help me out ... she kept me alive.”

In 2018, Skipper was working a job with health insurance that did not cover the insulin she needed, leaving her with monthly out-of-pocket costs of about $1,000. “How is somebody supposed to afford that?” she asked. “I wasn’t able to.”

At the time, Skipper’s sister, who also has diabetes, worked a lower-paying job and received free insulin from Medicaid, the US public health insurance program for people with low income. “[She] was giving me insulin,” Skipper explained. “We were sharing insulin out of the same vial ... I felt like I was taking from her.... But the system [didn’t] give me any other choice but to make me live this way.”

One night, Skipper took her nighttime dose of insulin and left the vial on the dresser for her sister to see. But her sister, unsure of whether Skipper had taken hers, took less than her normal dose to make sure that there was enough left. The next day, Skipper’s sister went into diabetic ketoacidosis, a potentially lethal complication of high blood sugar, and had to be hospitalized for four days. “She almost went into a diabetic coma.”

“They know that people are dying, that people can’t afford this,” Skipper told Human Rights Watch, speaking about the companies that manufacture the analog insulins upon which she and her sister depend.

As Skipper’s story shows, people with chronic health conditions who depend on life-saving medication, such as many people with diabetes, are especially vulnerable to the human rights impacts of unaffordable medicine. As part of ongoing research into growing healthcare costs, medical debt, and abusive debt collection practices in the US, this report uses diabetes and access to insulin to describe how US authorities’ regulatory failures have allowed for a crisis of unaffordable drug prices.

“We see people who pass away because they ration their insulin. We have cases where we see people who have an urgent need, and it was late, and they passed away.” — Allie Marotta © 2022 Private

As of 2018, nearly 27 million adults in the US have been diagnosed with diabetes, and approximately 8.2 million adults use one or more formulations of insulin to regulate their blood sugar. Without it, people who require insulin may experience high blood sugar, or hyperglycemia, which can lead to serious and even life-threatening complications.

Left unchecked, high blood sugar can kill. In the US, diabetes is the seventh leading cause of death and is the leading cause of renal failure, lower limb amputation, and blindness among adults. Diabetes increases risk of mortality from infections, cardiovascular disease, stroke, chronic kidney disease, chronic liver disease, Covid-19, and cancer, and has the second biggest negative total effect on reducing health-adjusted life expectancy worldwide.

Before the technique for extracting insulin from an animal’s pancreas was discovered in 1921, children with diabetes rarely survived longer than a year after their diagnosis. Over the years, pharmaceutical manufacturers have produced insulin and found ways to improve its effectiveness as a tool for the treatment of diabetes.

But in the US, the most commonly prescribed forms of this lifesaving drug can cost a person more than $300 for a single vial, easily adding up to more than $1,000 a month if they do not have adequate health insurance coverage. As the experiences documented in this report show, the high cost of insulin in the US is not just paid in dollars, but with health, lives, and livelihoods.

The cost of insulin—what an individual must pay to acquire it—is a result of two factors: (i) the price for the drug, and (ii) the degree to which that price is lessened, whether by insurance, charitable assistance, or other forms of cost mitigation.

Based on interviews with 31 people with chronic health conditions about their experiences with the healthcare system, including 18 who have insulin-dependent diabetes, this report focuses on the first factor—the cost of the drug. Drawing from interviews with people who require insulin and experts, extensive data analyses, and secondary literature review, this report describes the human rights impacts of policies that allow drug manufacturers and pharmacies to sell this life-saving medication at unaffordable prices. Forthcoming research will explore the second factor, drawing from interviews with people with chronic health conditions to describe how profound flaws in the health insurance system in the US undermine access to life-saving health care and contribute to the destructive medical debt that affects millions.

The high price of insulin has drawn increased scrutiny of insulin manufacturers’ practices by advocates, lawmakers, and law enforcement officials in recent years. Less discussed, however, has been how the lack of federal regulation has allowed this to occur. As the US Congress considers potential reforms to the system of drug pricing in the US, this report outlines the necessary components of a rights-respecting, drug price-setting system and explores the catastrophic costs of inaction, highlighting the profound impacts of high insulin prices on the lives and human rights of people who require insulin.

The Human Cost of High Analog Insulin Prices

Human Rights Watch conducted price analyses of three of the most widely used insulin analogs: Humalog, Novolog, and Lantus. Each of these drugs is produced by one of the three multinational pharmaceutical manufacturers that collectively dominate the global market for insulin, respectively: the US-based company, Eli Lilly; the Danish company, Novo Nordisk; and the French company, Sanofi.

In the US, the prices these manufacturers have set for these drugs—so-called list prices—have soared since their introduction to the market in the late 1990s and early 2000s.

Human Rights Watch analyzed publicly available price information and found that, when adjusted for inflation, Eli Lilly’s list price for Humalog increased by about 680 percent, to $275 per vial in 2018, since it first began selling in the US in 1996. The inflation-adjusted list price for Novo Nordisk’s Novolog rose about 403 percent, to about $289 per vial, between its market entry in 2000 and 2018. Similarly, Sanofi’s list price for Lantus rose about 420 percent when adjusted for inflation since its US market entry in 2000, to about $276 per vial in 2019.

“There were time periods where I needed to buy insulin but at that point your insurance is not kicking into effect, so you are paying the cash price for your insulin.” — Randall Barker © 2022 Private

In recent years, these rapid list price increases have slowed or ceased, in a context of increased scrutiny by policymakers, patients, advocates, and the media. But Human Rights Watch found that these still-high list prices have driven up out-of-pocket costs and have adversely impacted the lives of people who require insulin, especially those lacking access to effective cost-mitigation through health insurance or charitable aid.

Almost every insulin-dependent person Human Rights Watch interviewed said they had rationed analog insulin because of out-of-pocket costs, taking it in ways not recommended by their physician in order to stretch their supply. As Skipper’s story and others in this report show, insulin rationing can have damaging and potentially deadly consequences.

High out-of-pocket costs for essential medicines like analog insulin have an inherently regressive impact. All other factors being equal, people with less wealth must pay a much higher share of their income to satisfy equal medicinal needs than wealthier people. In turn, this disproportionate impact can negatively affect the standard of living for people who require insulin, as the money needed to acquire this lifesaving medicine can come at the expense of food, rent, and secure living conditions.

But even people with incomes that do not place them among the lowest paid workers in the country can find themselves unable to afford this lifesaving medicine.

Some of the most economically vulnerable people in the US may qualify for Medicaid, the income-based public health insurance program, or private charitable assistance programs, such as those funded by insulin manufacturers. However, income-based eligibility requirements for these programs can exclude low-income people who may earn too much to qualify, but not enough to afford, private health insurance or the cost of their medicines.

To qualify for Medicaid in 2021, a single person without dependents would need to earn below $17,774 in most states. But in the 12 states that have not adopted the 2010 Affordable Care Act so-called Medicaid expansion, no single-person households without dependents are eligible for this crucial safety net program. More than 2 million uninsured adults fall into this coverage gap nationwide, which disproportionately impacts Black, Indigenous, and other communities of color.

Communities and individuals marginalized from social, political, and economic power in the US are disproportionately impacted both by diabetes and its negative health outcomes. For example, according to 2016 data from the Centers for Disease Control and Prevention, about 356 people with diabetes underwent a lower-limb amputation every day in the US. Black adults in the US, however, were more than twice as likely to experience a diabetes-related amputation than white adults.

Similarly, a 2017 Yale Diabetes Center survey of 199 people with either type 1 or type 2 diabetes in Connecticut found that one-in-five white respondents rationed insulin in the past year, but were 18 percent less likely to ration insulin than the average. Both Latino/Hispanic and Black respondents, however, were more likely to ration insulin than the average, respectively about 10 and 22 percent more likely.

For many people, charitable initiatives funded by insulin manufacturers are a last line of defense against the high costs of these manufacturers’ products. But eligibility for their programs is limited, typically to US citizens or permanent residents who lack health insurance coverage for medications and have a household income at or below 400 percent of the Federal Poverty Level, or about $51,000 for a single individual.

While these manufacturer-funded initiatives can help lessen the burden of these manufacturers’ high insulin prices for some individuals, they do not present a universal nor sustainable model for addressing cost-related access issues and have clearly fallen short of preventing widespread insulin rationing because of cost.

Additionally, public and private financial assistance programs often restrict aid to US citizens or permanent residents, excluding both documented and undocumented immigrants, many of whom come from communities where diabetes is especially prevalent. Undocumented immigrants are already more than four times more likely to be uninsured than US citizens and are accordingly especially vulnerable to the harmful human rights impact of unaffordable insulin prices.

People who require lifesaving medicines like insulin will pay what they must to survive, regardless of its price. Or, as some of the experiences described in this report show, they will pay for as much as they can afford and hope not to die.

Causes of High Insulin Prices

The drivers of the high prices for analog insulin in the US are clear. Since the 1984 Drug Price Competition and Patent Term Restoration Act, which established the modern system of federal drug regulations, pharmaceutical innovation and access in the US have relied on the premise that innovative drugs are rewarded with high prices during their window of patent protection, with generic competition quickly reducing prices thereafter.

In contrast to most other countries, the US does not directly regulate drug prices. There are no regulations in place that define a fair price for medicines before they enter the market or restrict how much manufacturers or intermediaries can increase their prices once they do.

Numerous studies have found that the US is an outlier regarding per capita spending on prescription drugs when compared with other high- and middle-income countries. For example, the US House of Representatives Ways and Means Committee analyzed international drug price data from 2017 and 2018 and found that insulin averaged $34.75 per dose in the US, compared to an average of $10.58 per dose in 11 other high-income countries. According to this study, Humalog’s price was 294 percent higher per dose in the US than the international average, Novolog’s was more than 320 percent higher, and Lantus’ was 75 percent higher.

Although unregulated pricing practices allow drug manufacturers to set very high prices, pharmaceutical manufacturers are not the sole drivers of unaffordability. A complicated web of intermediaries in the supply chain between a drug’s manufacturer and purchaser contribute to the cost that individuals with insulin needs must bear to access their essential medicine.

“As long as your healthcare system is like this and as long as there isn’t a federal list price cap on analog insulin, the only people who benefit are the pharma companies.” — Zoe Witt. © 2022 Bella Petro

In particular, the opaque system of rebates from drug manufacturers to pharmacy benefit managers (PBM), powerful gatekeepers to health insurance companies’ drug formularies, appears to have created an upward pressure on insulin prices in past years. Manufacturers can lose access to large shares of the US market if their drug is excluded from or given restricted placement on these drug formularies, which service millions of people covered by health insurance plans. As a result, manufacturers of similar types of drugs, such as analog insulin, have competed to ensure that PBMs give their products beneficial placement.

But this competition is done through a largely unseen system of rebates: a negotiated cash payment, calculated as a percentage of the drug’s list price, made by drug manufacturers to the PBMs and the health plans they represent for purchase of their product. This rebate system has allowed insulin manufacturers to compete over the years without sacrificing revenue or lowering the list price of medicines. To offer more generous rebates than their competitors without impacting their bottom line, manufacturers can simply increase the list price for their products.

Some people with health insurance may have never noticed the rapid list price increases documented in this report. But people without insurance or with inadequate insurance, who are much more likely to be from marginalized communities and working low-income jobs, may have had no choice but to bear the burden of their medicine’s ever-increasing cost.

Seen together, this system creates a sequence of regressive subsidies. First, the absence of drug pricing regulations in the US allows insulin manufacturers to price their products far above what is allowed in peer-income countries. Second, within the US, the system of rebates effectively forces many economically vulnerable under- and uninsured people, who do not benefit from any potential discounts stemming from rebates, to subsidize both drug manufacturers’ revenues and other people’s insurance premiums.

Government and Corporate Human Rights Responsibilities

Unregulated pharmaceutical pricing in the US and market practices that incentivize price increases can result in out-of-pocket costs for essential medicines that are so expensive as to undermine their equal and affordable access, a cornerstone of the human right to health. This dynamic disproportionately impacts people based on their economic status and within that group further disadvantages particular racial and ethnic groups in violation of domestic and international law prohibiting discrimination.

The Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights (ICESCR), which the US has signed but not ratified, affirm that governments are obligated to ensure that health care, including the provision of essential drugs as determined by the World Health Organization, is accessible to everyone without discrimination and affordable for all. This duty extends to preventing and protecting against human rights harms caused by businesses and other non-state actors, and may include or require effective regulation of their activities.

“I have rationed insulin before, even with insurance … because of a clerical error, I couldn't afford the out-of-pocket and I was fully employed with "good" insurance.” — Emily Miller. © 2022 Private

The International Covenant on Civil and Political Rights (ICCPR), which the US has ratified, and the ICESCR prohibit discrimination based on race, property or other status. The International Convention on the Elimination of All Forms of Racial Discrimination (ICERD), which the US has ratified, also includes specific prohibitions on discrimination based on race, ethnicity, and national origin, among other statuses. Under the ICERD, governments are obligated to act affirmatively to prevent or end policies with unjustified discriminatory racial impacts or effects.

Additionally, the Convention on the Rights of Persons with Disabilities (CRPD), which the US has signed but not ratified, both affirms the right to health for people with disabilities and obligates states to provide health services to people with disabilities to minimize and prevent the development of further disabilities. As described in this report, widespread cost-based insulin rationing can contribute to the development of long-term disabilities, such as blindness.

The continued failure of the US government to implement policies to prevent the price increases documented in this report, combined with its failure to take other necessary steps to mitigate healthcare costs, undermines equal and affordable access to insulin analogs, contributes to cost-based medicine rationing, contravenes the right to health, and may be inconsistent with its obligations as a signatory to the ICESCR and CRPD to refrain from acts that would defeat these treaties’ object and purpose.

Companies also have a responsibility under the United Nations Guiding Principles on Business and Human Rights to respect human rights and ensure that their practices do not cause or contribute to human rights abuses. Fundamental to this responsibility is the requirement that companies carry out human rights due diligence to identify the possible, and actual, human rights effects of their operations and establish meaningful processes to prevent, mitigate, and remediate harm when it occurs.

This responsibility extends to all actors in the supply chain between drug manufacturers and consumers, which should address policies and practices that contribute to out-of-pocket costs for insulin that undermine equal and affordable access to the drug.

The Way Forward

The US Congress should enact federal legislation to ensure that essential medications like insulin are, in practice, affordable to all people in the United States who need it, regardless of insurance, wealth, or citizenship status.

Congress should consider legislation to provide insulin to all insulin-dependent individuals in the country free-of-cost. But in the absence of such legislation, and given the inevitability of coverage gaps in existing health insurance systems, Congress should consider legislation to lower and regulate the prices for essential medications like insulin to levels that ensure affordable access and eliminate the de facto discriminatory impacts of drug prices on marginalized groups in the country.

Specifically, in consultation with key stakeholders, the US Congress should draft and enact legislation addressing the many profound flaws with the drug pricing system described in this report, including, among other things: establishing a consultative system to define the fair price for a drug before it enters the market; limiting how much manufacturers and intermediaries can increase the prices of their drugs after drugs enter the market; limiting the price-increasing influence of common industry practices like rebates and discounts; reforming the pharmaceutical patent system to limit abuse and provide for greater access to generics; and increasing transparency throughout the sector.

Federal departments, including the Department of Health and Human Services and Department of Commerce, and relevant agencies, such as the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and the Patent and Trademark Office, should also implement policies that will help lower prices for lifesaving medications like insulin to levels that ensure their affordable access.

“We are the wealthiest country in the world, but people have to go without medication,” said 29-year-old Emily Grant of Dallas, Texas, discussing the cost of her insulin. “[T]here’s nothing I can do about the trajectory of my illness except follow the treatment plans my doctors tell me. And I don’t think it’s okay to say, ‘Oh well, you either afford it or you die.’”

Glossary

Analog Insulin

A type of insulin that is genetically modified to alter its function within the body and more closely mimic insulin produced by the pancreas.

Authorized Generics

A non-branded version of a branded drug, produced by the same manufacturer as the branded drug.

Biologic

A type of drug composed of generally large, complex molecules that is often produced within a living organism or contains components of living organisms.

Biosimilar

A biologic drug that is highly similar to and has no clinically meaningful differences from an existing branded biologic drug approved by the FDA. Biosimilars are similar to generics but may require additional regulatory approval to be considered interchangeable with a branded biologic.

Copay

A payment made by a patient with health insurance at the point of sale for a covered service, usually a percentage of the overall cost, as defined by the terms of their health plan.

Deductible

A specific amount that an insured individual must pay out of pocket towards a specific service before their health insurance provider will begin to provide coverage for that service.

Diabetes

A chronic health condition that affects how the body produces or responds to the hormone insulin, resulting in abnormal metabolism of carbohydrates and elevated levels of glucose in the blood and urine.

FDA

The Food and Drug Administration, a federal agency of the US government that, among other things, regulates the safety and quality of food and medicines in the United States.

Follow-on

A copy of a branded, FDA-approved biologic drug produced by a different manufacturer. If a follow-on version of a biologic drug meets additional requirements, it can become a biosimilar. If a biosimilar meets additional requirements, it can be deemed interchangeable with the original, branded biologic drug.

Formulary

A list of medicines covered under a health insurance plan, often grouped into tiers that define different levels of cost-sharing.

Generics

A medication created to be the same as an already-marketed, branded drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

Insulin

A hormone produced within the pancreas of mammals that facilitates the transfer of glucose from the bloodstream into cells. This process is disrupted for people with diabetes, whose bodies may not produce or be resistant to the effects of insulin.

Interchangeable

A drug that is eligible under FDA regulations to be substituted by a pharmacist for its name brand version without the need for a different prescription, much like how generic drugs are routinely substituted for brand name drugs. This kind of pharmacy-level substitution is subject to state pharmacy laws.

List Price

The price manufacturers set for their medicine, also sometimes called the wholesale acquisition cost.

Net Price

The actual amount that a drug manufacturer receives from the downstream sale of a product they have made.

Rebate

A discount paid to the health insurance company from a manufacturer after the patient has received their medication.

Retail Price

The price for a drug from a pharmacy if someone pays out of pocket, without any form of cost mitigation, like coupons, discounts, health insurance, or other payment assistance.

Synthetic Insulin

Human insulin manufactured by inserting the insulin gene into bacteria, which are then farmed and harvested.

Type 1 Diabetes

An auto-immune, chronic condition in which the pancreas no longer produces any or sufficient insulin.

Type 2 Diabetes

A chronic condition in which the pancreas does not produce enough insulin and/or cells respond differently to insulin in a way that disrupts the metabolism of sugars.

Recommendations

To the US Congress

Overarching Recommendation: Reform the US health and drug pricing systems to ensure that essential medicines, including analog insulin, are affordable to all people who need them in the United States, whether through effective regulation of drug pricing or through meaningful cost mitigation and health insurance coverage. In particular, consider legislation to provide insulin to all insulin-dependent individuals in the country free-of-cost. In the absence of such legislation, promptly:

  • Develop and implement a system to define the fair price for lifesaving medicines like insulin before they are sold in the US. Such post-approval price controls could take many forms, as seen in the systems discussed in this report that peer-income countries have, such as an international reference pricing system as proposed by H.R.3, the Elijah E. Cummings Lower Drug Costs Now Act.
  • Restrict how much manufacturers and intermediaries can increase the prices for essential medicines like analog insulin after they enter the market. Such legislation could take many forms, including direct inflation-caps for drugs that have undergone post-approval price control negotiations or instituting dissuasive financial penalties for manufacturers that increase list prices at rates that exceed inflation.
  • Limit the impact that pharmaceutical rebates and discounts can have in driving up list prices. Such legislation should aim to ensure the affordability of medicines and could take many forms, ranging from prohibiting preferential treatment for high-cost drugs with larger rebates, to banning rebates altogether.
  • Promote the availability of generics and biosimilars, generally, and limit the ability of secondary patents and authorized generics to impede entry of generic competition. Such legislation could take many forms, including reforms to modernize the 1984 Drug Price Competition and Patent Term Restoration Act to ensure that patents and market exclusivity periods do not hinder pharmaceutical innovation and access in the US, including allowing earlier generic entry, especially for lifesaving medications, and strengthening the process for challenging so-called weak patents. Ideally, such legislation should also improve mechanisms for patients and the public to provide input in the decision-making around pharmaceutical patents.
  • Review and eliminate regulatory barriers to the adoption of interchangeable biosimilars for high-cost medicines, such as insulin analogs.
  • Promote the availability and cost-influencing potential of generics, biosimilars and so-called authorized generics, where available. Such legislation could take many forms, such as requiring health insurance formularies to include coverage for authorized generics where the name-brand is also included, and requiring pharmacies to keep lower cost alternatives for any and all name-brand medications available for consumers.
  • Require all businesses that influence drug prices to be transparent on costs and prices for medications, including, among other things, pharmaceutical manufacturers’ list prices, net prices, rebate terms, and research and development costs. Additionally, greater transparency is needed around the ways that manufacturer-sourced rebate funds are used and distributed by pharmacy benefit managers and private health insurance companies.
  • Improve the affordability and availability of health insurance for low- and middle-income earners. In particular, consider legislation to expand coverage for existing social protection programs like Medicaid and Medicare. In the absence of such legislation, however, Congress should provide a floor of protections for uninsured people who are ineligible for Medicaid in their state but would have qualified had their state adopted the so-called Medicaid expansion. Additionally, Congress should extend existing subsidies for private health insurance plans purchased through the Affordable Care Act marketplace by low- and middle-income earners, which were implemented by the American Rescue Plan Act of 2021 but are set to expire in 2022.

To Federal Administrative Agencies

  • Federal departments, including the Department of Health and Human Services and Department of Commerce, and relevant agencies, such as the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and the Patent and Trademark Office, should also implement policies that will help lower prices for lifesaving medications like insulin to levels that ensure their affordable access.
  • To better ensure equal and affordable access to essential medicines, federal agencies should expand interagency collaboration, particularly between the Food and Drug Administration and Patent and Trademark Office.
  • The Patent and Trademark Office should, to the extent that it is able, facilitate the entry of generic competition, especially for lifesaving medications like analog insulin. This may include strengthening the process for challenging so-called weak patents and reversing policies that grant the agency discretion to deny challenges to possibly invalid patents on procedural grounds. The Patent Trial and Appeal Board should also improve data transparency around decisions relating to so-called Orange and Purple Book Patents.
  • The Centers for Disease Control and Prevention should improve the collection and dissemination of national and state-level data on diabetes-related illnesses and deaths. Additionally, the agency should include disaggregated income data in its annual National Diabetes Statistics Report.
  • The Department of Health and Human Services should conduct and publish a study on the administrative feasibility, costs, and benefits of utilizing provisions of the Bayh-Dole Act (35 US Code Chapter 18), including so-called “march-in rights” (§ 203), to foster affordable access to insulin analogs and other unaffordable essential medicines.

To State Governments

  • States that have not implemented the Affordable Care Act’s so-called Medicaid Expansion, which, among other things, expands the public health plan’s coverage to single persons without dependents, should adopt legislation to integrate these components of the program into state laws.
  • State legislators and agencies should, where possible, similarly pass legislation or policies that help lower prices for essential medications like insulin to levels that ensure their affordable access for all residents. Such legislation could take many forms, including price transparency regulations, state-based affordability review boards, and insulin-specific safety net programs.

To Insulin Manufacturers

  • Ensure drug prices are affordable for the most economically vulnerable, such as by lowering list prices to levels that are affordable, including for people without insurance or with inadequate insurance, who are much more likely to be from marginalized communities and working low-income jobs.
  • Conduct human rights due diligence to identify and rectify unfair business practices that cause or contribute to the human rights risks of insulin rationing and the two-tiered system of insulin access.
  • Periodically publish and update information about list and net prices of all branded drugs and generics.
  • If list prices for insulin products are lowered to levels that do not hinder their affordable access, patient assistance programs should operate as comprehensive safety nets for individuals with low socioeconomic status to obtain affordable insulin, including potentially zero-cost insulin. In the absence of such substantive list price reductions, manufacturers should ensure that access to patient assistance programs is both less restrictive and more accessible, including extending benefits to noncitizens and individuals with inadequate insurance, developing rapid access programs for those with an urgent need, reducing time and administrative burdens, and increasing the languages in which applications and evidentiary materials can be submitted.
  • Manufacturers should periodically publish and update information about the number of people served, actual amounts and dosage forms provided, and charitable value derived from noncash donations of pharmaceuticals.
  • Cease any potential rebate practices that may encourage pharmacy benefit managers to prioritize branded insulin over cheaper, generic alternatives.
  • Where resources may be dedicated to physician outreach, inform endocrinologists and other prescribers of insulin about the availability of generics.

To Pharmaceutical Intermediaries

  • All intermediaries in the supply chain between pharmaceutical manufacturers and patients, including wholesalers, pharmacy benefit managers, health plans, and pharmacies should conduct human rights due diligence to identify and rectify practices that cause or contribute to the human rights risks of insulin rationing and the two-tiered system of insulin access.
  • Health insurance providers should ensure that people with diabetes can access their insulin without undue administrative burden or excessive cost, including ensuring that potential cost-sharing measures for insured people with diabetes should be based on the lowest price available, whether that is the net price or list price. Health plan providers should also ensure that rebate funds directly benefit beneficiaries and regularly publish information relating to rebate agreements.
  • Pharmacy benefit managers should develop pricing arrangements with manufacturers that do not result in large annual increases in the manufacturers’ list prices, and should publish information relating to elements of private contracts that influence drug prices, such as terms of rebates and discounts.
  • Pharmacies should consider lowering their markup over acquisition cost for high-price drugs, in order to prevent unnecessary cost inflation that can contribute to the undermining of equal and affordable access to medicines. Additionally, they should publicly publish information relating to acquisition costs and retail prices.
 

Methodology

This report is based on interviews, data analysis, and other secondary research conducted between March and July 2021 as a part of ongoing research into growing healthcare costs, medical debt, and abusive debt collection practices in the United States.

Human Rights Watch interviewed a total of 50 people in the US for this research, including 31 individuals with chronic health conditions. The remaining 19 were experienced professionals or activists including practicing physicians; researchers or organizers from nonprofit healthcare access advocacy organizations; academic researchers covering domestic and international healthcare economics, drug pricing, and insulin access; a reporter covering medical debt; and a hospital administrator.

Of the 31 people with chronic illnesses with whom we spoke:

  • Twenty-five routinely depend on medicines for treatment of chronic health conditions; 18 of them have insulin-dependent diabetes—13 with type 1 diabetes and five with another major chronic health concern in addition to diabetes.
  • Eighteen identified as women, 11 as men, and two as gender non-binary. Three individuals with whom we spoke were in the process of or had already transitioned genders. Of the 18 insulin-dependent individuals, nine identified as women, seven as men, and two as gender non-binary.
  • Three identified as Black, all of whom had insulin-dependent diabetes; one person identified as Latinx, who also had insulin-dependent diabetes.
  • Three lived in each of New York, North Carolina, Indiana, Texas, and Minnesota; two lived in each of Connecticut, Ohio, Colorado, Pennsylvania, and Washington; and one lived in each of the District of Columbia, West Virginia, Rhode Island, Iowa, Florida, and the United Kingdom. The people who require insulin with whom we spoke lived in Florida, Washington, Connecticut, North Carolina, Texas, Minnesota, New York, Pennsylvania, Ohio, Indiana, Rhode Island, or the United Kingdom.

Most interviews with people who require insulin were arranged with help from partner organizations, including Patients for Affordable Drugs, T1International, and Mutual Aid Diabetes. These interviews reflect a range of personal experiences shaped by different state policy environments, private and public insurance programs, income levels, and racial, gender, or sexual identities.

This report focuses on the experiences shared by the 18 people with whom we spoke who depend on insulin to regulate their blood sugar. However, many of the concerns covered in this report that contribute to issues of access and affordability for insulin, including US policy regarding drug pricing, are relevant to, and consistent with, the experiences of each of the 25 medicine-dependent people Human Rights Watch interviewed.

All those interviewed provided verbal informed consent to participate and to have their names and the contents of their interviews reproduced. Where relevant, some individuals requested anonymity to discuss certain subjects. Human Rights Watch notes such incidences in the footnotes of this report when citing to these interviews. No person interviewed received any compensation for their participation.

The number of people we interviewed who require insulin does not constitute a representative sample of all people with insulin-dependent diabetes nationwide. However, their experience is consistent with independent studies, extensive secondary research and data analysis that support a pattern of problems discussed in the report, providing insights for much-needed regulatory reforms.

Because of the Covid-19 pandemic, all interviews were conducted remotely by videoconference or telephone. Every interview was individual, except for two group interviews: one with two individuals who work with the organization, Mutual Aid Diabetes, both of whom have type 1 diabetes; and one with two researchers from a US-based medical school, who are among the 19 professionals consulted for this research.

In addition to interviews, this report draws extensively on publicly available secondary sources of information to corroborate and interpret the experiences of those with whom we spoke, including reports from nongovernmental organizations, federal investigations, publicly released and redacted internal company documents, government and academic studies, publicly available data from federal departments and agencies, medical literature, and relevant local and national reporting. Where relevant, the methodology for charts and data are explained in the footnotes.

Human Rights Watch also conducted price analyses of three of the most widely used insulin analogs: Humalog, Novolog, and Lantus. Each of these drugs is produced by one of the “Big Three” multinational pharmaceutical manufacturers that together control 96 percent of the global market for insulin by volume: the US-based company, Eli Lilly; the Danish company, Novo Nordisk; and the French company, Sanofi. The price analysis component of our research covers these three brands because these were most commonly used and raised by interviewees. Where interviewees or literature discussed other available synthetic human insulins, Human Rights Watch explicitly notes that in the relevant section.

Almost every person with diabetes whom we interviewed was currently using, or had previously used, either Humalog or Novolog, two of the three insulins included in this report, with many having switched between them at some point because of changes in health insurance coverage. Five were currently using or had previously used Lantus, a third brand of insulin that is included in our study.

Human Rights Watch wrote letters to six large companies involved in the insulin supply chain: three manufacturers of the insulins covered in this report, Eli Lilly and Company, Novo Nordisk, and Sanofi; and the three largest pharmacy benefit managers in the United States at time of writing, CVS Health, OptumRx (owned by UnitedHealth Group), and Express Scripts (owned by Cigna). These letters requested information and clarification regarding their practices. Of the six companies we contacted, five provided written responses, including all three manufacturers. Their responses are reflected throughout the report, including in some places to provide important contextual information about industry policies and practices. The complete correspondence with these six companies can be found in an online Annex to this report.

Throughout this report, we also cite to publicly available information provided by these companies, both regular public disclosures and internal documents released following a 2020 Senate Finance Committee investigation.

 

I. Background

No matter what, you have to pay your rent first. But if I’m out of insulin, I’m going to die. So, I stopped paying rent and got evicted. I was homeless. But I never slept on the streets—I was staying with people. But I didn’t have a legal residence for a few years.[1]


— Zoe Witt, type 1 diabetic, Washington, May 12, 2021.

Zoe Witt of Seattle, Washington, left a salaried job with health insurance that covered her insulin needs in 2018 because of the work’s impact on her mental health. “I was suicidal, and I knew I needed to quit the job,” she said. “I quit, which I had never done before because I’m a diabetic and I need health insurance.”[2]

Soon after, she found work as a host in a restaurant, earning about US$13 an hour plus tips. But the position did not include health insurance coverage. Despite picking up extra shifts and working overtime, Zoe’s take-home pay was about $2,200 a month, making her ineligible for Washington State’s Medicaid program.[3] But after paying for rent in a high-cost-of-living area, student loans, utilities, credit card debt, and food, Zoe could not afford to purchase private health insurance either.

Witt told Human Rights Watch that each month she required one vial of both Lantus and Novolog, two commonly prescribed brands of analog insulin. But without insurance, the out-of-pocket cost for her prescribed insulin was about $600 a month, more than a quarter of her take-home pay at that time.[4] So, Witt started stretching her medication and using expired insulin:

It was a very bleak time. I definitely remember feeling really ill.... You think, ‘I haven’t died yet.’ But that whole time, you could be moments from death. And when your blood sugar is that poorly controlled, you are way more at risk for other health issues. And if you don’t have insurance, you are way less likely to go to the hospital if something goes wrong…. I would be throwing up in the middle of a shift in the bathroom at work. Looking back, it was like I was dying.[5]

Her out-of-pocket costs for insulin began to add up. Zoe skipped paying rent to afford her medication, got evicted, and moved in with acquaintances. This continued for almost a year before she was offered a promotion to a position that paid $19 an hour, which allowed her to purchase health insurance.[6]

But the impacts of insulin rationing can be long-lasting.[7] Only months after speaking with Human Rights Watch, Zoe had surgery for an advanced form of diabetic retinopathy and a partially detached retina, common complications of prolonged high blood sugar.[8]

Witt’s story shows some of the struggles that people with insulin-dependent diabetes can experience when their insulin is unaffordable. Lack of affordability endangers their lives and health and deeply impacts their choice of career, performance at work, housing, and overall standard of living.

As of 2018, nearly 27 million adults in the United States have been diagnosed with diabetes, and approximately 8.2 million adults—about 2.5 percent of the total population—use one or more formulations of insulin to regulate their blood sugar.[9] Diabetes disrupts how insulin, a naturally occurring hormone produced by the pancreas, transfers glucose from the blood stream into cells.[10] Type 1 diabetes (T1D) is an auto-immune condition in which the pancreas no longer produces any or sufficient insulin.[11] Type 2 diabetes (T2D), which affects more than 90 percent of people diagnosed with diabetes in the US, occurs when the body is either resistant to the effects of insulin or does not produce enough.[12]

Many people with T2D and all people with T1D depend on externally supplied insulin. Without it, people who require insulin may experience high blood sugar, or hyperglycemia, which can lead to serious and even life-threatening complications.[13] Left unchecked, high blood sugar can kill.[14]

Diabetes is one of the top 10 causes of death around the world and insulin access and affordability is an urgent concern for millions of people living in lower- and middle-income countries. [15] But despite the immense wealth and pharmaceutical production capacity of the US, the country severely underperforms relative to high-income peer nations at ensuring that the medicines needed to effectively manage this disease are affordable.[16]

Since their introduction in the mid-1990s, genetically engineered human insulin analogs (analog insulin) have become the dominant type of insulin prescribed and used in the US, accounting for more than 80 to 90 percent of insulin units used in recent years.[17] Whether analog insulins are generally more effective than older insulins remains a subject of debate in medical literature reviewed by Human Rights Watch, particularly when their cost is considered, but they are far more convenient for patients to regularly use.[18]

Three of the most common name-brand analog insulins are each made by a different manufacturer: Humalog (insulin lispro), made by the US-based Eli Lilly; Novolog (insulin aspart), made by the Denmark-based Novo Nordisk; and Lantus (insulin glargine), made by the France-based Sanofi.[19]

Humalog and Novolog are known as rapid-acting insulins, which quickly reduce blood sugar once introduced into the bloodstream.[20] Lantus is prescribed as a long-acting insulin, which can regulate blood sugars for up to 24 hours and is often used alongside other faster-acting insulins.[21]

These analog insulins are the flagship insulin products for each of these three companies, which controlled 99 percent of the global human insulin market by value and 96 percent of the market by volume in 2016.[22]

Purchasing these drugs from a pharmacy without adequate health insurance coverage or charitable aid in the US can cost more than $300 for a single vial out-of-pocket. But patients with T1D typically require two or three vials of insulin per month, and some patients who are more resistant to insulin, including some with T2D, may need up to six or more vials per month.[23] As described below, these out-of-pocket costs are largely driven by insulin manufacturers’ list prices, which the government does not regulate.

US Analog Insulin Prices

In the US, drug prices are not static, but vary day-to-day, place-to-place and person-to-person. When someone goes to a pharmacy to purchase a drug that is medically prescribed, the out-of-pocket price they must pay for that drug can be influenced by a complicated web of contractual relationships, discounts, and rebates between numerous private intermediaries involved in the supply chain between the drug manufacturer and the patient.[24]

We wrote letters to the three insulin manufacturers included within the scope of this report, requesting information on, among other things, point-of-sale out-of-pocket cost data for their products. Neither Sanofi nor Novo Nordisk provided data responding to this specific request.[25] In its response, Eli Lilly wrote that:

Today, anyone is eligible [under the Lilly Insulin Value Program] to purchase a monthly prescription of Lilly insulin for $35, whether they use commercial insurance, Medicare Part D, Medicaid, or have no insurance at all…. The average monthly out-of-pocket cost for a prescription of Lilly insulin has dropped 27 percent, to $28.05, over the past four years … [the] average monthly prescription of Humalog is 3.3 vials … [and] the average monthly out-of-pocket cost translates to $8.50 per vial.[26]

Eli Lilly’s response to Human Rights Watch did not make clear how many people have been helped through initiatives like the Lilly Insulin Value Program, which was created in 2020 in response to the Covid-19 pandemic, or for how long it will be offered.[27] But these average cost data provided by Eli Lilly include the experiences of people with adequate health insurance and other forms of cost assistance like direct financial aid, and may not reflect the experiences of those who lack such benefits and must pay out-of-pocket for the pharmacy’s full retail price, known as the retail cash price.[28]

Human Rights Watch analyzed retail cash price data from GoodRx, a website commonly used by patients that tracks prescription medication costs and discounts, to create yearly average retail cash price estimates for a 10 mL vial of these three prevalent analog insulins from 2014 to 2021, all years for which this data is publicly available.[29]

According to these GoodRx data, the retail cash price for a 10 mL vial of Humalog increased by more than 45 percent between 2014 and 2021, to about $319 a vial.[30] Novolog increased by more than 53 percent, to about $348 a vial.[31] Lantus increased at a lower rate, 25 percent, as the average price was already higher in 2014, but sold for about $325 a vial in 2021.[32]

Chart 1: Retail Cash Prices for Select Analog Insulins (10 mL vial) Increased Since 2014

Yearly Average Retail Price for Select Insulin Analogs (10 mL vial) from 2014 to 2021

Source: Human Rights Watch analysis of retail price data from Benita Lee, “How Much Does Insulin Cost? Here’s How 27 Brands and Generics Compare,” Goodrx, November 6, 2020, https://www.goodrx.com/blog/how-much-does-insulin-cost-compare-brands/ (accessed September 1, 2021). Human Rights Watch visualized this data. 

As the GoodRx pricing information indicates and Zoe’s story shows, these out-of-pocket costs can quickly add up, especially for people with low incomes.

Drug wholesalers and pharmacies can contribute to these retail cash prices by marking up the price of a drug before it is dispensed to a patient.[33] But the impact of these practices on retail cash prices is limited, as the underlying price that manufacturers set for their drugs—the so-called list price—largely determines the out-of-pocket costs for patients without insurance or assistance.[34]

A number of studies by healthcare economists, advocacy organizations, and federal oversight bodies have documented how these list prices for insulin analogs in the US have rapidly increased since their introduction to the market in the late 1990s and early 2000s.[35]

Human Rights Watch wrote letters to the three insulin manufacturers included within the scope of this report, requesting historic list price data for the three drugs we studied. Their responses, reproduced in full in the Annex to this report, did not provide this data.[36]

Accordingly, we compiled list price data from available sources, including public disclosures by these manufacturers and internal company documents provided to a recent US Senate Finance Committee investigation.[37]

In 1996, Eli Lilly first sold Humalog in the US at a list price of just over $21 for a 10 mL vial, equivalent to about $35 in 2020 when adjusted for inflation.[38] By 2020, however, Humalog’s list price was about $275—a 680 percent inflation-adjusted increase.[39] This increase was 10 times faster than inflation in the general economy and nearly 6 times faster than price inflation in the pharmaceutical sector specifically over this same time period.[40]

After Novo Nordisk’s Novolog and Sanofi’s Lantus were both approved for sale in the US in 2000, their list prices similarly soared past the price inflation for goods and services in other sectors of the economy.[41] Between 2001 and 2018, the most recently available list price data Human Rights Watch was able to gather, Novolog’s list price rose about 403 percent when adjusted for inflation, from about $59 a vial to more than $289.[42] Similarly, between 2001 and 2019, the list price for Lantus rose about 420 percent, from an inflation-adjusted price of about $53 per vial to more than $283.[43] These list price increases for both brands vastly outpaced the price inflation experienced by the entire prescription drug sector during this period, which only grew by 77 percent between 2001 and 2020.[44]

Production Costs and List Price Increases

Available information indicates that these high prices and drastic price increases for analog insulins are not primarily driven by the cost to produce these products. For example, the French insulin manufacturer Sanofi provided data to a US Senate Finance Committee investigation of insulin pricing practices in 2019.[45] In these documents, Sanofi stated that the per-unit manufacturing cost for a 10 mL vial of Lantus in 2018 was $3.61.[46] But that same year, their list price for a 10 mL vial of Lantus was over $266—a markup of several thousand percent.[47]

These documents from Sanofi also revealed that, between 2014 and 2018, their list price for Lantus increased at a rate about three-times faster than the cost to manufacture Lantus. According to these records, the per-unit cost of manufacturing Lantus increased by only 5 percent in total between 2014 and 2018.[48] Meanwhile, Sanofi’s average list price for a 10 mL vial of Lantus grew by a total of 15 percent over this period, from about $230 to $266.[49]

Not all of this markup is profit, as other costs are involved in bringing a vial of insulin to market, including substantial rebates discussed further in Section III. For example, a 2017 study by researchers from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy and Economics estimated the average net profit margins—the percent of total revenue that is profit—for each of the different actors in the US pharmaceutical supply chain: manufacturers, wholesalers, pharmacy benefit managers, pharmacies, and insurers.[50] They found that, on average, nearly a third of drug manufacturers’ revenue from US-based sales of branded and generic drugs compensated for direct production costs, but 26.3 percent of their revenue was profit.[51]

US law currently does not require pharmaceutical companies to disclose drug production costs and companies do not typically publish this information. Accordingly, it is unclear to what degree other costs, in addition to manufacturing, may have influenced the list prices of these analog insulins. Human Rights Watch wrote to the three insulin manufacturers included in this report requesting data on, among other things, gross and per unit manufacturing costs for the insulin analogs covered in this report. Their responses, reproduced in full in the Annex to this report, did not provide this information.

In recent years, the rapid list price increases documented in these data have slowed or ceased, in a context of increased scrutiny by policymakers, patients, advocates, and the media.[52]

In letters to Human Rights Watch, the three insulin manufacturers we studied described different institutional responses to this scrutiny.[53] Since 2016, Novo Nordisk wrote, the company has been “limiting any potential list price increases on medicines to no more than single digit percentages annually.”[54] Similarly, Eli Lilly wrote that the company has not increased the list price for any of their insulin products since 2017.[55]

However, slowing or stopping additional price increases does not ameliorate the negative human rights impacts of already high list prices on the health, lives, and livelihoods of people who cannot afford their medicine.[56] As the experiences of other peer-income nations discussed below show, these high prices are unique to the US among other peer income countries and reflect addressable policy failures.

Comparing US Prices Internationally

Travis Paulson, age 48, of Northern Minnesota, uses several vials of Novolog each month to manage his T1D. He described regularly traveling to Canada to buy Novolog, where a six-month supply costs around US$700, about the price of two vials in the United States.[57]

Buying insulin across the border, where Novolog is more than 92 percent cheaper per dose than in the US, has allowed Paulson to avoid having to ration his insulin—taking it in amounts or manners not recommended by his physician to stretch out his supply—as he did in the past.[58] It has also allowed him to buy surplus insulin supplies that he can share with people in need.[59]

“We’ve seen enough people die,” said Paulson, explaining the motivations of people with diabetes who participate in informal aid networks, which work to ensure access to insulin for those who cannot afford it. “It’s more important to give people what they need,” he said. “If we find out that they are rationing, we send someone out to their house with a few vials.”[60]

But not everyone in the US has access to cheaper medicines purchased abroad.[61] People without the means to access these cheaper international alternatives, in turn, must confront expensive US prices.

Numerous studies have found that the US is an outlier regarding the high cost of per capita spending on prescription drugs when compared with high- and middle-income countries.[62] A 2021 Rand Corporation study found that US drug list prices were 256 percent of the combined average for 32 other countries in the Organization for Economic Co-operation and Development (OECD).[63] Similarly, a 2020 Rand Corporation study commissioned by the US Department of Health and Human Services found that analog insulin list prices in the US were more than 8 times the average across 32 other OECD countries.[64]

In 2018, the US House of Representatives Ways and Means Committee compared the per-dose list prices of 79 different drugs sold in the US to their list prices in 11 other high-income countries.[65] Their study found that drug prices in the US were nearly four times higher than the average price of the same drug abroad, with some drugs 67 times more expensive.[66]

The prices for the three analog insulins we examined—Humalog, Novolog, and Lantus—largely follow the general trend in US drug prices documented in this study, which are far above those in other high-income countries.

According to the House Committee’s data from 2017 and 2018, Humalog’s price was 294 percent higher per dose in the US than the international average.[67] Novolog was more than 320 percent higher.[68] Lantus is a rare example of a drug that was more expensive in several other countries studied by the House Committee, but it still cost 75 percent more in the US than the average price for the same drug abroad.[69]

 

Chart 2: Same Drug, Exorbitant Prices in the US

Select insulin brands’ per-dose list prices were much higher in the US in 2017-2018 than in other countries or regions.

Source: Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/‌files/documents/u.s.%20vs.%20international%20prescription%20drug%20prices_0.pdf, p. 52 (Novolog), p. 53 (Lantus and Humalog). Human Rights Watch visualized this data. 
 

II. The Human Cost of Unaffordable Insulin

We all deserve to live a fulfilled life [but] I don’t see how anyone is able to do that if you have to worry about [either] paying the bills or getting your medicine.


— Sa’Ra Skipper, person with type 1 diabetes, Indiana, June 1, 2021

Insulin Rationing and Diabetes Deaths

Of the 18 people Human Rights Watch interviewed who require insulin, 14 said they have rationed their insulin because of its high cost, taking it in amounts or manners not recommended by their physician to stretch out their supply.[70]

It is difficult to fully quantify how many people have to ration insulin because of costs. Nonetheless, four studies conducted between 2018 and 2021 suggest high rates of insulin rationing in the US and its potentially severe consequences.[71]

A September 2021 study of survey data collected by the advocacy organization T1International found that more than 25 percent of 542 US-based respondents rationed insulin in the past year due to cost.[72] In 2020, the American Diabetes Association estimated that about 650,000 insulin patients were skipping injections or taking less insulin than prescribed.[73] A 2019 survey by researchers at the Yale School of Medicine found that 25 percent of 199 respondents reported underusing prescribed insulin because of the cost within the past year.[74] Similarly, a 2018 American Diabetes Association survey of 535 individuals with diabetes found that 26 percent of respondents regularly took less insulin than prescribed in the past year because of the cost.[75]

“I did it in the past,” said Travis Paulson, age 48, of Minnesota, recalling a prolonged period of insulin rationing after losing his job during the economic recession in 2007.[76] Travis told Human Rights Watch that he has had dozens of eye operations over the past decade to repair damage that he attributes to his insulin rationing.[77] Still, he counted himself lucky to have survived:

I didn’t know you could die from it. I thought that if you went without insulin, you would go blind, lose fingers, toes, or your legs. I was wrong. It may take months for those things to happen, but if you go without insulin for even one night, you can die.[78]

Timely and regular access to insulin is a matter of life or death for people who require it.[79] But it is especially so for the roughly 1.4 million people in the US with T1D, whose bodies do not produce any insulin at all.[80] Without insulin, people with T1D can experience dangerous health complications, including potentially lethal spikes in blood sugar.[81]

The total number of people in the US who die because of an acute hyperglycemic crisis, such as diabetic ketoacidosis (DKA), is unclear.[82] In 2020, the medical journal Diabetes Care published a study of national hospitalization records from 2017, which found that 835 people died after being admitted into a US hospital with a primary diagnosis of DKA that year—nearly 70 people each month.[83]

But these numbers may underestimate the total number of DKA deaths in the US, since this inpatient hospitalization data does not capture deaths that occurred at home or in an emergency room, for example.[84]

“A lot of people get too sick to even get out of bed and they just die,” said Paulson, who participates in an informal aid network that works to ensure access to insulin for those who cannot afford it. “They ration or go without, and they just go to sleep and never wake up.”[85]

Memorials written by family members and published by the organization T1International describe tragic stories of people finding their loved one with T1D dead after rationing their insulin because of its cost.[86]

As many of these memorials illustrate, the dangers of unaffordable insulin are compounded by the high cost of seeking medical care in the US. Danielle Hutchinson, age 27, of Charlotte, North Carolina, explained how medical debt from previous hospital visits has caused her to delay medical care:

Usually, by the time I am in the hospital [it’s] because I’m [already] at DKA…. I don’t want to deal with the hospital costs, so I try to prevent it and reverse the process myself and drink fluids and keep stuff down [but in] the moment, you don’t have the luxury to think about complications because you are more worried about not running out [of insulin].[87]

Allie Marotta, a 27-year-old with T1D who works with Mutual Aid Diabetes, an online-based mutual aid network that raises money for people struggling to afford their diabetes costs, despaired at how often people ration insulin and even die. “[W]e see people who have an urgent need, [but] it was late, and they passed away,” she said. “The toll is death for our community.”[88]

Disparate Burdens for Economically and Socially Marginalized Groups

Imagine you don’t have someone to loan you $250, and you die alone in your living room. But nobody is doing anything about it.... it ticks me off to no end.


                  — Marcus LaCour, person with type 1 diabetes, Ohio, May 26, 2021.

Marcus LaCour, a 35-year-old with T1D from Ohio, described a period when he frequently moved between jobs, changing employer-sponsored health insurance programs, many of which did not adequately cover the cost of his insulin. After exhausting a stockpile of Novolog pens he had slowly saved up, each of which cost about $250 at the time, Marcus started relying on free samples from his doctor.[89]

LaCour said his family’s financial circumstances were dire: “My wife said that she would skip meals to help with the insulin costs.... That’s hard to hear, but I [knew] that I [had] to survive.” For about a year, Marcus managed largely by rationing free insulin product samples from his physician. But one day, his doctor ran out.[90]

Rationing his last insulin pen, LaCour recalled receiving a bill from his pharmacy for US$736. “I call my doctor and he has no more samples,” he said. “I call the insurance company and say that I’m down to my last pen and you all are going to screw me ... There’s no way I can get $730 right now. How am I supposed to get my meds?”[91]

LaCour said that his health insurance provider at the time offered him an appeals process that would have taken 10 days. But before he ran out of insulin, his employer came to his aid:

Had it not been for the fact that my boss loaned me $250 to get an insulin pen, something bad would have happened. At the time, I was making like $23,000 a year [and] I didn’t have any credit cards. So, there was no way for me to put anything on credit. You suffer.[92]

High out-of-pocket costs for essential medicines like analog insulin are inherently regressive, as people living in or near poverty will always pay more, as a share of their income, to satisfy equal medicinal needs than higher-earning people will, unless those costs are mitigated by public or private assistance, like Medicaid.[93]

In turn, this disproportionate impact on economically vulnerable individuals threatens the right to an adequate standard of living for people who require insulin, as the money needed to acquire this lifesaving medicine can come at the expense of food, rent, and secure living conditions.[94]

Communities deprived of social, political, and economic power in the US because of systemic racism or other forms of discrimination are especially impacted by diabetes.[95] Age-adjusted prevalence data from the Centers for Disease Control and Prevention (CDC) shows that diabetes is highly prevalent among the most socioeconomically vulnerable communities in the country, affecting nearly one-in-seven American Indian or Alaskan Native adults and around one-in-eight non-White Hispanic and non-Hispanic Black adults in the US.[96] In contrast, only about one-in-thirteen non-Hispanic, white adults have diabetes.[97]

This disparity in diabetes prevalence is largely driven by T2D, which is much more common among Black, Indigenous, and other communities of color in the US than among the non-Hispanic white population.[98] In turn, this high prevalence reflects the interrelated political, economic, and cultural drivers of socioeconomic marginalization, which shape the social determinants of health—the circumstances in which people are born, live, work, and age.[99]

But disparities based on race and ethnicity are not just reflected in the prevalence of diabetes, they are also reflected in its severity.[100] Black adults, for example, are more than twice as likely as white adults to be hospitalized for DKA.[101] Additionally, while about 356 people with diabetes underwent a lower-limb amputation every day in the US in 2016, Black adults were more than twice as likely to experience a diabetes-related amputation than white adults that year.[102]

Data from a 2017 Yale Diabetes Center survey of 199 people with either T1D or T2D in Connecticut also suggests that the burden of high insulin costs is also borne differently by different racial and ethnic groups.[103]

Although more than one-in-five white respondents rationed insulin in the past year, they were 18 percent less likely to ration insulin than the average.[104] Both Latino/Hispanic and Black respondents, however, were more likely to ration insulin than the average, respectively about 10 and 22 percent more likely.[105]

Chart 3: Cost-Related Insulin Rationing by Race or Ethnicity

One-in-three Black survey respondents rationed insulin, as did more than one-in-four Latino or Hispanic respondents. White respondents were less likely to ration.

Source: Herkert, Vijayakumar, Luo, et al., “Cost-related Insulin Underuse Among Patients with Diabetes,” Jama Internal Medicine, vol. 179(1), pp. 112-114, January 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6583414/. Human Rights Watch visualized this data.

This study also found that patients with lower incomes were more likely to report cost-related underuse.[106] However, the rate of cost-related insulin rationing did not appear to scale linearly with income.[107] Of people earning under $10,000 a year, about 19 percent rationed insulin; this share rose to 25 percent for those earning between $10,000 to $25,000, and then to about 38 percent among individuals earning between $25,000 and $100,000.[108]

The increased incidence of insulin rationing for low and middle-income earners documented by this survey may reflect gaps in coverage for means-tested social health care programs, as those who did not fall in the lowest income brackets, and thus did not qualify for a potentially more robust publicly funded health plan, were more likely to ration insulin.[109]

Chart 4: Cost-Related Insulin Rationing by Annual Income

Middle-Income Respondents Most Likely to Ration Insulin Because of Cost

Source: Herkert, Vijayakumar, Luo, et al., “cost-related insulin underuse among patients with diabetes,” Jama Internal Medicine, vol. 179(1), pp. 112-114, January 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6583414/. Human Rights Watch visualized this data.

Some of the most economically vulnerable people in the US may qualify for Medicaid, the income-based public health insurance program. But income-based eligibility requirements for these public assistance programs can exclude many low-income people who may earn too much to qualify, but not enough to afford private health insurance or the cost of their medicines.[110]

To qualify for Medicaid in 2021, a single person without dependents would need to earn below $17,774 in most states.[111] But in the 12 states that have not adopted the 2010 Affordable Care Act’s so-called Medicaid expansion, no single-person households without dependents are eligible for this crucial safety net program.[112] More than 2 million uninsured adults fall into this coverage gap nationwide, which disproportionately impacts people of color, and especially Black Americans.[113]

In 2017, when the Yale survey was conducted, the national Federal Poverty Level (FPL) for a single-person household was $12,060.[114] That year, Connecticut had a Medicaid income limit for a single-person household without dependents of 138 percent of the FPL, or $16,642.[115] Survey respondents who earned below this cut-off may have been eligible for free insulin through Medicaid. But those who earned more than this income limit were more likely to depend on private health insurance, whether employer-sponsored or self-purchased.

People stuck in this limbo, with an income too high to qualify for income-based public health insurance but too little to afford private insurance, may face unaffordable insulin costs.[116]

Both Sa’Ra Skipper, 25, of Indianapolis, Indiana, and her sister have T1D. Skipper told Human Rights Watch about how her sister purposefully worked lower-paying jobs to qualify for Medicaid and other cost assistance programs, because slightly higher-paying jobs did not pay her enough to afford health insurance that covered her medical expenses. “She gets her insulin covered, but she still doesn’t make a living wage,” Skipper said.[117]

In 2018, Skipper was working a job with health insurance that did not cover her insulin, leaving her with monthly out-of-pocket costs of about $1,000, which she was not able to afford. But Skipper’s sister, who was receiving free insulin from Medicaid, rationed her medicine to share with Skipper. “It felt like I was taking from her,” Skipper said. “We were sharing insulin out of the same vial ... But the system [didn’t] give me any other choice but to make me live this way.”[118]

The consequences were devastating. Skipper described what happened in written testimony to the US House of Representatives Committee on Oversight and Reform in 2019:

One night, I take my night time dose of insulin and leave the vial on the dresser for my sister to see. I assumed that she would think that I had already taken my dose since I left the vial on the dresser, but she didn't.... She thought that I still needed to take my insulin for the evening, so she took less than her normal dose to ensure that there was enough left for me to take. She put herself at risk.... The next day she went into diabetic ketoacidosis (DKA) and had to be hospitalized for 4 days. The veins blew in her body so she had to have a [venous catheter inserted] in her neck and almost went into a diabetic coma.[119]

Skipper watched her sister battle for life: “We almost lost my sister. That was a really tough time, to see my sister laying in a hospital bed because she was just trying to help me out ... she kept me alive.”[120]

The Power of “Good” Insurance

Insurance is always something I think about. With changing jobs, with possible career paths, with who and when I marry.


— Sydnee Griffin, type 1 diabetic, Minnesota, July 7, 2021

Each of the 31 individuals with chronic health conditions Human Rights Watch interviewed described how critical health insurance that offered adequate and affordable coverage for their condition, or the lack of it, was to their lives. For people who require insulin, the need to ensure health insurance that effectively covers usual medical expenses has profound and under-reported impacts on life choices.

“I had to stay in an abusive situation in order to keep my insurance under my father,” said an individual who did not wish to be named as they shared their experiences publicly for the first time.[121] They described how the need to maintain health insurance coverage to afford treatment for their T1D kept them in an abusive household:

I know other people who have been in similar situations, where your health insurance is used as a sticking point, or a dangling point, to stay in harmful situations…. It really creates a power dynamic…. My greatest fear was that if I lost my health insurance, I wouldn’t be able to afford my insulin.[122]

Many of the people who spoke with Human Rights Watch about experiences with insulin rationing were able to eventually secure adequate insurance coverage that has prevented them from rationing. But interviews with Human Rights Watch made clear that high insulin costs can still force individuals with health insurance to face financial hardships that undermine their standard of living.

A 40-year-old father in Texas who spoke with Human Rights Watch estimated that he spent about $30,000 out-of-pocket to pay for insulin for him and his daughter between 2015 and 2020, despite having health insurance through his employer.[123] He explained that the health insurance coverage he received through his former employer had a yearly deductible of around $6,000; accordingly, at the beginning of each year, the deductible reset, and he paid that amount out-of-pocket before the insurer began to cover costs.[124] Year after year, he explained, he would meet his deductible with just a few visits to the pharmacy:

I would get a month’s supply and know [my] bill was $1,200 or $1,300…. [T]here were times I had to make a call: do I push off the mortgage payments this month and pay it late? Or get the insulin?[125]

Approximately 30 percent of US adults with employer-sponsored health insurance are enrolled in one of these so-called high deductible health plans, which the Internal Revenue Service defines as requiring an annual deductible of at least $1,400 for an individual or $2,800 for a family.[126]

Almost every person with diabetes who Human Rights Watch interviewed stressed the importance of finding employment with health insurance coverage. This need, driven by the necessity to mitigate the high price of insulin, profoundly affects decision-making around jobs and careers. The 40-year-old father in Texas described how the cost of insulin has affected his daughter, who just graduated from high school and is preparing to enter college:

It’s heartbreaking… She sees the overwhelming cost [and she’s] not [thinking]: ‘What do I want to do?’ It’s: ‘What field will give me the best insurance to cover these costs that we have?’ … it’s eye-opening to hear [her] say that.[127]

Prescribing Practices and Higher-Priced Insulin Analogs

A contributor to the unaffordability of insulin in the US has been the shift away from synthetic human insulins, which are less expensive but more complicated to use, to more expensive human insulin analogs.[128] While the prices for both synthetic human insulins and human insulin analogs have increased over time, synthetic human insulins, which first came onto the market in the 1970s, are often sold at a much cheaper list price.[129]

While much cheaper, these older synthetic insulins can make effective blood sugar regulation much more difficult.[130] Two types of traditional, synthetic human insulin are sold over the counter for as little as $25 a vial: regular human insulin and Neutral Protamine Hagedorn (NPH) insulin.[131]

Regular human insulin is taken several times a day to manage blood sugar around meals.[132] Compared with rapid-acting insulin analogs, such as Novolog or Humalog, regular insulin stays in the human body for a much longer time and peaks much later after injection.[133] Similarly, NPH insulin, also known as intermediate-acting insulin, provides background blood sugar regulation but has a peak approximately 4 to 6 hours after injection, unlike modern long-acting insulin analogs such as Lantus.[134]

Eli Lilly and Novo Nordisk produce both regular human insulins, Humulin R and Novolin R, as well as NPH insulin, Humulin N and Novolin N, respectively.[135] Both Novolin N and Novolin R are sold over the counter for only about $25 a vial at select stores.[136]

A regimen consisting of these older synthetic human insulins requires a person to adhere to a very rigid diet and schedule corresponding to these drugs’ various peaks and duration of effect.[137] Varying from this rigid routine of carbohydrates and injections could lead to damaging and potentially lethal blood sugar fluctuations.[138] Additionally, this regimen may also require more frequent blood glucose monitoring, which has its own financial costs.[139]

People who cannot afford the out-of-pocket cost for analog insulins, which require a prescription in the US, may transition to synthetic human insulins that are available over the counter in pharmacies. But doing so without adequate medical guidance can be dangerous.

In 2019, USA Today reported that Josh Wilkerson, a 27-year-old with T1D from Virginia, died not long after losing his health insurance and switching to more affordable synthetic insulin.[140] Media reports and memorials written by family members and published by the advocacy organization T1International described similar tragic stories:

  • Meaghan lost her job and health insurance in June 2018. “From what we can piece together,” her sister-in-law wrote, “Meaghan purchased [synthetic insulin] on the 20th of December. We think she put it into her [insulin] pump and we know she did not get help [with the dosage] from her doctor. On December 24th ... Meaghan started getting sick and vomiting.” She died of DKA sometime Christmas evening and was discovered by her roommate the next morning.[141]
  • After Jeremy lost his job and health insurance, he started rationing insulin and switched to synthetic insulin. “He had two drafted text messages on his phone asking for someone to call 911,” his father wrote. “No one was able to get his messages or calls for help, and he was found by his sister a few hours after he died.”[142]
  • Allen started rationing insulin after aging out of health insurance coverage. “When the money started running out, we had to buy the [synthetic] insulin,” his mother Nicole wrote, “and it didn’t work for him. He needed Novolog and Lantus, but we couldn’t afford it. On May 11, 2018, two days before Mother’s Day, I came home and found him. I watched for 2.5 hours while the paramedics tried to save my kid, but they couldn’t. My son was dead.” Allen was 20 years old when he died.[143]

As the stories above show, some individuals are driven to cheaper alternatives to analog insulin because of changes to their health insurance coverage, whether because of a change in employment status or simply because they aged out of coverage under their parent’s health plan.[144]

Medical literature reviewed by Human Rights Watch confirms that these cheaper synthetic human insulins are viable treatments for type 1 or type 2 diabetes, but generally assumes that these drugs will be used either under a physician’s oversight or in a manner consistent with such oversight.[145] In the US, however, people who cannot afford their prescription because of inadequate health insurance may also be unable to afford this necessary oversight.[146] But even if someone has access to a physician, as both the American Diabetes Society and Endocrine Society have noted, many healthcare providers in the US are no longer trained on how to use these older products.[147]

The result is a two-tiered system of insulin access in the US. The high list prices for more convenient insulin analogs effectively limit their access to individuals with adequate health insurance, charitable assistance, or sufficient personal wealth. Despite concerns regarding their effectiveness, low-income and uninsured people in the US often have no choice but to purchase these older synthetic options.[148] Or, as some of the experiences described in this report show, they will pay for as much analog insulin as they can afford and hope not to die.

Manufacturer-Funded Patient Assistance Programs

For many people who do not have health insurance that adequately covers the cost of their insulin, manufacturer-funded charitable initiatives are a last line of defense against unaffordable insulin costs.

Each of the three insulin producers within the scope of this report—Eli Lilly, Novo Nordisk, and Sanofi—offer financial assistance that can reduce or temporarily eliminate out-of-pocket costs for eligible individuals.[149] These initiatives take various forms, including savings cards, co-pay assistance, or even direct charitable aid, where qualified individuals receive free or discounted insulin for a specified period.[150]

We wrote letters to these three insulin manufacturers requesting information on, among other things, data relating to patient assistance requests, including the total number and kinds of applications received, accepted, and denied as well as their methodology in determining such eligibility.[151] While these manufacturers provided some data and highlighted several supportive programs, discussed below, the information they provided was insufficient to determine how many people’s medicine is made affordable through assistance provided by these programs in any given year.

In 2019, Eli Lilly provided more than 1.2 million vials or pens of insulin products to their foundation and more than 287,000 additional vials or pens of insulin products to other charitable organizations.[152] In 2018, Novo Nordisk’s patient assistance program provided free insulin to nearly 60,000 patients, as well as more than $200 million in co-pay assistance.[153] Similarly, Sanofi provides both co-pay assistance, savings cards, and direct aid to patients.[154]

While manufacturer-funded initiatives may provide valuable assistance, they have clearly fallen short of preventing the cost-related insulin rationing and financial hardship described above.[155]

Eligibility for this assistance is often limited.[156] For example, each of these manufacturers’ patient assistance programs (PAP), which offer a free one-year supply of insulin, are only available to either US citizens or permanent residents who lack health insurance coverage for medications, and have a household income at or below 400 percent of the Federal Poverty Level (FPL), or about $51,000 for a single individual without dependents.[157] Additionally, people with government-funded insurance, such as Medicare or Medicaid, are generally not eligible for these programs because of federal restrictions.[158]

But not everyone who is eligible for these patient assistance programs is necessarily aware of them or able to apply for want of required materials or time. Zoe Witt of Seattle, Washington, expressed frustration with the burden that eligibility requirements can place on people in need. “When you’re rationing, you’re literally dying. How are you expected to sift through forms and fill out tax info?”[159]

Additionally, even if someone is accepted into one of these programs, they are generally not immediately accessible for people with urgent needs.[160] For example, Mutual Aid Diabetes, an online mutual aid organization that helps people fund their diabetes costs, received 34 requests from people to help pay for insulin between March and June 2021. Of these requests, 12 had to be addressed through direct peer-to-peer crowdfunding or a referral to community members who participate in insulin supply sharing because there were no feasible options—whether patient assistance programs, coupons, or clinics—that could cover the cost of that individual’s insulin needs before their supply ran out.[161]

In letters to Human Rights Watch, insulin manufacturers described recently created programs implemented in response to the Covid-19 pandemic, such as Eli Lilly’s Insulin Value Program and Novo Nordisk’s Immediate Supply, which can offer quicker and more generally accessible assistance to individuals in urgent need.[162] However, their letters did not make clear how many people have been able to take advantage of these programs or for how long they would be offered.[163]

These manufacturer-funded initiatives can help lessen the burden of these manufacturers’ high insulin prices for some individuals, but they do not present a universal or sustainable model for addressing cost-related insulin access issues. Instead, these programs ameliorate, for some people, the negative impacts of a variable over which these companies have control: the list price of their drugs.

As discussed in the section below, the out-of-pocket costs driven by these high list prices are unique to the US among other peer income countries and reflect structural policy failures.

III. Why Are US Insulin Prices So High?

The list price of insulin, independently set by pharmaceutical manufacturers, is too high for a 100-year-old drug that has seen no significant innovations for decades. For years, insulin manufacturers have used loopholes in the patent system to stifle competition and increase prices.


— Heather Cianfrocco, CEO, OptumRx, Letter to Human Rights Watch, September 20, 2021

Human Rights Watch found three structural causes that drive up insulin prices in the US and contribute to the high prices of other essential medicines: government failure to regulate drug prices before they enter the market; the lack of regulation over manufacturers’ post-approval drug pricing practices and the role of rebates in fueling list price increases; and policy gaps related to patents and market exclusivity that delay generics and extend manufacturers’ market monopolies over prices.

Unregulated Drug Pricing

In each of the 11 high-income countries included in the House Ways and Means Committee’s international drug price comparison discussed in Section I (Australia, Canada, Denmark, France, Germany, Japan, the Netherlands, Portugal, Sweden, Switzerland, and the United Kingdom), regulations require that once a drug is approved for use, its maximum price is negotiated based on various metrics, such as the therapeutic value when compared to available alternatives or a fixed percentage of the average prices paid in other countries.[164]

In sharp contrast, drug approval is the only step needed in the US.[165] US authorities leave it entirely to the discretion of private actors to determine drug prices.[166] There is no system to define a fair price for medicines before they enter the market, or restrict how much manufacturers or intermediaries can increase their prices once they do.[167]

In this unregulated market, insulin list prices averaged $34.75 per dose in the US, more than triple the average of $10.58 in the House report’s 11 comparison countries, each of which have some form of mechanism for regulating drug prices.[168]

Although these countries have different types of price regulations in place, a 2020 study by researchers from Johns Hopkins University’s School of Medicine, Bloomberg School of Public Health, and Carey Business School, suggests that any of these common price-setting systems is more effective at regulating drug prices than the US’s approach.[169]

For example, although Canada, Japan, and the United Kingdom each employ different mechanisms to control drug prices, they paid relatively similar prices for a basket of 79 branded drugs when compared in the aggregate, with some prices higher for certain drugs but lower for others in each country.[170] However, when compared to the US, a policy outlier without any affordability protections that relies on market competition to set drug prices, each of these peer-income countries’ drug prices were considerably lower in almost all cases.[171]

Rebates Fuel List Price Increases

The 2021 Senate Finance Committee report on the factors driving rising insulin costs found that rebates for insulin have risen significantly in recent years, with some pharmacy benefit managers securing rebates for insulins as high as 70 percent of the list price.[172]

These significant rebates, ostensibly designed to help lower premium costs for patients with health insurance, appear to be tied to increasing list prices generally and, according to the Senate Finance Committee, appear to have helped fuel the rapid increases in insulin analog list prices described in Section I, contributing to higher out-of-pocket costs for uninsured and underinsured patients who do not get discounts on the retail price of their medicine.[173]

In the US, manufacturers of similar types of drugs, such as analog insulin, compete for coverage under health insurance plans through a largely unseen system of rebates, where drug manufacturers pay back a certain percentage of their drug’s list price to pharmacy benefit managers (PBMs) and the health plans they represent.[174]

As a result of these rebates, drug manufacturers’ list prices may remain the same or increase while the companies paying for their products may get larger and larger discounts for purchasing them.[175]

Figure 1: US Prescription Drug Supply Chain

Simplified Prescription Drug Supply Chain Comparison for Person without Insurance or with Employer-Sponsored Health Insurance or Medicare

Source: Sood, Shih, Van Nuys, and Goldman, “The Flow of Money Through the Pharmaceutical System,” USC Schaeffer Center for Health Policy & Economics, June 2017, https://healthpolicy.usc.edu/wp-content/uploads/2017/06/usc_flow-of-moneywhitepaper_final_spreads.pdf (accessed September 1, 2021), p. 2.

This rebate system can allow manufacturers to compete with each other without sacrificing revenue.[176] In the absence of competition from generic manufacturers, manufacturers of competing branded drugs can offer more generous rebates than their competitors without impacting their bottom line by simply increasing the list price of their product, which is the underlying variable upon which these rebate calculations are made.[177]

Accordingly, a system that ostensibly is designed to lower drug costs for patients can contribute to increases in the underlying price for those drugs.[178] A 2020 white paper from the University of Southern California’s Schaeffer Center for Health Policy & Economics found that, on average, a $1 increase in the rebate for a drug was associated with a $1.17 increase in the drug’s underlying list price.[179]

The 2021 Senate Finance Committee investigation examined internal documents produced by Eli Lilly, Novo Nordisk, and Sanofi, similarly documenting a close relationship between increases in rebates and corresponding increases in list prices, particularly between 2013 and 2019.[180] Sanofi “aggressively increased its list prices between 2012 and 2014,” the Senate Finance Committee report found, in response to “aggressive rebate and discount activity from Novo Nordisk.”[181] In turn, Novo Nordisk engaged in a “cat-and-mouse strategy of pricing that followed Sanofi’s price increases closely, sometimes mirroring them within days or even hours.”[182]

The influence that rebates have had on list prices is also shown in data published in 2018 by the American Diabetes Association’s Insulin Access and Affordability Working Group, which documented how the list prices for certain analog insulins have increased considerably more than their net prices, the amount that manufacturers receive after rebates and discounts are deducted.[183]

According to data published in their study, the list price for Lantus more than doubled between 2007 and 2016, growing by 252 percent.[184] However, the estimated net price for the drug, which more accurately reflects the revenue Sanofi received from sales of Lantus, increased by only about 57 percent over this period, having declined from a high of over 100 percent in 2014.[185]

Chart 5: Lantus’ Net Prices Increased Slower than List Prices, Decline in Recent Years

Source: Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021).  Human Rights Watch visualized this data.

In letters to Human Rights Watch and other public documents and statements, the three big insulin manufacturers said that their gross revenue from the sale of insulin products had declined in recent years, in large part because of growing rebates.[186] For example, in its response to a Human Rights Watch letter requesting per vial price and cost data for Lantus, Sanofi wrote:

[I]n 2020, 54 percent of Sanofi’s gross sales were given back to payors as rebates ... This marks the third year in a row that Sanofi has paid more than 50% of its revenue in rebates.[187]

In its letter to Human Rights Watch, Sanofi described how the current system, which links supply chain payments with list price, creates “perverse incentives that sometimes feed the cycle of higher list prices paired with higher rebates and fees … [and that] [d]eclining net prices are the result of substantial competition in the diabetes market putting downward pressure on net prices.”[188]

Human Rights Watch also wrote letters to three of the largest PBMs in the US at time of writing, requesting information and clarification regarding their practices.[189] In its response to Human Rights Watch, OptumRx wrote:

[PBMs] are the only part of the drug supply chain that works to lower the price of drugs for our clients and consumers…. Our efforts reduce annual drug costs by $1,600 per person.[190]

Ultimately, many people with health insurance may never notice the list price increases caused by this shadow competition over PBM formularies.[191] But people without insurance or with inadequate insurance, who are much more likely to be from marginalized communities and working low-income jobs, must bear the burden of these list price increases, subsidizing both drug manufacturers’ revenues and other people’s insurance premiums in the process.[192]

Barriers to Generic Manufacturing and Access

Since the 1984 Drug Price Competition and Patent Term Restoration Act, which established this system of federal drug regulations, pharmaceutical innovation and access in the US have operated on the premise that novel drugs are rewarded with high prices during their window of patent protection, with generic competition reducing prices thereafter.[193]

Generics have the same ingredients, dosage forms, strength, route of administration, and other clinical characteristics as branded drugs, but are produced without government-granted monopolies, or patents.[194]

In theory, this system should lower the price of drugs after the expiration of their patent window.[195] A 2017 US Food and Drug Administration study documented how the price discount between a brand-name drug and its generic scales with the number of generic manufacturers.[196] It found that branded drugs underwent a 39 percent average price reduction with a single generic manufacturer on the market, and a 95 percent reduction with six or more generic manufacturers on the market.[197]

However, not all drugs benefit from a timely generic alternative since there are a number of complications and barriers to their production, including potential patent litigation.[198]

Although there are some generic forms of analog insulin currently on the market, these lower-cost alternatives have failed to significantly drive down insulin prices or make insulin widely affordable for those who need it, in part because of their limited accessibility.[199]

For example, Sanofi’s generic version of Eli Lilly’s Humalog and Eli Lilly’s generic version of Sanofi’s Lantus are both commercially available in the US.[200] But after more than four years of market availability, these and other “biosimilar” versions of analog insulins only accounted for about 8 percent of insulin prescriptions in 2020, according to a recent study of outpatient medical visit data.[201]

Additionally, both Novo Nordisk and Eli Lilly have also introduced non-name-brand versions of their drugs into the US market at a lower cost.[202] These are known as authorized generics, and have the same chemical composition as their name-brand version but are sold with a different label and are much cheaper than their branded counterparts, at about half the price of their name-brand versions at time of writing.[203]

The Novo Nordisk-produced generic of Novolog has an average retail price of about $180 per 10 mL vial at time of writing in 2021, almost 50 percent cheaper than the name-brand’s average retail price.[204] In September 2021, after Human Rights Watch had exchanged correspondence with Eli Lilly about this forthcoming report, the company lowered the list price of its self-produced generic to 70 percent cheaper than the list price of name-brand Humalog at time of writing.[205]

But access to these authorized generics is difficult for many patients. In December 2019, the staff for Senators Elizabeth Warren and Richard Blumenthal conducted a national telephone survey of pharmacies to understand why the fill rate for these non-name-brand versions of Humalog and Novolog was so low.[206] They found that 83 percent of the 386 pharmacies contacted across all US states, the District of Columbia and Puerto Rico, did not have Eli Lilly’s Insulin Lispro available, and 69 percent of these pharmacies could not order Insulin Lispro even if the patient did not urgently need it.[207]

After more than a year on the US market, Eli Lilly’s self-authorized generic only accounted for 35 percent of insulin lispro prescriptions filled at pharmacies in March 2020; Humalog, its branded version, accounted for the other 64 percent.[208] This rate has changed little, if at all, since then. In September 2021, Eli Lilly wrote in a letter to Human Rights Watch that the percentage of prescriptions filled with their generic accounted for “nearly one-third of … prescriptions filled for [insulin lispro].”[209] Meanwhile, Novolog’s self-authorized generic, approved in January 2020, amounted to 12 percent of filled prescriptions for insulin aspart after it had been on the market for more than two months.[210]

The rate of change towards these two authorized generics is unusually slow when compared with other drugs.[211] For example, when a different manufacturer began producing a generic version of Viagra, the popular brand of erectile dysfunction drug, the percentage of prescriptions filled for name-brand Viagra dropped by 75 percent within four months.[212]

The cause for this slow transition toward these self-produced generics of Novolog and Humalog is unclear. One possibility is that dynamics in the rebate system are limiting these authorized generics’ placement on health plan formularies, official lists of whether and how health insurance plans cover certain drugs.[213] Regarding patients’ access to the company’s self-authorized generic, Eli Lilly wrote in a letter to Human Rights Watch:

Many people continue to use Humalog because their insurance plans select Humalog for inclusion on formularies and provide low co-pays for the branded version. In fact, only 1 in 3 people in the U.S. who uses insulin has insurance that covers Insulin Lispro…. While Insulin Lispro has provided important savings to many people, Lilly’s experience to date illustrates a dynamic in the insurance market that prevents list price reductions like ours from having a broader impact and gaining widespread formulary access. The rebates Lilly has offered on Insulin Lispro provide payers a net cost that is comparable to branded Humalog. However, because the list price of Insulin Lispro is substantially lower than the list price of Humalog, the total rebate dollars offered on Insulin Lispro are lower. Insulin Lispro is an important step to help reduce patient costs, but it also has exposed a structural flaw in the current system that must be addressed.[214]

Regardless of the cause for this stymied transition, these various generic products’ gradual entrance to the US market has neither driven down the list prices for these widely prescribed name-brand drugs nor ended the ongoing crisis of insulin affordability.

 

IV. International Human Rights Standards

Unaffordable insulin products in the United States, especially insulin analogs, undermine rights protected under international human rights law, including the right to the highest attainable standard of health, the right to equal and affordable access to essential medicines, the right to equal protection under the law, and the right to an adequate standard of living.[215]

Even for those who are able to afford high out-of-pocket costs without resulting to rationing their medicine, allocating necessary funds for insulin may come with opportunity costs for people living with diabetes, limiting access to higher education, home ownership, and other life goals, and resulting in damaging stress and anxiety.

Right to Health and the Right to an Adequate Standard of Living

Health is a fundamental human right indispensable to the exercise of other human rights, and every human being is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity.[216] Unregulated high prices of insulin products, especially insulin analogs, combined with inadequate cost mitigation or health insurance coverage, contribute to out-of-pocket costs that impact the livelihoods of patients and cause damaging and potentially lethal insulin rationing.

The Universal Declaration of Human Rights, which is widely accepted as reflecting customary international law, states that all people have “the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.”[217]

Similarly, the International Covenant on Economic, Social and Cultural Rights (ICESCR) guarantees the rights to “an adequate standard of living” and “the enjoyment of the highest attainable standard of physical and mental health,” including the “prevention, treatment and control of epidemic, endemic, occupational and other diseases” and the “creation of conditions which would assure to all medical service and medical attention in the event of sickness.”[218]

The United States has signed, but not ratified, the ICESCR. As a signatory, the US is obligated to refrain from acts that would defeat the treaty’s object and purpose.[219]

The Committee on Economic, Social and Cultural Rights (CESCR), which interprets the ICESCR, has affirmed that states have “a minimum core obligation to ensure the satisfaction of, at the very least, minimum essential levels of each of the rights.”[220] This duty extends to preventing and protecting against deprivations of individuals’ human rights by businesses and non-state actors, including effective regulation of their activities.[221]

Governments have obligations to ensure health facilities, goods, and services are accessible to everyone without discrimination and affordable for all.[222] The right to health facilities, goods, and services includes “the provision of equal and timely access to basic preventive” services, “appropriate treatment of prevalent diseases,” and “the provision of essential drugs.”[223] States must ensure these health services are economically accessible, meaning “affordable for all” and of good quality, the CESCR has clarified.[224]

Additionally, “when designing a framework on intellectual property rights, consistent with the Universal Declaration of Human Rights and with the right to enjoy the benefits of scientific progress stipulated in article 15” of the ICESCR, the CESCR has warned states they should ensure that intellectual property rights do not lead to denial or restriction of access to essential medicines necessary for the enjoyment of the right to health.[225] CESCR has pointed out that states have a positive duty “to make available and accessible to all persons, without discrimination, especially to the most vulnerable, all the best available applications of scientific progress necessary to enjoy the highest attainable standard of health.”[226]

In 2009, a gathering of experts from UN bodies including the Office of the High Commissioner for Human Rights, the CESCR, the World Intellectual Property Rights Organization, and the World Trade Organization, led by UNESCO and including other experts from academia, issued the Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and its Applications (Venice Statement).[227] The Venice Statement noted, “the intellectual property regime ... is a temporary monopoly with a valuable social function that should be managed in accordance with a common responsibility to prevent the unacceptable prioritization of profit for some over benefit for all.”[228] In the context of the Venice Statement, the CESCR has clarified that states have an obligation to ensure that intellectual property regimes do not create a barrier to accessing health care.[229]

Equal and Affordable Access to Essential Medicines

As documented in this report, the US government has abdicated its obligation to ensure equal and affordable access to essential medicines. In part, this is due to its failure to regulate drug prices, allowing businesses involved in the pharmaceutical supply chain to increase the prices for insulin products, especially insulin analogs, to levels that undermine their equal and affordable access, especially for those from low-income households and other marginalized populations.

In 2013, the UN Special Rapporteur on the highest attainable standard of physical and mental health noted that, “[w]hile several aspects of the right to health are understood to be progressively realizable, certain core obligations cast immediate obligations on States, including the provision of essential medicines to all persons in a non-discriminatory manner.”[230]

The World Health Organization (WHO), maintains an Essential Medicines Library (EML), which is a register of high-priority drugs that should always be available as part of a functioning health system for all people.[231] According to the WHO, essential medicines are those that “satisfy the priority health care needs of the population,” which are “intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford,” and which are “selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.”[232]

Although human insulin was included on the first WHO EML in 1977, long-acting insulin analogs were only added to this list of essential medicines in 2021, apparently delayed over concerns about affordability and access, and rapid-acting insulin analogs have not yet been added.[233] Even so, other high-income governments have long ago taken steps to regulate drug prices overall, including analog insulin prices. Nothing has prevented or now prevents the US government from similarly regulating drug prices, including the prices for analog insulins.

The failure to regulate drug prices, especially analog insulins, combined with inadequate health insurance or cost mitigation, has resulted in a two-tiered, discriminatory system of insulin access. A 2019 national survey of pharmacies estimated that over 18,000 vials of synthetic human insulins, which were originally developed in the 1970s, are sold over the counter each day in the US.[234] Despite concerns regarding their effectiveness, low-income and uninsured people in the US often have no choice but to purchase these older synthetic options, which many healthcare providers are no longer trained on how to use, as they cannot afford analog insulins.[235]

Additionally, the Convention on the Rights of Persons with Disabilities (CRPD), which the US has signed but not ratified, both affirms the right to health for people with disabilities and obligates states to provide health services to people with disabilities designed to minimize and prevent the development of further disabilities.[236] As a signatory to the CRPD, the US government is obligated to refrain from acts that would defeat the treaty’s object and purpose, to “promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity.”[237]

The CRPD has previously found that “a health impairment which initially is conceived of as illness,” such as diabetes, “can develop into an impairment in the context of disability as a consequence of its duration or its chronicity.”[238] As described in this report, widespread cost-based insulin rationing can contribute to the development of long-term disabilities, such as blindness.

Depending on its severity, diabetes can also be considered a protected disability under domestic anti-discrimination law in the US.[239] For example, technical guidance issued by the US Equal Employment Opportunity Commission, which enforces the employment provisions of the Americans with Disabilities Act (ADA) and the ADA Amendments Act of 2008, states that “individuals who have diabetes should easily be found to have a disability [under the ADA] because they are substantially limited in the major life activity of endocrine function.”[240]

The US government’s continued failure to implement policies to prevent the price increases documented in this report, which, combined with inadequate health insurance or cost mitigation policies, have undermined equal and affordable access to insulin analogs and contributed to cost-based rationing, may be inconsistent with its obligations as a signatory to the CRPD.

Equal Protection and Non-Discrimination

The International Covenant on Civil and Political Rights (ICCPR), which the United States has ratified, and the ICESCR guarantee the right to equal treatment and protection under law, without discrimination on the basis of race, ethnicity, national origin, gender, property, or other status, including economic status.[241] The International Convention on the Elimination of All Forms of Racial Discrimination (ICERD), which the United States has ratified, spells out in more detail protections against discrimination on the basis of race, ethnicity, and national origin, among others.[242]

US constitutional law requires a finding of discriminatory intent before courts will rule unconstitutional discriminatory practices that disproportionately burden a racial group.[243] But ICERD goes further, prohibiting policies and practices that have either the purpose or effect of restricting rights because of race.[244] It proscribes apparently race-neutral practices that affect fundamental rights, regardless of racist intent, if those practices create unwarranted racial disparities.

The Committee on the Elimination of Racial Discrimination, which interprets the ICERD, has specifically stated that “indirect—or de facto—discrimination occurs where an apparently neutral provision, criterion or practice would put persons of a particular racial, ethnic or national origin at a disadvantage compared with other persons, unless that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary.”[245]

Under the ICERD, governments may not ignore the need to secure equal treatment of all racial and ethnic groups, but rather must act affirmatively to prevent or end policies with unjustified discriminatory impacts.[246] Governments are obligated to “undertake to prohibit and to eliminate racial discrimination ... notably in the enjoyment of … the right to public health [and] medical care.”[247]

The ostensibly neutral policies of drug companies and government agencies that have discriminatory impacts on particular racial and ethnic groups’ ability to access and use insulin to preserve health and life should therefore be substantially revised to eliminate such discriminatory impacts. Additionally, as discussed above, some non-citizens are unable to access certain patient assistance programs, impacting their basic right to health and essential medicines.[248]

Corporate Human Rights Responsibilities

Even in the absence of regulations, under the UN Guiding Principles on Business and Human Rights (UN Guiding Principles), all businesses have a responsibility to respect human rights and ensure that they do not cause or contribute to actual or potential adverse human rights impacts.[249]

Fundamental to this responsibility is the requirement that companies carry out human rights due diligence to identify the possible and actual human rights impacts of their operations, and to establish meaningful processes to prevent and mitigate those risks and remedy adverse impacts.[250] The process should be ongoing and continuous.[251]

Companies should meaningfully consult with potentially affected groups and other relevant stakeholders at all stages of human rights due diligence.[252] This consultation should be meaningful and go beyond engaging with a few patient representatives.

Human rights due diligence also entails identifying and rectifying business practices with adverse human rights impacts that are part of a company’s operations. The UN Guiding Principles state that businesses should look at their “own activities” and embed human rights policies across “all relevant business functions.”[253]

All companies that have a role in drug-price setting, including pharmaceutical manufacturers, pharmacy benefit managers (PBMs), health plan providers, and pharmacies, should take steps to identify and rectify practices that contribute to rendering insulin unaffordable for people who need it. In the case of price-setting for insulin, human rights risks include insulin rationing and perpetuating a discriminatory and two-tiered system of insulin access.

For pharmaceutical manufacturers, measures that increase retail prices and impediments to more affordable versions of drugs are key human rights concerns that should be mitigated, especially for people who must pay full retail prices for their insulin. Measures to mitigate such harm could include re-evaluating extending market monopolies even after the company has recouped its private investments in the research and development of the drug; examining whether intellectual property litigation prevents cheaper generics from reaching patients in a timely manner; and reassessing practices around rebates to the extent that they perpetuate the risk of rising costs for individuals who must pay full retail prices for their insulin.

Pharmaceutical companies also have responsibilities as outlined in the 2008 Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines (UN Guidelines for Pharmaceutical Companies), issued by the UN Special Rapporteur on the Right to Health.[254]

The 2008 report of the UN special rapporteur on the right to health, an independent expert mandated by the United Nation’s Human Rights Council to explore a special theme or country situation, stated that the responsibilities for ensuring the right to the highest attainable standard of health and enhancing access to medicines is the primary duty of states but pharmaceutical manufacturers also have responsibilities.[255]

While voluntary, the UN Guidelines for Pharmaceutical Companies provide practical, constructive, and specific guidance to drug manufacturers, articulating best practices for realizing their shared human rights responsibilities.[256] The UN Guidelines for Pharmaceutical Companies state that human rights, including the highest attainable standard of health, should be integrated into the operations of pharmaceutical companies, and that specific attention should be given to the impacts of their activities on access to medicine for disadvantaged individuals, communities, and populations, including those living in poverty.[257]

Companies should aim to ensure that medicines are affordable to as many people as possible, the UN Guidelines for Pharmaceutical Companies state, and should give particular attention to ensuring its medicines are accessible to disadvantaged individuals.[258]

Companies should also be as transparent as possible, with a presumption in favor of disclosing information relating to access to medicines, including information about pricing, discount arrangement, quantity and value of drug donations, and the amount of tax benefit arising from its donations.[259]

“Society has legitimate expectations of a company holding the patent on a life-saving medicine,” the UN Special Rapporteur wrote to the General Assembly in 2009.[260] “Because of its critical social function, a patent on a life-saving medicine places important right-to-health responsibilities on the patent holder.”[261]

 

Acknowledgments

This report was researched and written by Matt McConnell, researcher in the Economic Justice and Rights Division of Human Rights Watch.

It was edited by Aruna Kashyap, associate director on corporate accountability, and Lena Simet, senior researcher and advocate on poverty and inequality, in the Economic Justice and Rights Division. Additional reviews were conducted by Kyle Knight, senior researcher, Lesbian, Gay, Bisexual, And Transgender Rights Program; Alison Leal Parker, managing director, US Program; Amanda Klasing, associate director, Women’s Rights Division; Carlos Ríos-Espinosa, senior researcher and advocate, Disability Rights Division; and Arvind Ganesan, director, Economic Justice and Rights Division. Elizabeth Pfiester, founder and executive director of T1International, and Katherine J. Souris, global advocacy consultant with T1International, also provided external specialist review of this report.

Babatunde Olugboji, deputy program director, and Maria McFarland Sánchez-Moreno, senior legal advisor, provided program and legal review, respectively. The charts and figures included in this report were reviewed by Brian Root, senior quantitative analyst. We are also grateful to Lindsey Cherner, associate at Davis Wright Tremaine LLP, for her assistance. Additional editorial assistance was provided by Namratha Somayajula and Jack Spehn, associates in the Economic Justice and Rights Division. Jack Spehn also prepared this report for publication.

We are very grateful to the advocates and non-governmental organizations that assisted with our research, in particular Patients for Affordable Drugs, T1International, and Mutual Aid Diabetes. Above all, Human Rights Watch would like to thank the people who shared their experiences with us.

 

 

[1] Human Rights Watch telephone interview with Zoe Witt, May 12, 2021.

[2] Ibid.

[3] Ibid. Washington State’s Medicaid program’s annual income limit for single individuals without dependents in 2018 was 138 percent of the Federal Poverty Level of $12,140, or $16,753. Kaiser Family Foundation, “Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level,” January 1, 2021, https://www.kff.org/health-reform/state-indicator/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level (accessed September 1, 2021).

[4] Human Rights Watch telephone interview with Zoe Witt, May 12, 2021.

[5] Ibid. See also US Institute of Medicine, Committee on the Consequences of Uninsurance, “Care Without Coverage: Too Little, Too Late,” 2002, https://pubmed.ncbi.nlm.nih.gov/25057604/ (accessed September 1, 2021) (generally discussing the health-related consequences of being uninsured in the US).

[6] Human Rights Watch telephone interview with Zoe Witt, May 12, 2021.

[7] Regarding the relationship between diabetes, blood sugar control, and damage to the eye, see for example “Diabetic retinopathy,” American Optometric Association, https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/diabetic-retinopathy (accessed March 7, 2022).

[8] Ibid. Zoe Witt, “Op-Ed: Like many diabetics, I’ve had to ration my insulin. It doesn’t have to be this way,” (October 7, 2017) https://www.latimes.com/opinion/story/2021-10-07/insulin-cost-cap-democrats-biden-congress (accessed March 7, 2022).

[9] According to the Centers for Disease Control and Prevention, the total number of adults diagnosed with diabetes in the US was 26.8 million in 2018. Centers for Disease Control and Prevention, “National Diabetes Statistics Report, Estimates of Diabetes and Its Burden in the United States,” 2020, https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (accessed September 1, 2021), p. 3. At time of writing, the most recent available data for the total numbers of adults with diabetes in the US who use insulin products were from 2018. The CDC’s Diabetes Atlas found that among adults with diabetes in 2018, 3.6 million people use insulin alone and an additional 4.6 million use both insulin and oral medication to control blood sugar—for a total of 8.2 million. Centers for Disease Control and Prevention, “Diabetes Atlas,” https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html# (accessed September 1, 2021) (searching for “Diabetes Medication Use” under “Indicators” and sorting by “Number in 1,000,000s”). Averaging the US Census Bureau’s estimates of the total resident population of the country for each month of 2018 provides a rough figure of about 329.84 million individuals residing in the US during that year. See US Census Bureau, Population Division, “Table 1. Monthly Population Estimates for the United States: April 1, 2010, to December 1, 2020 (NA-EST2019-01),” https://www.census.gov/data/tables/time-series/demo/popest/2010s-national-total.html (accessed March 8, 2022). Accordingly, we can roughly estimate that about 2.48 percent of the US population relies on one or more formulations of insulin to regulate blood sugar. However, this may undercount the actual prevalence, as insulin-dependent minors are not captured in the Diabetes Medication Use data from the Centers for Disease Control and Prevention.

[10] Mayo Clinic, “Hyperglycemia in diabetes, Overview,” June 27, 2020, https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631  (accessed September 1, 2021). There are other less-common forms of diabetes that may require insulin therapy, such as gestational diabetes, but these are excluded from our analysis. See, for example, International Diabetes Federation, “Diabetes Atlas: 9th Edition,” 2019, https://diabetesatlas.org/en/resources (accessed September 1, 2021), pp. 15-18.

[11] Mayo Clinic, “Hyperglycemia in diabetes, Overview,” June 27, 2020, https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631  (accessed September 1, 2021).

[12] Ibid. 

[13] Ibid. For more information on the relationship between diabetes, blood sugar management and health, please see Centers for Disease Control and Prevention, “Cost-Effectiveness of Diabetes Interventions,” https://www.cdc.gov/chronicdisease/programs-impact/pop/diabetes.htm (accessed September 28, 2021) (“Effective blood sugar management can reduce the risk of eye disease, kidney disease, and nerve disease by 40%.”); United States Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” 2020, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL%201).pdf (accessed September 1, 2021), p. 10; Centers for Disease Control and Prevention, “National Diabetes Statistics Report, Estimates of Diabetes and Its Burden in the United States,” 2020, https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (accessed September 1, 2021), p. 12 (“In 2017, diabetes was the seventh leading cause of death in the United States”); Lin, Xu, Pan, et al., “Global, regional, and national burden and trend of diabetes in 195 countries and territories: an analysis from 1990 to 2025,” Nature, September 8, 2020, https://www.nature.com/articles/s41598-020-71908-9 (accessed September 1, 2021), p. 1 (finding that diabetes has the second biggest effect on reducing life expectancy worldwide).

[14] Mayo Clinic, “Hyperglycemia in diabetes, Overview,” June 27, 2020, https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631 (accessed September 1, 2021) (describing the long-term health impacts of persistent hyperglycemia and the life-threatening nature of acute hyperglycemic crisis events like diabetic ketoacidosis and hyperglycemic hyperosmolar state). See also Michael Fowler, “Hyperglycemic Crisis in Adults: Pathophysiology, Presentation, Pitfalls, and Prevention,” Clinical Diabetes, Vol. 27, December 2009, https://clinical.diabetesjournals.org/content/27/1/19 (accessed September 1, 2021), pp. 19-23.

[15] See, for example, World Health Organization, “Keeping the 100-year-old promise: making insulin access universal,” Access to Medicines and Health Products, November 12, 2021, https://www.who.int/publications/i/item/9789240039100 (accessed December 1, 2021); Lin, Xu, Pan, et al., “Global, regional, and national burden and trend of diabetes in 195 countries and territories: an analysis from 1990 to 2025,” Nature, September 8, 2020, https://www.nature.com/articles/s41598-020-71908-9 (accessed September 1, 2021); Pastakia, Pekny, Manyara and Fischer, “Diabetes in sub-Saharan Africa – from policy to practice to progress: targeting the existing gaps for future care for diabetes,” Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol. 10, pp. 247-263, 2017, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489055/ (accessed September 1, 2021) (“In Mali, for instance, care for a person with diabetes consumes nearly 70% of a family’s income. In Nigeria, a monthly mean cost of $33.10 for a person with diabetes was reported, which corresponds to 29% of the total monthly income of an individual on minimum wage.”); International Diabetes Federation, “Diabetes Atlas: 9th Edition,” 2019, https://diabetesatlas.org/en/resources/ (accessed September 1, 2021), p. 55 (finding a global average of 46.2 percent of deaths due to diabetes occurring before age 60, but 73.1 percent of deaths due to diabetes occurring before age 60 among African nations).

[16] For more information about US and international prices for analog insulins, see Comparing US Prices Internationally, below. See also World Health Organization, “Keeping the 100-year-old promise: making insulin access universal,” Access to Medicines and Health Products, November 12, 2021, https://www.who.int/publications/i/item/9789240039100 (accessed December 1, 2021). While insulin may be the most pressing and often largest expense for a person with diabetes, it is by no means the only expense, as costs for test-strips, devices, and other medications can quickly add up. In 2016, for example, the Healthcare Cost Institute estimated that per-person annual spending on insulin by people with T1D was $5,705, accounting for 31 percent of the over $18,000 in total per-person spending that year. Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices, p. 2. See also The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (“[Nationally it] is estimated that insulin accounts for ~$48 billion (20%) of the direct costs associated with diabetes care.”).

[17] See Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices (accessed September 1, 2021), p. 4 (finding that insulin analogs accounted for more than 90 percent of insulin units used in the US between 2012 and 2016, increasingly slightly over this period); Sarkar, Heyward, Alexander and Kalyani, “Trends in Insulin Types and Devices Used by Adults With Type 2 Diabetes in the United States, 2016 to 2020,” Journal of the American Medical Association, Diabetes and Endocinology, October 12, 2021, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784811 (accessed December 1, 2021) (analyzing millions of outpatient physician-patient interactions between 2016 and 2020 and finding that “Analog insulin use predominated and accounted for more than 80% of total treatment visits across all years” while “The use of biosimilar insulin, which was first approved in 2015, increased from 2.6% in 2017 … to 8.2% in 2020.”).

[18] Although the World Health Organization (WHO) included human insulin on the first Model List of Essential Medicines for Adults (EML) in 1977, long-acting insulin analogs were only added to the EML in 2021, and rapid-acting insulin analogs have not yet been added. See World Health Organization, “WHO prioritizes access to diabetes and cancer treatments in new Essential Medicines Lists,” October 1, 2021, https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists (accessed October 8, 2021). Prior to adding long-acting insulin analogs to the EML, much of the WHO’s comparison between analog insulins and older human insulins rested on the question of cost. See, for example, World Health Organization, Health Technologies and Pharmaceuticals Programme, Regional Office for Europe, “Consideration of diabetes medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML),” 2019, https://www.euro.who.int/__data/assets/pdf_file/0009/436563/2019-EML-DiabetesMeds-eng.pdf (accessed September 1, 2021) (“The guideline panel concluded that the relatively modest overall benefit from insulin analogues was outweighed by the large price difference between human insulin and insulin analogues .”). However, the comparative effectiveness of analog insulins remains a subject of debate in literature reviewed by Human Rights Watch. See, for example, David Beran, Bianca Hemmingsen, and John S. Yudkin, “Analogue insulin as an essential medicine: the need for more evidence and lower prices,” The Lancet, Vol. 7(5), May 1, 2019, https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30111-1/fulltext (arguing that adequate evidence of analog insulin’s superiority to human insulin does not currently exist); Israel Hartman, “Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence,” Clinical Medicine & Research, Vol. 6(2), pp. 54-67, September 2008, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2572551/ (arguing that insulin analogs provide a closer replication of a normal insulin profile). Regarding analog insulin’s relative convenience to use when compared with synthetic human insulin, see University of California, San Francisco, Diabetes Teaching Center, “Human Insulin,” https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/ (accessed September 1, 2021) ("Relative to the rapid-acting insulin analogs, Regular human insulin has undesirable features, such as a delayed onset of action, and variable peak and duration of action when it is injected under the skin. Because of this, fewer and fewer medical providers are prescribing Regular insulin. The delayed onset of action is the reason you have to inject the insulin and wait before eating. And the variable duration of action predisposes to low blood sugars long after the meal is over.”).

[19] See, for example, See Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices (accessed September 1, 2021), p. 5. See also Mulcahy, Whaley, et al., “Comparing Insulin Prices in the U.S. to Other Countries,” RAND Health Care, September 2020, https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/196281/Comparing-Insulin-Prices.pdf (accessed September 1, 2021), p. 5-8 (discussing both the volume and sales shares of analog insulins across OECD countries).  

[20] Ibid., p. 3; See also “Types of Insulin: Topic Overview,” University of Michigan Health, https://www.uofmhealth.org/health-library/aa122570 (accessed September 1, 2021).

[21] Ibid.

[22] Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021) (citing Beran D, Ewen M, Laing R., “Constraints and challenges in access to insulin: a global perspective,” Lancet Diabetes Endocrinology, March 2016, pp. 275–285, https://pubmed.ncbi.nlm.nih.gov/26857998 (accessed March 7, 2022)). See also Beran, Laing, et al., “A perspective on global access to insulin: a descriptive study of the market, trade flows and prices,” Diabetes Medicine, June 2019, 36(6), pp. 726-733, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593686/ (accessed September 1, 2021).

[23] David M. Tridgell, “Insulin is too expensive for many of my patients. It doesn’t have to be,” The Washington Post, June 22, 2017, https://www.washingtonpost.com/outlook/insulin-is-too-expensive-for-many-of-my-patients-it-doesnt-have-to-be/2017/06/22/c5091c42-56cf-11e7-a204-ad706461fa4f_story.html (accessed September 1, 2021).

[24] For more information about the complexity of insulin supply chains specifically, see, for example, Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1300 (discussing the insulin supply chain and pricing mechanisms), p. 1302, Figure 3 (mapping the interrelationships between various actors in the supply chain); Congressional Diabetes Caucus, “Insulin: A Lifesaving Drug Too Often Out of Reach,” November 5, 2018, https://congress.gov/116/meeting/house/109502/documents/HHRG-116-IF02-20190402-SD001.pdf (accessed September 1, 2021), pp. 7-9.

[25] Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021. Novo Nordisk did, however, write that “[s]tudies and clinical experience suggest that three vials are an adequate supply to cover the monthly needs of most people living with diabetes.” Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 2.

[26] Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 1.

[27] Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 1. See also “New $35 Co-Pay Now Available Through Lilly Insulin Value Program in Response to COVID-19 Crisis in U.S.,” PR Newswire, April 7, 2020, http://lilly.mediaroom.com/2020-04-07-New-35-Co-Pay-Now-Available-Through-Lilly-Insulin-Value-Program-in-Response-to-COVID-19-Crisis-in-U-S (accessed March 7, 2022).

[28] Benita Lee, “How Much Does Insulin Cost? Here’s How 27 Brands and Generics Compare,” GoodRx, November 6, 2020, https://www.goodrx.com/blog/how-much-does-insulin-cost-compare-brands/ (accessed September 1, 2021).

[29] Human Rights Watch extracted retail cash price data for a 10 mL (100 units/mL) vial of each of the insulin analogs we studied for all years between 2014 and 2020 from charts published by GoodRx. Ibid. (“This GoodRx analysis is based on a representative sample of U.S. prescription fills (not GoodRx fills) and comes from several sources, including pharmacies and insurers. The reported prices per insulin unit are based on cash prices, the so-called “usual and customary” prices or retail prices at the pharmacy (not including insurance copays or coinsurance).”). For data from 2021, Human Rights Watch manually averaged the retail price listings for a 10 mL vial of each of the drugs we studied from the 10 pharmacies for which GoodRx tracks retail prices, as they appeared in September 2021. GoodRx, “Humalog (Insulin Lispro),” https://www.goodrx.com/humalog?dosage=10ml-of-100-units-ml&form=vial&label_override=Humalog&‌quantity=1&sort_type=popularity (accessed September 1, 2021); GoodRx, “Novolog (Insulin Aspart),” https://www.goodrx.com/novolog?dosage=10ml-of-100-units-ml&form=vial&label_override=Novolog&quantity=1&sort_type=popularity (accessed September 1, 2021); GoodRx, “Lantus (Insulin Glargine),” https://www.goodrx.com/lantus?dosage=10ml-of-100-units-ml&form=vial&label_override‌=lantus&quantity=1&‌sort_type=popularity (accessed September 1, 2021). We then created yearly averages and calculated the price for a 10 mL vial, by multiplying the price per insulin unit with the number of units per vial—1000. Hereinafter, these average out-of-pocket retail price estimates for insulin analogs will be cited to as “Human Rights Watch Analysis of Retail Price Data from Benita Lee, “How Much Does Insulin Cost? Here’s How 27 Brands and Generics Compare,” GoodRx, November 6, 2020, https://www.goodrx.com/blog/how-much-does-insulin-cost-compare-brands/.”

[30] Human Rights Watch Analysis of Retail Price Data from Benita Lee, “How Much Does Insulin Cost? Here’s How 27 Brands and Generics Compare,” GoodRx, November 6, 2020, https://www.goodrx.com/blog/how-much-does-insulin-cost-compare-brands/ (accessed September 1, 2021).

[31] Ibid. 

[32] Ibid.

[33] See, for example, Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021) (“Manufacturers typically sell their medications to wholesalers, who handle distribution to individual pharmacies…. Wholesalers typically purchase the medications for close to the list price, often receiving a handling fee from the manufacturer that is calculated as a fixed percentage of the list price. Wholesalers then sell the medications to pharmacies, with little to no markup. They may, however, charge the higher list price…. Pharmacies dispense the medication to individual patients and collect cost-sharing required by the patient’s health plan (if any). Pharmacies then submit a bill to the individual’s health insurance plan (if any) to be reimbursed for the cost of the medication dispensed to the patient, less any cost-sharing collected, plus a dispensing fee. If a patient does not have or use health insurance for the medication, the pharmacy typically charges the patient a price relatively close to its purchase price, with a markup.”); Elizabeth Seeley, Surya Singh, “Competition, Consolidation, and Evolution in the Pharmacy Market,” The Commonwealth Fund, Issue Brief, August 12, 2021, https://www.commonwealthfund.org/publications/issue-briefs/2021/aug/competition-consolidation-evolution-pharmacy-market (accessed December 1, 2021); Jeroen van Meijgaard, “Here’s the Real Price of Prescription Drugs,” GoodRx, May 11, 2018, https://www.goodrx.com/corporate/news/heres-the-real-price-of-prescription-drugs (accessed December 1, 2021). See also US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 23-24.

[34] Please note that manufacturer’s list prices are also sometimes referred to synonymously with the term wholesale acquisition cost (WAC). The amount that pharmacies markup the drugs that they purchase are highly variable and can depend in part on whether a drug is branded or generic. See, for example, Neeraj Sood et al., “The Flow of Money Through the Pharmaceutical Distribution System,” University of Southern California Leonard D. Schaeffer Center for Health Policy and Economics, June 2017, https://healthpolicy.usc.edu/wp-content/uploads/2017/06/USC_Flow-of-MoneyWhitePaper_Final_Spreads.pdf (finding US pharmacies’ average gross profit margin on branded drug sales to be 3.5 percent, compared with manufacturers’ 76.3 percent; whereas pharmacies’ average gross profit margin on generic drugs was 42.7%, compared to manufacturers’ 29.8%); US Department Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, “Report to the President: Prescription Drug Coverage, Spending, Utilization, and Prices,” March 31, 2000, https://www.aspe.hhs.gov/reports/report-president-prescription-drug-coverage-spending-utilization-prices (accessed December 1, 2021) (“Some industry sources have suggested that retail markups in the range of 20 percent to 25 percent over the pharmacy's acquisition price are typical. This markup includes both the fixed operating costs of the pharmacy as well as taxes and profits. These same sources also suggest that the fixed costs represent most of this markup amount.”). For analysis of how list price increases are passed along to downstream consumers, see Diane Li, at al., “List Price Increases for Medications Lead to Higher Costs for Consumers,” GoodRx Research, December 2020, https://www.goodrx.com/blog/wp-content/uploads/2020/12/List_price_increase_report_goodrx_december_2020.pdf (accessed December 1, 2021), pp.3-5 (“we found 96% and 95% of list price increases resulted in price increases for the [cash price] 1 month later … We found that downstream price increases are just as substantial as the list price increases themselves. Turns out that … 47% of list price increases trickled down to … cash price increases 1 month later…. The average list price increase was 8.4%, with a … corresponding average cash price increase of 7.4%”).

[35] See, for example, United States Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” 2020, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL%201).pdf (accessed September 1, 2021), p. 6 (synthesizing list price increases over the past five years); Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021) (”The average list price of insulin has skyrocketed in recent years, nearly tripling between 2002 and 2013 … The average U.S. list price (WAC) of the four insulin categories increased by 15% to 17% per year from 2012 to 2016”); The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (accessed September 1, 2021); Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices (accessed September 1, 2021), pp. 7-9.

[36] US law does not currently require manufacturers to publicly disclose list price data for their products, and much of these drugs’ historic list price data is not publicly available. Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021; Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021; Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021.

[37] Since list prices can vary over the course of a year, Human Rights Watch aggregated available data into inflation-adjusted yearly averages. While data for Lantus’ list price at market entry was gathered from the Senate Finance Committee investigation, described further below, data for Novolog’s and Humalog’s list prices at market entry were extracted from a graph compiled by Andy Kiersz, quantitative editor at Business Insider, which plotted data provided from Truven Health Analytics. See Ramsey and Kiersz, “The prices for life-saving diabetes medications have increased again,” Business Insider, May 15, 2017, https://www.businessinsider.com/insulin-pricesincreased-in-2017-2017-5 (accessed September 1, 2021). Although these figures are not included in the Senate Finance Committee report, the list price information extracted from this chart has previously been cited to by other federal studies. See Congressional Diabetes Caucus, “Insulin: A Lifesaving Drug Too Often Out of Reach,” November 5, 2018, https://congress.gov/116/meeting/house/109502/documents/HHRG-116-IF02-20190402-SD001.pdf (accessed September 1, 2021), p. 11. For more information about the software used to extract data from these charts, please see Rohatgi, A., “WebPlotDigitizer (Version 4.2),” Computer Software, Published April 2019, https://automeris.io/WebPlotDigitizer/ (accessed September 1, 2021). Eli Lilly and Company’s 2020 Environmental, Social, and Governance (ESG) reports included list price information for a 10 mL vial of Humalog from 2016 to 2020. Eli Lilly and Company, “2020 Environmental, Social, and Governance Report, Access and Affordability,” https://esg.lilly.com/social#tab-control-tab1 (accessed September 1, 2021). List price information for Lantus, from 2014 to 2019, was gathered from documents provided by Sanofi to a Senate Finance Committee investigation. US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), p. 31. Additionally, Sanofi published list price information for 2019 in “How much should I expect to pay for Lantus?”, Fact Sheet, Lantus.com, October 2019, https://www.lantus.com/-/media/EMS/Conditions/Diabetes/Brands/lantus-final/Header/Lantus-Pricing.pdf (accessed September 1, 2021) (listing a vial at $283.56). Novo Nordisk’s disclosures to the Senate Finance Committee investigation provided list price figures for Novolog between 2016 and 2018. US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), Appendix 3, https://www.finance.senate.gov/download/novo_redacted (accessed September 1, 2021), p. 61. The Senate Finance Committee investigation also published Lantus’ 2001 list price based on internal company data. US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf, p. 50 (finding it to have been $34.81). Hereinafter, these average list price estimates for insulin analogs will be cited to as “List Price Data For Humalog, Novolog, And Lantus, Extracted From Various Single-Year And Multi-Year Sources From Market Entry, Including US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf.”

[38] These list price data were adjusted for inflation using US Bureau of Labor Statistics Consumer Price Index annual averages. See US Bureau of Labor Statistics, “Databases, Tables & Calculators By Subject,” https://www.bls.gov/data/ (accessed September 1, 2021). Humalog was approved for sale in the United States by the US Food and Drug Administration on June 14, 1996. Food and Drug Administration, “Drugs@FDA: FDA-Approved Drugs, Biologic License Application (BLA): 020563,” https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020563 (accessed September 1, 2021).

[39] List Price Data For Humalog, Novolog, And Lantus, Extracted From Various Single-Year And Multi-Year Sources From Market Entry, Including US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021).

[40] Ibid. For comparison, Human Rights Watch pulled the Bureau of Labor Statistics’ monthly Consumer Price Index data on All Urban Consumers (Current Series) for the following sectors of the economy for the years between 1996 and 2020: (1) U.S. city average, All items, Seasonally Adjusted; (2) U.S. city average, Prescription drugs, Seasonally Adjusted; (3) U.S. city average, Physicians' services, Seasonally Adjusted; (4) U.S. city average, Hospital services, Seasonally Adjusted. We then created annual averages based on these monthly data for each sector, and then calculated the percent increase between each year’s annual average from the annual average in 1996. Bureau of Labor Statistics, Consumer Price Index (CPI) All Urban Consumers (Current Series), https://www.bls.gov/cpi/data.htm (accessed September 1, 2021). We then calculated both (1) the list price increases for each these three drugs and (2) the CPI price inflation data as a percent difference from their relative baselines—both 1996 and 2001. This partially replicates the analysis conducted by the Insulin Initiative, “The List Price,” https://www.theinsulininitiative.com/the-list-price (accessed September 1, 2021).

[41] Ibid. Novolog was approved for sale in the United States by the US Food and Drug Administration on June 7, 2000, the first full year of available data is for 2001. US Food and Drug Administration, “Drug Approval Package, Application No.: 20-986,” June 7, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm (accessed September 1, 2021). Lantus was approved for sale in the United States by the US Food and Drug Administration on April 20, 2000, the first full year of available data is for 2001. Food and Drug Administration, “Drug Approval Package, Application No.: 21-081,” April 20, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus.cfm (accessed September 1, 2021). Between 2001 and 2018, the last year for which Human Rights Watch has list price estimate data for all three insulin analogs, the price for all goods and services in the US economy grew by about 42 percent (41.78), according to the BLS Consumer Price Index Data. During this period, hospital services increased by 147 percent. Novolog, meanwhile, increased by 614 percent. Lantus’ percent increase stayed well above all the non-insulin sectors of the economy studied, growing by 647 percent between 2001 and 2018.

[42] Adjusted to 2018-dollar amounts. List Price Data For Humalog, Novolog, And Lantus, Extracted From Various Single-Year And Multi-Year Sources From Market Entry, Including US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021). Compare with Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1307, Figure 7 (finding that the list price for a Novolog vial increased by 353 percent between 2001 and 2016 when adjusted for inflation).

[43] Adjusted to 2019-dollar amounts. List Price Data For Humalog, Novolog, And Lantus, Extracted From Various Single-Year And Multi-Year Sources From Market Entry, Including US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021).

[44] Ibid.; Bureau of Labor Statistics, Consumer Price Index (CPI) All Urban Consumers (Current Series), https://www.bls.gov/cpi/data.htm (accessed September 1, 2021).

[45] See US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021).

[46] Ibid., p. 50. Gotham D, Barber MJ, and Hill A., “Production costs and potential prices for biosimilars of human insulin and insulin analogues,” BMJ Global Health, 2018, https://gh.bmj.com/content/bmjgh/3/5/e000850.full.pdf, p. 5.

[47] $266 is a roughly 7,268 percent increase from $3.61. Documents provided by Sanofi to a Senate Finance Committee investigation also included list price information for Lantus, from 2014 to 2019. US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), p. 3. For per unit price information, please see Ibid., pp. 30, 50.

[48] For each of the following years, the listed per-unit manufacturing cost was: 2014, 3.43; 2015, 2.95; 2016, 3.27; 2017, 3.72; 2018, 3.61. The five-year average was 3.39, with a standard deviation for the range of 0.30. See Ibid., Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), p. 50.

[49] List Price Data For Humalog, Novolog, And Lantus, Extracted From Various Single-Year And Multi-Year Sources From Market Entry, Including US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021).

[50] Neeraj Sood et al., “The Flow of Money Through the Pharmaceutical Distribution System,” University of Southern California Leonard D. Schaeffer Center for Health Policy and Economics, June 2017, https://healthpolicy.usc.edu/wp-content/uploads/2017/06/USC_Flow-of-MoneyWhitePaper_Final_Spreads.pdf (accessed March 7, 2022).

[51] Ibid. On average, 28.1 percent of manufacturers’ revenue from US-based sales of name brand drugs was profit according to this study. For generic drugs, this figure was 18.2 percent.

[52] For examples of increased scrutiny from lawmakers, see, for example, Alison Kodjak, “Pharmaceutical Company CEOs Face Grilling In Senate Over High Drug Prices,” National Public Radio, February 26, 2019, https://www.npr.org/sections/health-shots/2019/02/26/698136259/pharmaceutical-company-ceos-face-grilling-in-senate-over-high-drug-prices (accessed September 1, 2021); US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021); Peter Sullivan, “Minnesota AG sues drug companies over insulin price hikes,” The Hill, October 16, 2018, https://thehill.com/policy/healthcare/411662-minnesota-attorney-general-sues-drug-companies-over-insulin-price-spikes (accessed September 1, 2021); Peter Callaghan, “State wins legal challenge to Minnesota’s insulin affordability program,” MinnPost, March 17, 2021; “Maine Makes Insulin More Affordable by Capping Insulin Co-Pays at $35,” American Diabetes Association, March 31, 2020, https://www.diabetes.org/newsroom/press-releases/2020/maine-affordable-insulin (accessed September 1, 2021). For information on online activism from patients, see, for example, T1International, “#insulin4all Action on U.S. Insulin Pricing,” https://www.t1international.com/usainsulin4allaction/ (accessed September 1, 2021).

[53] Aside from the two letters cited below, see Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 11 (“Should Sanofi take a list price increase on one of our medicines, our guiding principle is to limit the total annual increase during our fiscal year … to a level at or below the projected growth rate for National Health Expenditures (NHE) … Should Sanofi take a price increase above the NHE growth rate for a given medicine that results in a list price increase greater than $15 for a full course of treatment per year, we will provide our rationale, highlighting clinical value, real-world evidence, regulatory change, new data or other circumstances that support our decision.”).

[54] “Cognizant of the impact of list prices, Novo Nordisk Inc. has not increased its list price on any of its insulin products in the United States except for one, Xulto-phy, a combination of insulin degludec and liraglutide (a non-insulin GLP-1 RA) since 2019.” Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 1.

[55] Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 3.

[56] For studies quantifying the impact of list price increases on patient out-of-pocket costs, see, for example, Yang, Galan and Thombley, “Changes in Drug List Prices and Amounts Paid by Patients and Insurers,” Journal of the American Medical Association, Health Policy, December 9, 2020, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2773825 (accessed December 1, 2021) (“the median drug wholesale list price … increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%”); Diane Li, at al., “List Price Increases for Medications Lead to Higher Costs for Consumers,” GoodRx Research, December 2020, https://www.goodrx.com/blog/wp-content/uploads/2020/12/List_price_increase_report_goodrx_december_2020.pdf (accessed December 1, 2021).

[57] Human Rights Watch telephone interview with Travis Paulson, April 29, 2021.

[58] Ibid. For international Novolog per-dose prices, see US House of Representatives, Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%f20Drug%20Prices_0.pdf (accessed September 1, 2021), p. 52 (listing Novlog’s per-unit list price in the US as $36.55 and $2.79 in Ontario, Canada).

[59] Human Rights Watch telephone interview with Travis Paulson, April 29, 2021.

[60] Ibid.

[61] As Human Rights Watch has previously documented, transportation is already one of the greatest barriers to life-saving health care faced by Black women in the US. See Human Rights Watch, “It Should Not Happen: Alabama’s Failure to Prevent Cervical Cancer Death in the Black Belt,” November 29, 2018, https://www.hrw.org/report/2018/11/29/it-should-not-happen/alabamas-failure-prevent-cervical-cancer-death-black-belt# (accessed September 1, 2021).

[62] See, for example, Mulcahy, Whaley, et al., “International Prescription Drug Price Comparisons Current Empirical Estimates and Comparisons with Previous Studies,” RAND Corporation Research Report, 2021, https://www.rand.org/pubs/research_reports/RR2956.html (accessed September 1, 2021), p. ix (“In general, the studies that we reviewed found that U.S. prices are considerably higher than those in comparison countries when analyzing all drugs together, including brand-name originator and unbranded generic drugs.”); Dana O. Sarnak, David Squires, and Shawn Bishop, “Paying for Prescription Drugs Around the World: Why Is the U.S. an Outlier?” webpage, Commonwealth Fund, October 5, 2017, https://www.commonwealthfund.org/publications/issue-briefs/2017/oct/paying-prescription-drugs-around-world-why-us-outlier (accessed September 1, 2021). For information on international insulin prices specifically, see, for example, Beran, Laing, et al., “A perspective on global access to insulin: a descriptive study of the market, trade flows and prices,” Diabetes Medicine, June 2019, 36(6), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593686/ (accessed September 1, 2021), pp. 728-29. See also Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 500 (citing Kang, DiStefano, Socal, and Anderson, “Using external reference pricing in Medicare Part D to reduce drug price differentials with other countries,” 2019, Health Affairs, Vol .38(5), pp. 804–811) (“The study also showed that the longer the branded drug remained on the market, the greater the price differential between the United States and these comparison countries. This widening of the price differential is because prices in the United States tend to go up following the drug launch, whereas prices in other countries tend to go down. Other industrialized countries have employed various mechanisms to control postlaunch drug prices, whereas the United States allows pharmaceutical companies to increase drug prices as much as they want based on the market situation throughout the drug life cycle.”).

[63] Mulcahy, Whaley, et al., “International Prescription Drug Price Comparisons Current Empirical Estimates and Comparisons with Previous Studies,” RAND Corporation Research Report, 2021, https://www.rand.org/pubs/research_reports/RR2956.html (accessed September 1, 2021), p. vii. This study also did an analysis of retail prices for the drugs studied, finding that US drug retail prices were 245 percent of the combined average for the 32 OECD comparison countries. Similarly, the subset of biologic drugs in the US, which includes insulin analogs, were 295 percent of the combined international average price. Ibid., p. xiv.

[64] Mulcahy, Whaley, et al., “Comparing Insulin Prices in the U.S. to Other Countries,” RAND Health Care, September 2020, https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/196281/Comparing-Insulin-Prices.pdf (accessed September 1, 2021), p. 12 (Figure 2.10). See also, ibid, p. 5 (finding that, among 33 OECD countries, the US accounted for 31.6 percent of insulin units sold by volume, but 83.6 of all insulin sales in USD).

[65] The 11 comparison countries were: the United Kingdom (UK), Japan, Ontario, Australia, Portugal, France, the Netherlands, Germany, Denmark, Sweden, and Switzerland. US House of Representatives, Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf (accessed September 1, 2021), pp. 3, 17-18.

[66] Ibid.

[67] HRW Analysis of US House of Representatives, Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf (accessed September 1, 2021), p. 52 (Novolog), p. 53 (Lantus and Humalog).

[68] Ibid.

[69] Ibid.

[70] Regarding the four individuals who did not describe insulin rationing: one had a stable history of employer-sponsored health insurance coverage and did not require significant exogenous insulin for the treatment of their type 2 diabetes; one had a history of stable health insurance coverage under their parents health plan and moved to the United Kingdom, where their insulin needs are affordably met without such insurance, before aging out of that coverage; one is an individual with cystic fibrosis, whose health insurance deductible is quickly and regularly met by the total cost of their medications; and one individual was diagnosed with type 1 diabetes later in life, and has managed to maintain adequate, albeit expensive, health insurance coverage to supply their insulin needs.

[71] In addition to the studies on the prevalence of insulin rationing in the US cited below, see, for example, Type1International, “2018 T1International Out-of-Pocket Cost Survey,” 2018, https://www.t1international.com/access-survey/ (accessed September 1, 2021). For more information on the potential health impacts of rationing, see, for example, The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (accessed September 1, 2021), p. 3 (“One study indicates that improved adherence among people with diabetes could prevent nearly 700,000 emergency department visits, 34,100 hospitalizations and save $4.7 billion annually”); Robert A. Gabbay, “Examining the Reality of What Insulin Costs Do to Patients,” Evidence-Based Diabetes Management, Volume 25, Issue 10, September 2019, https://www.ajmc.com/view/examining-the-reality-of-what-insulin-costs-do-to-patients (accessed September 1, 2021) (“The consequences of rationing, such as more time in hyperglycemia or greater risk of diabetic ketoacidosis, increase the likelihood of complications such as blindness and kidney failure.”).

[72] Elizabeth Pfiester, Katarina Braune, et al., “Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1International cross-sectional web-based survey,” Diabetes Research and Clinical Practice, Vol. 179, September 2021, https://www.sciencedirect.com/science/article/pii/S0168822721003557 (accessed October 6, 2021). However, this study also found that other forms of rationing were common among those surveyes. When all international responses were combined, prevalence of “rationing of blood glucose testing strips [41.3%] … was higher than rationing of insulin [25.9%].” Ibid. See also T1International, “2018 T1International Out-of-Pocket Cost Survey,” 2018, https://www.t1international.com/access-survey/ (accessed September 1, 2021).

[73] American Diabetes Association, “Diabetes and COVID-19: New Data Quantifies Extraordinary Challenges Faced by Americans with Diabetes During Pandemic,” July 2020, https://www.diabetes.org/sites/default/files/2020-07/7.29.2020_dQA-ADA%20Data%20Release.pdf (accessed September 1, 2021), p. 4

[74] Patients who reported cost-related insulin underuse in this study were three times more likely to have poor blood sugar control, after adjusting for other factors. Herkert, Vijayakumar, Luo, et al., “Cost-Related Insulin Underuse Among Patients With Diabetes,” Journal of the American Medical Association, Vol. 179, January 2019, https://jamanetwork.com/‌journals/jamainternalmedicine/fullarticle/2717499 (accessed September 1, 2021).

[75] American Diabetes Association and Vault, “Insulin Affordability Survey, 2018,” May 22, 2018, http://main.diabetes.org/dorg/PDFs/2018-insulin-affordability-survey.pdf (accessed September 1, 2021), pp. 8, 16.

[76] Human Rights Watch telephone interview with Travis Paulson, April 29, 2021.

[77] Ibid. Regarding the relationship between diabetes, blood sugar control, and damage to the eye, see for example “Diabetic retinopathy,” American Optometric Association, https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/diabetic-retinopathy (“Over time, diabetes damages small blood vessels throughout the body, including the retina…. When people with diabetes experience long periods of high blood sugar, fluid can accumulate in the lens inside the eye that controls focusing…. Patients with diabetes who can better control their blood sugar levels will slow the onset and progression of diabetic retinopathy.”).

[78] Human Rights Watch telephone interview with Travis Paulson, April 29, 2021.

[79] Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299, (accessed September 1, 2021).

[80] See, for example, Junior Diabetes Research Foundation, “Type 1 Diabetes Facts,” https://www.jdrf.org/t1d-resources/about/facts/ (accessed September 1, 2021); Centers for Disease Control and Prevention, “National Diabetes Statistics Report, Estimates of Diabetes and Its Burden in the United States,” 2020, https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (accessed September 1, 2021), p. 4. See also, the following memorials written by family members of people with T1D who passed after rationing their insulin, Nicole Smith-Holt, “Statement to Eli Lilly,” May 7, 2018, https://www.t1international.com/media/assets/file/Nicole_Smith-Holt_Statement_to_Eli_Lilly_5.7.18.pdf (accessed September 1, 2021); Erin Weaver, “Josh Died Because His Insulin Cost Too Much,” T1Internatonal, August 1, 2019, https://www.t1international.com/blog/2019/08/01/josh-died-because-his-insulin-cost-too-much/ (accessed September 1, 2021); Jazmine Baldwin, “My Sister Jada Should Never Have Died,” July 18, 2019, https://www.t1international.com/blog/2019/07/18/my-sister-jada-should-never-have-died/ (accessed September 1, 2021); Janelle Lutgen, “Remembering Jesse in the Fight for #insulin4all,” T1International, July 1, 2019, https://www.t1international.com/blog/2019/07/01/remembering-jesse-fight-insulin4all/ (accessed September 1, 2021); Joanne Koepp, “Fighting in Micah's Memory,” T1International, February 15, https://www.t1international.com/blog/2019/02/15/fighting-micahs-memory/ (accessed September 1, 2021).

[81] For more information on hyperglycemic crises, see, for example, Mayo Clinic, “Hyperglycemia in diabetes, Overview,” June 27, 2020, https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631 (accessed September 1, 2021); Michael Fowler, “Hyperglycemic Crisis in Adults: Pathophysiology, Presentation, Pitfalls, and Prevention,” Clinical Diabetes, Vol. 27(1), pp. 19-23, December 2009, https://clinical.diabetesjournals.org/content/27/1/19 (accessed September 1, 2021); Juvenile Diabetes Research Foundation, “Diabetic Ketoacidosis (DKA): Symptoms and Prevention,” https://www.jdrf.org/t1d-resources/about/symptoms/ketoacidosis/ (accessed September 1, 2021).

[82] Ibid.

[83] Ramphul and Joynauth, “An Update on the Incidence and Burden of Diabetic Ketoacidosis in the U.S.,” Diabetes Care, October 2020, https://care.diabetesjournals.org/content/diacare/early/2020/10/11/dc20-1258.full.pdf (accessed September 1, 2021). For more information on the National Inpatient Sample that this study analyzed, please see Agency for Healthcare Research and Quality, “Healthcare Cost and Utilization Project, NIS Overview,” April 2021, https://www.hcup-us.ahrq.gov/nisoverview.jsp (accessed September 1, 2021).

[84] This study used data from the National Inpatient Sample (NIS), a database of US regional and national estimates of inpatient utilization, access, charges, quality, and outcomes, published by the Healthcare Cost and Utilization Project of the US Agency for Healthcare Research and Quality. As these are inpatient records, they necessarily exclude data about deaths at home or deaths that occur within the emergency department, which does not require a formal admission into the hospital. See, for example, Centers for Medicare and Medicaid Services, “Inpatient or outpatient hospital status affects your costs,” https://www.medicare.gov/what-medicare-covers/what-part-a-covers/inpatient-or-outpatient-hospital-status (accessed September 1, 2021). Although the limitations of this dataset are not discussed in Ramphul and Joynauth’s study, another study of DKA deaths that relied on this same NIS data noted that “the findings in this report are subject to at least four limitations […] mortality rates at home or in the emergency department setting were not investigated.” Benoit, Zhang, et al., “Trends in Diabetic Ketoacidosis Hospitalizations and In-Hospital Mortality — United States, 2000–2014,” Centers for Disease Control, Morbidity and Mortality Weekly Report (MMWR), Vol. 67(12), pp. 362-365, March 30, 2018, https://www.cdc.gov/mmwr/volumes/67/wr/mm6712a3.htm (accessed September 1, 2021).

[85] Human Rights Watch telephone interview with Travis Paulson, April 29, 2021. See also Mayo Clinic, “Hyperglycemia in diabetes, Overview,” June 27, 2020, https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631 (accessed September 1, 2021) (describing the long-term health impacts of persistent hyperglycemia and the life-threatening nature of acute hyperglycemic crisis events like diabetic ketoacidosis and hyperglycemic hyperosmolar state). See also Michael Fowler, “Hyperglycemic Crisis in Adults: Pathophysiology, Presentation, Pitfalls, and Prevention,” Clinical Diabetes, Vol. 27, December 2009, https://clinical.diabetesjournals.org/content/27/1/19 (accessed September 1, 2021), pp. 19-23.

[86] See, for example, Harry Rybold, “People Over Profit Might Have Saved Jeremy,” T1International, September 27, 2019, https://www.t1international.com/blog/2019/09/27/people-over-profit-might-have-saved-jeremy/ (accessed September 1, 2021); Mindi Patterson, “Losing Meaghan to the Perfect Storm,” T1International, February 8, 2019, https://www.t1international.com/blog/2019/02/08/losing-meaghan-perfect-storm/ (accessed September 1, 2021); Nicole Hood, “I Lost Allen Because He Was Forced to Ration Insulin,” T1International, July 6, 2019, https://www.t1international.com/blog/2019/07/06/rationing-insulin-caused-andys-death/ (accessed September 1, 2021); Sarah Ferguson, “Rationing While Waiting on a Refill Took Kayla’s Life,” T1International, August 29, 2019, https://www.t1international.com/blog/2019/08/29/rationing-while-waiting-refill-took-kaylas-life/ (accessed September 1, 2021); Katherine Reamy, “Losing Andy to America’s Unkind Healthcare System,” T1International, August 26, 2019, https://www.t1international.com/blog/2019/08/26/losing-andy-americas-unkind-healthcare-system/ (accessed September 1, 2021); Cindy Boyd, “Our Jesy, Gone Too Soon,” T1International, August 12, 2019, https://www.t1international.com/blog/2019/08/12/our-jesy-gone-too-soon/ (accessed September 1, 2021); Antroinette Worsham, “Honoring Antavia as I Fight for Affordable Insulin,” T1International, July 25, 2019, https://www.t1international.com/blog/2019/07/25/honoring-antavia-i-fight-affordable-insulin/ (accessed September 1, 2021); Becky Jones, “Losing Rachel, Our Only Daughter,” T1International, June 23, 2019, https://www.t1international.com/blog/2019/06/23/losing-rachel-our-only-daughter/ (accessed September 1, 2021).

[87] Human Rights Watch telephone interview with Danielle Hutchinson, May 25, 2021.

[88] Human Rights Watch telephone interview with Allie Marotta and Emily Miller, May 7, 2021.

[89] Human Rights Watch telephone interview with Marcus LaCour, May 26, 2021.

[90] Ibid.

[91] Ibid.

[92] Ibid.

[93] This regressive impact may be reflected in income-based differences in rates of medicine nonadherence documented in some studies. See, for example, Herkert, Vijayakumar, Luo, et al., “Cost-Related Insulin Underuse Among Patients With Diabetes,” Journal of the American Medical Association, Vol. 179, January 2019, https://jamanetwork.com/‌journals/jamainternalmedicine/fullarticle/2717499 (accessed September 1, 2021) (“Patients with lower incomes were more likely to report cost-related underuse; nearly two-thirds of these patients also experienced difficulty affording diabetes equipment, indicating broader cost barriers to diabetes management.”).

[94] Regarding income-based disparities in the prevalence of diabetes, see, for example, Hill-Briggs, Adler et al., “Social Determinants of Health and Diabetes: A Scientific Review,” Diabetes Care, Vol. 44(1), pp. 258-279, January 2021, https://care.diabetesjournals.org/content/44/1/258 (accessed September 1, 2021) (“Prevalence of diabetes increases on a gradient from highest to lowest income … Compared with those with high income, the relative percentage difference in prevalence of diabetes for those classified as middle income, near poor, and poor, was 40.0%, 74.1%, and 100.4% … T2D was found to be significantly higher and concentrated in census tracts characterized by factors including lower incomes, lower high school graduation rates, more single-parent households, and crowded housing.”).

[95] See, for example, Walker, Williams and Egede, “Impact of Race/Ethnicity and Social Determinants of Health on Diabetes Outcomes,” American Journal of the Medical Sciences, Vol. 351, pp. 366-373, April 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4834895/ (accessed September 1, 2021).

[96] These figures equate to 14.7 percent of American Indian and Alaskan Native (AIAN) adults, 11.7 percent of non-Hispanic Black adults, 12.5 percent of Hispanic adults, and 7.5 percent of non-Hispanic white adults. Note that non-Hispanic Asian adults, as a combined group, had a total prevalence percentage of 9.2, below other communities of color but still above non-Hispanic white adults. However, these prevalence estimates are not evenly distributed among adults of different national or ethnic backgrounds within these cohorts. According to these data, 12.6 percent of Asian Indian adults have diagnosed diabetes, while only 5.6 percent of Chinese adults do. Similarly, although 12.5 percent of Hispanic adults are estimated to have diagnosed diabetes, this cohort prevalence data includes both 6.5 percent of Cuban adults and 14.4 percent of Mexican adults. Additionally, these prevalence data are not evenly distributed among Men and Women within these cohorts. For example, AIAN Women had a prevalence of diagnosed diabetes of 14.8 percent—the second-highest group, behind Mexican Men (16.2 percent)—whereas non-Hispnaic white Women had a prevalence of only 6.6 percent—among the lowest of any group. See Centers for Disease Control and Prevention, “National Diabetes Statistics Report, Estimates of Diabetes and Its Burden in the United States,” 2020, https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (accessed September 1, 2021), p. 16 (Appendix Table 3. Age-adjusted prevalence of diagnosed diabetes by detailed race/ethnicity, education level, and sex among adults aged 18 years or older, United States, 2017–2018).

[97] Ibid.

[98] In contrast, data published by the CDC suggests that the incidence of T1D among non-Hispanic White youth is higher than amog other other cohorts. Ibid., p. 7 (Figure 5). For more information on the differences between T2D and T1D, see, for example, US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 11-13.

[99] See Walker, Williams and Egede, “Impact of Race/Ethnicity and Social Determinants of Health on Diabetes Outcomes,” American Journal of the Medical Sciences, Vol. 351(4), pp. 366-373, April 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4834895/ (accessed September 1, 2021)

[100] Aside from the example given below, see, for example, ibid. (reviewing medical literature discussing race- and ethnic-based differences in clinical outcomes for people with diabetes in the US, with particular focus on glycemic control, blood pressure control, and blood lipid control); Centers for Disease Control and Prevention, “Diabetes Atlas,” https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html# (accessed September 1, 2021) (searching by “Health Status and Disability” and “Visual Impairment”) (most recent available data at time of writing, from 2018, found that the age-adjusted rate of visual impairment for adults with diabetes to be 21.1 percent among non-Hispanic White adults, 27.2 percent among non-Hispanic Black adults, and 31.6 percent among Hispanic adults).

[101] Most recent available data at time of writing, from 2016, found that, when adjusted for age, 15.4 non-Hispanic Black adults per 10,000 are hospitalized for DKA, compared with 7.0 per 10,000 white adults and 5.2 per 10,000 Hispanic adults. See Centers for Disease Control and Prevention, “Diabetes Atlas,” https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html# (accessed September 1, 2021) (searching by “Diabetes-Related Complications” and “Hospitalization for Diabetic Ketoacidosis”).

[102] Ibid. (searching by “Lower Extremity Diseases” and “Hospitalization for Level of Amputation”). In 2016, the most recent available data at time of writing, there were about 130,000 total discharges for lower-limb amputation among adults with diabetes in the US—equating to roughly 356 individual discharges per day over the course of that year. This includes amputations of the toe, foot, below knee, and above knee. When controlling for prevalence, Black adults with diabetes had a combined age-adjusted rate of lower-limb amputation discharge of 6.5 per 1,000 in 2016, compared with 4.5 per 1,000 among white adults and 4.3 among Hispanic adults. However, given the higher prevalence of diabetes among Black and Hispanic adults in the US when compared with white adults, the race- and ethnicity-based differences in age-adjusted discharge rates for lower limb amputation increase significantly when compared to the entire adult population and not just adults with diabetes: 8.7 non-Hispanic Black adults per 10,000; 6.0 Hispanic adults per 10,000; and 3.8 non-Hispanic white adults per 10,000. Accordingly, non-Hispanic Black adults were 128.9 percent more likely than non-Hispanic white adults to be discharged for a diabetes-related lower-limb amputation in 2016.

[103] The survey asked participants about whether they had underused insulin in the past year because of the cost, as well as various demographic factors, such as income. Herkert, Vijayakumar, Luo, et al., “Cost-Related Insulin Underuse Among Patients With Diabetes,” JAMA Internal Medicine, Vol. 179, pp. 112-114, January 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583414/ (accessed September 1, 2021). See also Elijah E. Cummings, “High-Prescription Drug Prices Hurt the Black Community,” The Skanner, August 3, 2017, https://www.theskanner.com/opinion/commentary/25741-high-prescription-drug-prices-hurt-the-black-community (accessed September 1, 2021) (describing the double bind facing Black Americans, who are much more likely to suffer from chronic diseases like diabetes while also earning less than white counterparts at every education level, on average).

[104] 21.5 percent of White respondents compared with 25.5 percent overall. Herkert, Vijayakumar, Luo, et al., “Cost-Related Insulin Underuse Among Patients With Diabetes,” JAMA Internal Medicine, Vol. 179, pp. 112-114, January 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583414/ (accessed September 1, 2021).

[105] Ibid. 28.6 percent of Latino/Hispanic and 32.7 percent of Black respondents compared with 25.5 percent overall.

[106] Ibid.

[107] Ibid.

[108] Ibid.

[109] Ibid.

[110] In addition to income-based requirements, many immigrants without permanent resident status, many of whom come from communities where diabetes is especially prevalent, are ineligible for Medicaid. See Healthcare.gov, “Coverage for lawfully present immigrants,” https://www.healthcare.gov/immigrants/lawfully-present-immigrants/ (accessed September 1, 2021). Undocumented immigrants are more than four-times more likely to be uninsured than US citizens and are accordingly especially vulnerable to insulin costs. “Health Coverage of Immigrants,” Kaiser Family Foundation, July 15, 2021, https://www.kff.org/racial-equity-and-health-policy/fact-sheet/health-coverage-of-immigrants/ (accessed September 1, 2021).

[111] Eligibility for Medicaid is determined by each state and often involves various eligibility metrics, such as household size, number of dependents, and immigration status, but typically requires an otherwise-qualified individual to earn under a certain percentage of the Federal Poverty Level (FPL) to be eligible. See Brooks, Gardner, et al., “Medicaid and CHIP Eligibility and Enrollment Policies as of January 2021: Findings from a 50-State Survey,” Kaiser Family Foundation, March 8, 2021, https://www.kff.org/report-section/medicaid-and-chip-eligibility-and-enrollment-policies-as-of-january-2021-findings-from-a-50-state-survey-report/ (accessed September 1, 2021). The FPL for a single-person household in 2021 was $12,880. US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation,” 2021 Poverty Guidelines,” https://aspe.hhs.gov/2017-poverty-guidelines (accessed September 1, 2021). In most states that have adopted the so-called Medicaid expansion, the Medicaid FPL limit for unmarried adults without dependents is 138 percent of the FPL—or $17,774. See Kaiser Family Foundation, “Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level,” January 1, 2021, https://www.kff.org/health-reform/state-indicator/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level/ (accessed September 1, 2021).

[112] As of time of writing, the 12 states that have not expanded Medicaid coverage to single-person households without dependents are: Alabama, Florida, Georgia, Kansas, Mississippi, Missouri, North Carolina, South Carolina, South Dakota, Tennessee, Texas, and Wyoming. See Kaiser Family Foundation, “Medicaid Income Eligibility Limits for Adults as a Percent of the Federal Poverty Level,” January 1, 2021, https://www.kff.org/health-reform/state-indicator/medicaid-income-eligibility-limits-for-adults-as-a-percent-of-the-federal-poverty-level/ (accessed September 1, 2021). Although Wisconsin has not adopted the Medicaid Expansion under the Affordable Care Act, they have a section 1115 demonstration, which provides Medicaid coverage to some additional low-income adults earning up to 100 percent of the FPL. Note that Missouri and Oklahoma voters approved Medicaid ballot expansion measures in August 2020 and June 2020 respectively. At time of writing, Medicaid expansion implementation for both states were set to begin in 2021. Ibid. See also Brooks, Gardner, et al., “Medicaid and CHIP Eligibility and Enrollment Policies as of January 2021: Findings from a 50-State Survey,” Kaiser Family Foundation, March 8, 2021, https://www.kff.org/report-section/medicaid-and-chip-eligibility-and-enrollment-policies-as-of-january-2021-findings-from-a-50-state-survey-report/ (accessed September 1, 2021); “Oklahoma and the ACA’s Medicaid expansion,” HealthInsurance.Org, June 3, 2021, https://www.healthinsurance.org/medicaid/oklahoma/ (accessed September 1, 2021); “Missouri and the ACA’s Medicaid expansion,” HealthInsurance.Org, June 3, 2021, https://www.healthinsurance.org/medicaid/missouri/ (accessed September 1, 2021).

[113] See Rachel Garfield , Kendal Orgera, and Anthony Damico, “The Coverage Gap: Uninsured Poor Adults in States that Do Not Expand Medicaid,” January 21, 2021, https://www.kff.org/medicaid/issue-brief/the-coverage-gap-uninsured-poor-adults-in-states-that-do-not-expand-medicaid/ (accessed September 1, 2021); Samantha Artiga, Latoya Hill, Kendal Orgera, and Anthony Damico, “Health Coverage by Race and Ethnicity, 2010-2019,” https://www.kff.org/racial-equity-and-health-policy/issue-brief/health-coverage-by-race-and-ethnicity/ (accessed September 1, 2021) (“For example, nonelderly uninsured Black … people more likely than their White counterparts to fall in the coverage gap in states that have not expanded Medicaid, and uninsured nonelderly Hispanic and Asian people are more likely to be ineligible for coverage due to immigration status, reflecting higher shares of noncitizens among these groups.”).

[114] US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation,” 2017 Poverty Guidelines,” https://aspe.hhs.gov/2017-poverty-guidelines (accessed September 1, 2021).

[115] HealthInsurance.Org, “Connecticut and the ACA’s Medicaid expansion,” November 13, 2018, https://www.healthinsurance.org/medicaid/connecticut/ (accessed September 1, 2021).

[116] See, for example, Vincent Rajkumar, “The High Cost of Insulin in the United States: An Urgent Call to Action,” Commentary, Mayo Clinic Proceedings, Vol. 95, pp. 22-28, https://www.mayoclinicproceedings.org/article/S0025-6196(19)31008-0/fulltext (accessed September 1, 2021) (“people without insurance … including people who cannot afford insurance (but are not poor enough to qualify for Medicaid or patient assistance programs) bear the full brunt of the list price.”).

[117] Human Rights Watch telephone interview with Sa’Ra Skipper, June 1, 2021.

[118] Ibid.

[119] Sa’Ra Skipper, “AIN, Sa'Ra Skipper Testimony,” US House of Representatives, https://www.congress.gov/116/meeting/house/109861/witnesses/HHRG-116-GO00-Wstate-SkipperS-20190726.pdf (accessed September 1, 2021).

[120] Human Rights Watch telephone interview with Sa’Ra Skipper, June 1, 2021.

[121] Human Rights Watch telephone interview with anonymous individual July 2021.

[122] Ibid.

[123] Human Rights Watch telephone interview with anonymous individual, May 2021.

[124] Ibid.

[125] Ibid.

[126] United States Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” 2020, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL%201).pdf (accessed September 1, 2021), p. 28.

[127] Human Rights Watch telephone interview with anonymous individual, May 2021.

[128] Regarding this shift in prescribing practices, see, for example, Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021) (“Another important trend affecting overall costs for insulin in the last decade is the shift in insulin utilization from the less expensive human insulins to more expensive human insulin analogs.”). See also Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices (accessed September 1, 2021), p. 4 (finding that insulin analogs accounted for more than 90 percent of insulin units used in the US between 2012 and 2016, increasingly slightly over this period); Sarkar, Heyward, Alexander and Kalyani, “Trends in Insulin Types and Devices Used by Adults With Type 2 Diabetes in the United States, 2016 to 2020,” Journal of the American Medical Association, Diabetes and Endocinology, October 12, 2021, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784811 (accessed December 1, 2021) (analyzing millions of outpatient physician-patient interactions between 2016 and 2020 and finding that “Analog insulin use predominated and accounted for more than 80% of total treatment visits across all years” while “The use of biosimilar insulin, which was first approved in 2015, increased from 2.6% in 2017 … to 8.2% in 2020.”). Regarding analog insulin’s relative convenience to use when compared with synthetic human insulin, see, for example, University of California, San Francisco, Diabetes Teaching Center, “Human Insulin,” https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/ (accessed September 1, 2021) ("Relative to the rapid-acting insulin analogs, Regular human insulin has undesirable features, such as a delayed onset of action, and variable peak and duration of action when it is injected under the skin. Because of this, fewer and fewer medical providers are prescribing Regular insulin. The delayed onset of action is the reason you have to inject the insulin and wait before eating. And the variable duration of action predisposes to low blood sugars long after the meal is over.”).

[129] Goldstein, Patel, Bland, et al., “Frequency of Sale and Reasons for Purchase of Over-the-Counter Insulin in the United States, Journal of the American Medical Association, Vol. 179(5), pp. 722-727, February 18. 2019, https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2724389 (accessed September 1, 2021) (“While the prices of both types of insulin have increased, the difference in pricing between them has substantially added to insulin costs.”). See also Jeremy Greene, Kevin Riggs, “Why Is There No Generic Insulin? Historical Origins of a Modern Problem,” The New England Journal of Medicine, 2015, No. 372:12, https://www.nejm.org/doi/full/10.1056/NEJMms1411398 (accessed September 1, 2021), p. 1172 (discussing the series of innovations in insulin development).

[130] See, for example, University of California, San Francisco, Diabetes Teaching Center, “Human Insulin,” https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/ (accessed September 1, 2021).

[131] See University of California, San Francisco, Diabetes Teaching Center, “Human Insulin,” https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/ (accessed September 1, 2021); Goldstein, Patel, Bland, et al., “Frequency of Sale and Reasons for Purchase of Over-the-Counter Insulin in the United States, Journal of the American Medical Association, Vol. 179, pp. 722-727, February 18. 2019, https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2724389 (accessed September 1, 2021).

[132] See “Types of Insulin: Topic Overview,” University of Michigan Health, https://www.uofmhealth.org/health-library/aa122570 (accessed September 1, 2021); University of California, San Francisco, Diabetes Teaching Center, “Human Insulin,” https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/ (accessed September 1, 2021).

[133] Ibid.

[134] Ibid.

[135] See GoodRx, “Humulin R,” https://www.goodrx.com/humulin-r (accessed September 1, 2021); GoodRx, “Humulin N,” https://www.goodrx.com/humulin-n (accessed September 1, 2021); GoodRx, “Novolin R,” https://www.goodrx.com/novolin-r (accessed September 1, 2021); GoodRx, “Novolin N,” https://www.goodrx.com/novolin-n (accessed September 1, 2021).

[136] See GoodRx, “Novolin R,” https://www.goodrx.com/novolin-r (accessed September 1, 2021); GoodRx, “Novolin N,” https://www.goodrx.com/novolin-n (accessed September 1, 2021); Julia Belluz, “Walmart’s $25 insulin can’t fix the diabetes drug price crisis,” Vox, April 11, 2019, https://www.vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion (accessed September 1, 2021); Natalie Shure, “Walmart’s Play for the Insulin Market Is the Latest Crack in Our Broken Health Care System,” The New Republic, July 6, 2021, https://newrepublic.com/article/162906/walmart-insulin-market-health-care-system (accessed September 1, 2021). See also See US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, Appendix 3, https://www.finance.senate.gov/download/novo_redacted (accessed September 1, 2021), p. 3.

[137] See Ginger Vieira, “Everything You Need to Know About Walmart Insulin,” Diabetes Strong, January 24, 2020 (Updated March 18, 2020), https://diabetesstrong.com/walmart-insulin/ (accessed September 1, 2021).

[138] Julia Belluz, “Walmart’s $25 insulin can’t fix the diabetes drug price crisis,” Vox, April 11, 2019, https://www.vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion (accessed September 1, 2021) (citing Goldstein, McCrary, and Lipska, “Is the Over-the-Counter Availability of Human Insulin in the United States Good or Bad?,” Journal of the American Medical Association Internal Medicine, Vol. 178(9), pp. 1157-1158, https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2687531 (accessed September 1, 2021)).

[139] For information on costs related to blood glucose monitoring, see, for example, Health Care Cost Institute, “Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices,” January 2019, https://healthcostinstitute.org/diabetes-and-insulin/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices, p. 2.

[140] Joshua Bote, “A man who switched to more affordable insulin died. Here's what happened in the viral story,” USA Today, August 9, 2019, https://www.usatoday.com/story/news/nation/2019/08/09/man-dies-otc-insulin/1942908001/ (accessed September 1, 2021). See also Erin Weaver, “Josh Died Because His Insulin Cost Too Much,” T1Internatonal, August 1, 2019, https://www.t1international.com/blog/2019/08/01/josh-died-because-his-insulin-cost-too-much/ (accessed September 1, 2021).

[141] Mindi Patterson, “Losing Meaghan to the Perfect Storm,” T1International, February 8, 2019, https://www.t1international.com/blog/2019/02/08/losing-meaghan-perfect-storm/ (accessed September 1, 2021). See also Ken Alltucker, “Struggling to stay alive: Rising insulin prices cause diabetics to go to extremes,” USA Today, March 21, 2019, https://www.usatoday.com/in-depth/news/50-states/2019/03/21/diabetes-insulin-costs-diabetics-drug-prices-increase/3196757002/ (accessed December 1, 2021).

[142] Harry Rybolt, “People Over Profit Might Have Saved Jeremy,” T1International, September 27, 2019, https://www.t1international.com/blog/2019/09/27/people-over-profit-might-have-saved-jeremy/ (accessed September 1, 2021). See also Shari Rudavsky, “'This is just a rip off': Expensive insulin contributed to man's death at age 39,” Indianapolis Star, December 29, 2019, https://www.indystar.com/story/news/health/2019/12/29/diabetes-lead-to-death-who-cant-afford-insulin/2617976001/ (accessed December 1, 2021).

[143] Nicole Hood, “I Lost Allen Because He Was Forced to Ration Insulin,” T1International, July 6, 2019, https://www.t1international.com/blog/2019/07/06/rationing-insulin-caused-andys-death/ (accessed September 1, 2021). See also Adela Uchida, “Cost of prescription drugs, like insulin, weighs heavily on the minds of Democratic voters,” CBS Austin, March 1, 2020, https://cbsaustin.com/news/local/cost-of-prescription-drugs-like-insulin-weighs-heavily-on-the-minds-of-democratic-voters (accessed December 1, 2021).

[144] Several individuals who spoke with Human Rights Watch described the age 26 as particularly significant for people with chronic health conditions. This is because the Affordable Care Act requires all private health insurance plans that offer coverage to dependent children, whether purchased on the individual marketplace or through an employer, to make that dependent child coverage available until a child reaches the age of 26. US Department of Labor, “Young Adults and the Affordable Care Act: Protecting Young Adults and Eliminating Burdens on Businesses and Families FAQs,” https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/young-adult-and-aca (accessed September 1, 2021).

[145] The comparative effectiveness of analog insulins remains a subject of debate in literature reviewed by Human Rights Watch. See, for example, David Beran, Bianca Hemmingsen, and John S. Yudkin, “Analogue insulin as an essential medicine: the need for more evidence and lower prices,” The Lancet, Vol. 7(5), May 1, 2019, https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30111-1/fulltext (arguing that adequate evidence of analog insulin’s superiority to human insulin does not currently exist); Israel Hartman, “Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence,” Clinical Medicine & Research, Vol. 6(2), pp. 54-67, September 2008, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2572551/ (arguing that insulin analogs provide a closer replication of a normal insulin profile); see, for example, Jeremy Greene, Kevin Riggs, “Why Is There No Generic Insulin? Historical Origins of a Modern Problem,” The New England Journal of Medicine, 2015, No. 372:12, https://www.nejm.org/doi/full/10.1056/NEJMms1411398, pp. 1173-74 (accessed September 1, 2021) (“it has yet to be shown that analogues lead to better long-term outcomes than standard recombinant human insulin does.”); David Beran, Bianca Hemmingsen, and John S. Yudkin, “Analogue insulin as an essential medicine: the need for more evidence and lower prices,” The Lancet, Vol. 7(5), May 1, 2019, https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30111-1/fulltext (accessed September 1, 2021) (arguing more evidence of analog insulins’ advantages over regular human insulin is needed); Wolfgang Landgraf and Juergen Sandow, “Recombinant Human Insulins – Clinical Efficacy and Safety in Diabetes Therapy,” European Endocrinology, Vol. 12(1), pp. 12-17, March 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813452/ (accessed September 1, 2021) (“When considering efficacy, there is clearly an established place for human insulin formulations in the therapy of type 1 (multiple daily injections) and type 2 diabetes.… When comparing cost of therapies, recombinant human insulin formulations are the choice for countries in patients with limited resources.”). See also Julia Belluz, “Walmart’s $25 insulin can’t fix the diabetes drug price crisis,” Vox, April 11, 2019, https://www.vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion (accessed September 1, 2021) (“Human insulins are a reasonable option for many patients with Type 2 diabetes … But the drug isn’t optimal for everybody.”).

[146] Nearly 30 million people—9.2 percent of the country—are uninsured. Human Rights Watch Analysis of Kaiser Family Foundation, “Health Insurance Coverage of the Total Population,” 2019, https://www.kff.org/other/state-indicator/total-population (accessed September 1, 2021).

[147] See Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1310; The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (accessed September 1, 2021), p. 4.

[148] A 2019 national survey of pharmacies estimated that over 18,000 vials of synthetic human insulin are sold over the counter each day in the US. This study found that more than half of the pharmacies surveyed were aware of patients who purchased these older synthetic human insulins because they could not afford the copay for their prescription. Goldstein, Patel, Bland, et al., “Frequency of Sale and Reasons for Purchase of Over-the-Counter Insulin in the United States, Journal of the American Medical Association, Vol. 179(5), pp. 722-727, February 18. 2019, https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2724389 (accessed September 1, 2021).

[149] J. Hunter Fraker and Mariana P. Socal, “Manufacturer-Sponsored Cost-Sharing Programs for Insulin: Are Patients Getting the Help They Need?”, Journal of General Internal Medicine, 23 May 2021, https://link.springer.com/article/10.1007/s11606-021-06892-5 (accessed September 1, 2021) (outlining the various patient assistance programs available for people with insulin-dependent diabetes in the US). See also Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 2-3; Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 2-3; and Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 5-11.

[150] For additional information about each manufacturer’s programs, see also US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf, Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 25; Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), pp. 26-30; and Appendix 3, https://www.finance.senate.gov/download/novo_redacted (accessed September 1, 2021), pp. 3, 52-54.

[151] Both our letters to these manufacturers and their responses can be viewed in full in the Annex to this report.

[152] Ibid., Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 25.

[153] Ibid., Appendix 3, https://www.finance.senate.gov/download/novo_redacted (accessed September 1, 2021), pp. 3, 52-54.

[154] Ibid., Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), pp. 26-30. See also Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 5-11.

[155] In 2020, the American Diabetes Association estimated that about 650,000 insulin patients were skipping injections or taking less insulin than prescribed. American Diabetes Association, “Diabetes and COVID-19: New Data Quantifies Extraordinary Challenges Faced by Americans with Diabetes During Pandemic,” July 2020, https://www.diabetes.org/sites/default/files/2020-07/7.29.2020_dQA-ADA%20Data%20Release.pdf (accessed September 1, 2021), p. 4. See also, Elizabeth Pfiester, Katarina Braune, et al., “Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1International cross-sectional web-based survey,” Diabetes Research and Clinical Practice, Vol. 179, September 2021, https://www.sciencedirect.com/science/article/pii/S0168822721003557 (accessed October 6, 2021) (finding that more than 25 percent of 542 US-based respondents rationed insulin in the past year due to cost); Patients who reported cost-related insulin underuse in this study were three times more likely to have poor blood sugar control, after adjusting for other factors. Herkert, Vijayakumar, Luo, et al., “Cost-Related Insulin Underuse Among Patients With Diabetes,” Journal of the American Medical Association, Vol. 179, January 2019, https://jamanetwork.com/‌journals/jamainternalmedicine/fullarticle/2717499 (accessed September 1, 2021) (finding that 25 percent of 199 respondents reported underusing prescribed insulin because of the cost within the past year); American Diabetes Association and Vault, “Insulin Affordability Survey, 2018,” May 22, 2018, http://main.diabetes.org/dorg/PDFs/2018-insulin-affordability-survey.pdf (accessed September 1, 2021), pp. 8, 16 (finding that 26 percent of respondents regularly took less insulin than prescribed in the past year because of the cost). See also T1International, “2018 T1International Out-of-Pocket Cost Survey,” 2018, https://www.t1international.com/access-survey/ (accessed September 1, 2021). For more information on the potential health impacts of rationing, see, for example, The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (accessed September 1, 2021) (“One study indicates that improved adherence among people with diabetes could prevent nearly 700 000 emergency department visits, 341 00 hospitalizations and save $4.7 billion annually”), p. 6.

[156] In addition to the income-based limitations discussed in greater detail below, the common requirement limiting aid from these patient assistance programs to US citizens and permanent residents also has the de facto effect of excluding certain documented and undocumented immigrants, many of whom come from communities where diabetes is especially prevalent. See Centers for Disease Control and Prevention, “National Diabetes Statistics Report, Estimates of Diabetes and Its Burden in the United States,” 2020, https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf (accessed September 1, 2021), p. 16 (documenting the higher prevalence of diabetes among different racial and ethnic communities in the US). Undocumented immigrants, who are largely excluded from federally funded public assistance programs like Medicaid, are already more than four-times more likely to be uninsured than US citizens and are accordingly especially vulnerable to insulin costs. “Health Coverage of Immigrants,” Kaiser Family Foundation, July 15, 2021, https://www.kff.org/racial-equity-and-health-policy/fact-sheet/health-coverage-of-immigrants/ (accessed September 1, 2021). See also Martin J. Kyalwazi and Camila Hurtado, “The California Insulin Crisis Explained: A Primer on Insulin Pricing, Past Legislative Action, and the Path Forward,” California Initiative for Health Equity & Action (Cal-IHEA), June 2020, https://healthequity.berkeley.edu/sites/default/files/cal-ihea_insulin_affordability_policy_brief_final.pdf (accessed September 1, 2021).

[157] See Novo Nordisk, “Patient Assistance Program,” December 2020, https://www.novocare.com/diabetes-overview/let-us-help/pap.html (accessed September 1, 2021); Lilly Cares Foundation, “Check Your Eligibility,” https://www.lillycares.com/how-to-apply#check-eligibility (accessed September 1, 2021); and Sanofi, “Patient Assistance Connection,” https://www.sanofipatientconnection.com/ (accessed September 1, 2021). The Federal Poverty Level for a single-person household in 2021 was $12,880. US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation,” 2021 Poverty Guidelines,” https://aspe.hhs.gov/2017-poverty-guidelines (accessed September 1, 2021). As of August 1, 2021, Minnesota is the only state in the US that has passed legislation requiring these programs to amend their eligibility requirements and selection processes. Minnesota Board of Pharmacy, “Minnesota Insulin Safety Net Program,” https://mn.gov/boards/pharmacy/insulinsafetynetprogram/ (accessed September 1, 2021). However, in a letter to Human Rights Watch, Novo Nordisk wrote that the restrictions on health insurance coverage were a major filter for many seeking assistance through their programs. See Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 2-3 (“Since January 2019, approximately 252,000 patients … have applied to the company’s PAP and approximately 218,000 patients … have been enrolled. While most applications are approved, the primary reason that patients are denied participation in the PAP is because the patient has insurance.”).

[158] See Department of Health and Human Services, Office of the Inspector General, “Pharmaceutical Manufacturer Copayment Coupons,” Special Advisory Bulletin, September 2014, https://www.oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf (accessed September 28, 2021) (interpreting the federal Anti-Kickback Statute to prohibit drug manufacturers from offering co-pay support through PAPs for prescriptions covered by public health plans (e.g., Medicare and Medicaid)). “There is no application or enrollment process (beyond the individual confirming he or she is over 18 years old, a U.S. resident, and not covered by a government insurance program.” Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 1. Each of the three insulin manufacturers included within this report also participate in Medicare Part D’s Senior Savings Model. Ibid., (“Nationally, approximately 50 percent of eligible seniors who use insulin enrolled in a participating plan. According to CMS, seniors who take insulin and enroll in a participating Senior Savings Model plan are expected to save an average of $446 in annual out-of-pocket costs for insulin—over 66 percent—with premiums increasing less than $1 per month.”); Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 3; and Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 8-9.

[159] Human Rights Watch telephone interview with Zoe Witt, May 12, 2021.

[160] See, for example, Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 7-8 (“In 2021, on average, it took approximately 3 business days for Sanofi’s vendor to process a completed PAP application. Patients receive their free medicine at their physician’s office approximately 4 business days after enrollment.”).

[161] Twitter Post, @mutualaidbetes, June 27, 2021, https://twitter.com/MutualAidBetes/status/1409350044398981120 (accessed September 1, 2021). Human Rights Watch text exchange with Zoe Witt, June 28, 2021.

[162] Both our letters to these manufacturers and their responses can be viewed in full in the Annex to this report. See, for example, Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 1 (“Today, anyone is eligible [under the Lilly Insulin Value Program] to purchase a monthly prescription of Lilly insulin for $35, whether they use commercial insurance, Medicare Part D, Medicaid, or have no insurance at all”); Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 2-3 (“In response to the COVID-19 pandemic and the effect that it has had on those living with diabetes, Novo Nordisk expanded its diabetes Patient Assistance Program … to offer a free 90-day supply of insulin to those who have lost health care coverage because of a change in job status due to the COVID-19 pandemic.”). Novo Nordisk’s Immediate Supply provides “a free, one-time, immediate supply of up to three vials.” Ibid. While helpful, this emergency stopgap protection is only available once per calendar year, and it is similarly unclear how many people have been able to take advantage of the program. Ibid. See also Novo Nordisk, “Immediate Supply offer terms and conditions,” https://www.novocare.com/content/novocare/en/eligibility/immediate-supply.html (accessed September 28, 2021). In a letter to Human Rights Watch, Sanofi also stated that the company “made a number of temporary changes to the Sanofi Patient Connection PAP to address documentation and product supply challenges in the early part of the COVID-19 pandemic,” and provide certain programs to individuals regardless of income level. Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 6-11.

[163] Ibid.

[164] US House of Representatives, Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf (accessed September 1, 2021). Please note that data for Canada is drawn exclusively from the province of Ontario, Canada. Ibid, pp. 3, 10-12. For information about these countries’ price-setting regimes, see, for example, Gross, Ratner, et al., “International Pharmaceutical Spending Controls: France, Germany, Sweden, and the United Kingdom,” Health Care Finance Review, Vol. 15(3), 1994, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4193451/ (accessed September 1, 2021); Rajkumar and Harousseau, “Next-generation multiple myeloma treatment: a pharmacoeconomic perspective,” Blood, Vol. 128(24), December 15, 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159700/ (accessed September 1, 2021); “What’s being done to bring down high drug costs?,” SwissInfo.CH, December 28, 2017, https://www.swissinfo.ch/eng/us---swiss-health-series_what-s-being-done-to-bring-down-high-drug-costs-/43785228 (accessed September 1, 2021); Boonen, Van der Geest, et al., “Pharmaceutical policy in the Netherlands: from price regulation towards managed competition,” Advances in Health Economics and Health Services Research, Vol.22, pp. 53-76, 2010, https://pubmed.ncbi.nlm.nih.gov/20575228/ (accessed September 1, 2021); Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 505-507; Kaiser and Ullrich, “Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark,” Journal of Health Economics, Vol. 36, pp. 174-187, July 2014, https://www.sciencedirect.com/science/article/abs/pii/S0167629614000460 (accessed September 1, 2021); “Regulatory, Pricing and Reimbursement,” Pharma Boardroom, October 22, 2018, https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-portugal/ (accessed September 1, 2021). For discussion of external or therapeutic reference pricing, therapeutic valuation, or health technology assessments, see, for example, Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 505-507 (discussing the different price mechanisms in UK, Australia, Germany, France, Ontario, Canada and Japan); Rajkumar and Harousseau, “Next-generation multiple myeloma treatment: a pharmacoeconomic perspective,” Blood, Vol. 128(24), December 15, 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159700/ (discussing countries with therapeutic value based price-setting mechanisms).

[165] For more information on the US Food and Drug Administration’s approval process, See US Food and Drug Administration, “Development & Approval Process, Drugs,” October 28, 2019, https://www.fda.gov/drugs/development-approval-process-drugs (accessed September 1, 2021). See, for example, Rajkumar and Harousseau, “Next-generation multiple myeloma treatment: a pharmacoeconomic perspective,” Blood, Vol. 128(24), December 15, 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159700/ (accessed September 1, 2021) (“In many European countries, Canada, and Australia, regulatory approval is only the first step. The price of the drug is then subject to negotiation based on the value it provides. […] In the United States, there is no system to define fair price.”).

[166] Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), p. 505 (“Unlike the United States, most industrialized countries do not rely primarily on market forces to control drug prices. Instead, they employ various forms of rate setting and price regulations such as external or therapeutic reference pricing, therapeutic valuation, and health technology assessment.”).

[167] For a discussion of this dynamic, see, for example, US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), p. 5 (“a combination of factors contributed to consumers facing higher costs for insulin over the last 15 years. First and foremost, pharmaceutical manufacturers have complete control over setting the list price … for their products.”). See also Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 500 (citing Kang, DiStefano, Socal, and Anderson, “Using external reference pricing in Medicare Part D to reduce drug price differentials with other countries,” 2019, Health Affairs, Vol .38(5), pp. 804–811) (“The study also showed that the longer the branded drug remained on the market, the greater the price differential between the United States and these comparison countries. This widening of the price differential is because prices in the United States tend to go up following the drug launch, whereas prices in other countries tend to go down. Other industrialized countries have employed various mechanisms to control postlaunch drug prices, whereas the United States allows pharmaceutical companies to increase drug prices as much as they want based on the market situation throughout the drug life cycle.”).

[168] US House of Representatives, Ways and Means Committee, “A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices,” September 2019, https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf (accessed September 1, 2021), p. 20. However, the study also found that seven non-insulin medications used to treat Type 2 diabetes were priced 600 to 1,100 percent higher in the United States than abroad. Insulin medications tended to have price differentials close to the average U.S.- international price differential, but non-insulin diabetes medications had much higher prices compared to the international average. Ibid.

[169] See Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 505-507, p. 508 (“The US system does not seem to work effectively given that the prices in the other countries are typically much lower than US prices. The various industrialized countries have utilized many different approaches to determine drug prices, including external reference pricing, therapeutic reference pricing, and [health technology assessment]. However, in spite of adopting different mechanisms, the prices the various countries pay for a market basket of drugs are relatively similar, and the main variation seems to be the income of the country and not the mechanism for setting the payment rate.”).

[170] Ibid., pp. 500, 507 (citing Kang, DiStefano, Socal, and Anderson, “Using external reference pricing in Medicare Part D to reduce drug price differentials with other countries,” 2019, Health Affairs, Vol .38(5), pp. 804–811) (“Some countries paid higher prices for some drugs compared with the other countries; however, these countries paid lower prices for other drugs, which offset the higher prices. In almost all cases, the United States is the outlier, with considerably higher prices.”). 

[171] Ibid., p. 507. See also Mulcahy, Whaley, et al., “International Prescription Drug Price Comparisons Current Empirical Estimates and Comparisons with Previous Studies,” RAND Corporation Research Report, 2021, https://www.rand.org/pubs/research_reports/RR2956.html (accessed September 1, 2021). For additional discussion of how the lack of drug price regulations in the US may allow companies to generate comparatively greater revenue from the US market than international markets, see, for example, US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), p. 52 (“Sanofi understood the risk of its decision [to increase US list prices] and ‘went into 2013 with eyes wide open that the significant price increases planned would inflame [its] customers’ … However, it was seeking to make up for ‘shortfalls with Lantus demand generation and global profit shortfalls’ which it said, ‘put pressure on the US to continue with the price increases to cover gaps.’.”).

[172] United States Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” 2020, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL%201).pdf (accessed September 1, 2021), pp. 39, 67-69, 7 (“Rebates for insulins have increased exponentially since 2013. In July 2013, Sanofi offered rebates between 2% and 4% for preferred placement on CVS Caremark’s client’s commercial formulary. Five years later, in 2018, Sanofi rebates were as high as 56% for preferred formulary placement.”). See also Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), (“Novo Nordisk, Eli Lilly, and Sanofi have reported that rebates have grown rapidly in recent years—representing more than 40% of U.S. gross sales in some cases.”). Between 2006 and 2014, the average rebate for drugs in Medicare’s pharmaceutical program increased from 8.6 percent of the list price to 14.3 percent, pointing to a growing influence of rebates on the entire pharmaceutical sector. See Dusetzina, Conti et al., “Association of Prescription Drug Price Rebates in Medicare Part D With Patient Out-of-Pocket and Federal Spending,” JAMA Internal Medicine, Vol. 177(8), pp. 1185-1188, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5722464/ (accessed September 1, 2021).

[173] See US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), p. 5 (“These price increases appear to have been driven, in part, by tactics PBMs [Pharmacy Benefit Managers] employed in the early 2010s. At that time, PBMs began to more aggressively pit manufacturers against each other by implementing formulary exclusions in the insulin therapeutic class … this tactic appears to have been more effective in boosting the size of rebates than suppressing the upward march of [list] prices. As a result, pharmaceutical manufacturers continued to raise [list] prices aggressively—increases that were often closely timed with price changes made by competitors”), pp. 29, 34 (“A product’s formulary placement can also affect a patient’s out-of-pocket spending, as demonstrated by an internal Sanofi analysis of Part D formularies operated by CVS Caremark that found co-pays for Lantus could “range . . . from $236 (34% co-ins) to as high as $348 (50% co-ins)” depending on its formulary tier.”). See also Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1303-06; Congressional Diabetes Caucus, “Insulin: A Lifesaving Drug Too Often Out of Reach,” November 5, 2018, https://congress.gov/116/meeting/house/109502/documents/HHRG-116-IF02-20190402-SD001.pdf (accessed September 1, 2021), pp. 10, 16.

[174] Pharmacy Benefit Managers (PBM), one of the least visible actors in the pharmaceutical supply chain, help health insurance companies manage their operations in relation to prescription and over-the-counter drugs. This includes negotiating with drug manufacturers and pharmacies on behalf of the insurer, helping decide whether and how drugs should be covered in health plan formularies, and administering claims from pharmacies. As PBMs define whether and how prescription and over the counter drugs are covered by the insurance companies they represent, they have an extraordinary influence on the business practices of pharmaceutical manufacturers. See Bai, Sen, and Anderson, “Pharmacy Benefit Managers, Brand-Name Drug Prices, and Patient Cost Sharing,” Annals of Internal Medicine, Vol. 168(8), pp. 436-437, March 20, 2018, https://www.acpjournals.org/doi/10.7326/m17-2506 (accessed September 1, 2021); Soon, Ribero, Tyan and Van Nuys, “The Association Between Drug Rebates and List Prices,” White Paper, USC Schaeffer Center for Health Policy & Economics, February 11, 2020, https://healthpolicy.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ (accessed September 1, 2021); The Commonwealth Fund, “Pharmacy Benefit Managers and Their Role in Drug Spending,” April 22, 2019, https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug-spending (accessed September 1, 2021); US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 29-30. The PBM market in the US is highly concentrated, with recent studies estimating that just three PBMs serve approximately 80 percent of people in the US with health insurance. See Soon, Ribero, Tyan and Van Nuys, “The Association Between Drug Rebates and List Prices,” White Paper, USC Schaeffer Center for Health Policy & Economics, February 11, 2020, https://healthpolicy.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ (accessed September 1, 2021). Different studies cite different levels of market concentration, however. See, for example, Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1303 (“Nationally, PBMs administer the prescription medication benefit for more than 266 million Americans, and the three major PBMs (CVS Caremark, Express Scripts, and OptumRx) manage about 70% of all prescription claims.”); US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 29-30 .For information on formularies and tier pricing, see Trisha Torrey, “What Is a Health Insurer's Drug Formulary and Tier Pricing?,” VeryWell Health, February 26, 2020, https://www.verywellhealth.com/drug-formulary-tiers-pricing-health-insurance-plans-2615042 (accessed September 1, 2021).

[175] Some studies suggest that PBMs may favor drugs that offer large rebates over similar drugs that may have much lower costs but lower rebates. See Soon, Ribero, Tyan and Van Nuys, “The Association Between Drug Rebates and List Prices,” White Paper, USC Schaeffer Center for Health Policy & Economics, February 11, 2020, https://healthpolicy.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ (accessed September 1, 2021); Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021); US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 29, 55; Dusetzina, Conti et al., “Association of Prescription Drug Price Rebates in Medicare Part D With Patient Out-of-Pocket and Federal Spending,” JAMA Internal Medicine, Vol. 177(8), pp. 1185-1188, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5722464/ (accessed September 1, 2021); Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), pp. 1305-06 (“The health plans the Working Group interviewed reported that plans and PBMs have an incentive to select medications for their formularies that offer a higher rebate.”).

[176] Manufacturers can lose access to large shares of the US market if their drug is excluded from or given restricted placement on these drug formularies that service millions of people on those insurance plans. As a result, manufacturers of similar types of drugs, such as analog insulin, compete to ensure that PBMs give their products beneficial placement. See US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), p. 5 (“drug manufacturers increased insulins’ [Wholesale Acquisition Cost] in part to give them room to offer larger rebates to PBMs and health insurers, all in the hopes that their product would receive preferred formulary placement. This pricing strategy translated into higher sales volumes and revenue for manufacturers. In some cases, manufacturers appear to have been concerned that decreasing WAC prices would be viewed negatively by PBMs, since PBMs capture a portion of rebate revenue and are also paid administrative fees based on a percentage of WAC.”). Ibid, Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 5 (“it has become increasingly common for insurers and PBMs to offer only one insulin manufacturer’s line of insulins on their formularies to achieve the greatest discount (rebate) and thereby the lowest cost. As a result, Lilly and other manufacturers aggressively compete for placement on insurers’ formularies and pay rebates to PBMs and insurers to keep medicines available on those formularies in crowded drug classes and, importantly, available to insureds. Overall, average Lilly discounts on U.S. list prices for our products have grown from 41% to 54% in the past five years, with rebates for our insulin products substantially above these rates.”), p. 79.

[177] See, for example, Soon, Ribero, Tyan and Van Nuys, “The Association Between Drug Rebates and List Prices,” White Paper, USC Schaeffer Center for Health Policy & Economics, February 11, 2020, https://healthpolicy.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ (accessed September 1, 2021).

[178] However, “There is considerable debate regarding how much the PBMs actually lower prices.” See, for example, Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), pp. 503 (“Understanding PBMs’ preferences for rebates, which are based on the difference between the list price and the actual net price, branded drug companies keep increasing their list prices and paying higher rebates. There is considerable debate regarding how much the PBMs actually lower prices. However, as noted at the beginning of this article, payers in the United States pay much higher prices than do those in other countries, and the price differential has grown larger over time”), p. 508 (“The drug supply chain in the United States promotes higher, not lower, prices.”).

[179] Soon, Ribero, Tyan and Van Nuys, “The Association Between Drug Rebates and List Prices,” White Paper, USC Schaeffer Center for Health Policy & Economics, February 11, 2020, https://healthpolicy.usc.edu/research/the-association-between-drug-rebates-and-list-prices/ (accessed September 1, 2021).

[180] See generally, US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021).

[181] Ibid., pp. 4-5, 6, 50-51.

[182] Ibid., pp. 6, 52-54. Internal company documents showed that both Eli Lilly and Sanofi also, at a minimum, “closely tracked and responded to price increases” from their competitors. For example, a 2014 email from an Eli Lilly official discussing potential price increases, published in the Committee report, notes that “Novo took a 9.9% price increase across their Insulin portfolio. Ibid., pp. 62-63.

[183] “This finding of greater increases in list prices than net prices raises the following questions. Who else has benefited or lost from the substantial increase in insulin list prices over the last decade? And why has the financial burden for people with diabetes who use insulin continued to increase—especially for those without insurance who may have to pay the full list price?” See Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1306 (citing Roland D, Loftus P., “Insulin prices soar while drugmakers’ share stays flat,” Wall Street Journal, 7 October 2016. https://www.wsj.com/articles/insulin-prices-soar-while-drugmakers-share-stays-flat-1475876764 (accessed September 1, 2021)), p. 1301 (“The Working Group found a number of examples from public sources showing that the net price to the insulin manufacturers has grown at a slower rate, or has gone down, compared to list prices. For example, the net price of the insulin formulation Lantus (glargine) increased more or less in parallel with the list price from 2007 to 2013. However, the net price has decreased in recent years (2014–2016). As a result, the net price increased by 57% between 2007 and 2016, increasing 23% as fast as the list price reported as a 252% increase over the same period.”). See also, Ibid., p.1301-1302 (“Bloomberg News reported an estimate by an independent market research firm that the list price of Eli Lilly’s human insulin analog, Humalog, increased by 138% between 2009 and 2015, while the net price to the manufacturer increased by 6%. Novo Nordisk also published data for two of their insulin products, NovoLog and NovoLog FlexPen. Since the early 2000s, th [compounding annual growth rate] for the list prices for NovoLog … have been in the range of 9.8–9.9%. This translated into large total increases in the list prices: 353% (2001–2016) for a NovoLog … In contrast, net prices received by the manufacturer increased at a more modest rate (3–36%) with [compounding annual growth rates] of 0.2–2.1%. Novo Nordisk, Eli Lilly, and Sanofi have reported that rebates have grown rapidly in recent years representing more than 40% of U.S. gross sales in some cases.”).

[184] Ibid., p. 1301.

[185] Sanofi’s letter to Human Rights Watch provided an updated figure for this for the period between 2012 and 2020. Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 11 (“the average net price for Sanofi’s insulins has declined by 53 percent between 2012 and 2020 … since 2012 the net price in commercial and Medicare Part D plans for our most prescribed insulin, Lantus, has fallen by 44.9 percent.”). Public data published by Eli Lilly also indicates that the list price for a vial of Humalog has been similarly stagnant; however, the net price figures used by Lilly aggregate net price values from Humalog and the self-authorized generic, insulin lispro. See Eli Lilly and Company, “2020 Environmental, Social, and Governance Report,” 2021, https://images.ctfassets.net/1o78rkhl3da6/4G7O4eiTriXm5PfSjs5qSR/9ca8946c735585fa759eb88a05c095b0/article-inline-image-humilog_price.png (accessed September 1, 2021).

[186] See, for example, Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 2-3; Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 4; Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 11; Eli Lilly and Company, “2020 Environmental, Social, and Governance Report, Access and Affordability,” https://esg.lilly.com/social#tab-control-tab1 (accessed September 1, 2021). See also “Testimony of Michael B. Mason, Senior Vice President, Connected Care and Insulins at Eli Lilly and Company, to United States House of Representatives, Committee on Energy and Commerce, Subcommittee on Oversight & Investigations,” April 10, 2019, https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Testimony-Mason%2004.10.2019.pdf (accessed September 1, 2021); “Testimony Of Douglas J. Langa, Novo Nordisk Inc., Before The U.S. House Of Representatives, Committee On Energy And Commerce, Subcommittee On Oversight And Investigations,” April 10, 2019, https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/‌files/documents/Testimony-%20Langa%2004.10.2019.pdf (accessed September 1, 2021); “Testimony of Kathleen W. Tregoning, Executive Vice President, External Affairs, Sanofi, Before the House Energy and Commerce Subcommittee on Oversight and Investigations,” April 10, 2019, https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Testimony-Tregoning%2004.10.2019.pdf (accessed September 1, 2021). See also US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), at: Appendix 2, https://www.finance.senate.gov/download/sanofi_redacted (accessed September 1, 2021), p. 23; Appendix 3, https://www.finance.senate.gov/download/novo_redacted (accessed September 1, 2021), p. 4; Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 5.

[187] Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 11 (Lantus’ “net price is lower today than it was in 2006”). Note that the 2021 Senate Finance Committee, analyzing data from 2016, found that each of these three manufacturers were retaining more revenue from the sale of insulin products than they were ten to fifteen years ago. Regarding Sanofi, the Senate Finance Committee found that the average net price for Lantus decreased by $32 between 2014 and 2016; however, the 2016 net price ($87.48) was still roughly twice the 2005 net price ($46.92). US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), pp. 4-5, 6, 50-51, 7, 45. Aside from the example cited below, Eli Lilly reported a steady increase in Humalog revenue for more than a decade, the Committee report states, from $1.5 billion in 2007 to more than $3 billion in 2018. Ibid., p. 7-8. Sanofi’s response to Human Rights Watch indicates that the per-vial rebate offered for Lantus products has likely increased in the five years since 2016; however, the company did not provide net price data that allowed us to independently verify this claim. Ibid.

[188] Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 11-12.

[189] CVS Health, OptumRx (owned by UnitedHealth Group), and Express Scripts (owned by Cigna). This correspondence, included responses from OptumRx and CVS Health, is reproduced in full in the Annex to this report.

[190] Letter from Heather Cianfrocco, Chief Executive Officer, OptumRx, to Human Rights Watch, September 20, 2021, pp 1-2. In its response to Human Rights Watch, CVS Health wrote: “CVS Health is committed to making prescription drugs, including insulin, as affordable as possible. Drug manufacturers alone are responsible for setting insulin list prices. To counter these high prices, CVS Health’s PBM offers our clients proven strategies to help diabetics access insulin at an affordable cost and prevent diabetes-related complications, including blindness, stroke, and renal failure.”). See Letter from Joshua Fredell, Vice President, Product Development, CVS Health, to Human Rights Watch, September 23, 2021, p. 1.

[191] A 2019 letter from Eli Lilly to the Senate Finance Committee investigation stated, “about 95% of patients filling prescriptions for Humalog […] at a retail pharmacy pay less than $100 and 90% of patients pay less than $50.” Almost 9 out of 10 patients who pay more than $100 to fill their Humalog prescription, the 2019 Eli Lilly letter stated, were patients on Medicare Part D plans that had high deductible or coverage gap phases. The rest of those shouldering high out-of-pocket costs, comprising roughly 6,000 people in their estimates, included approximately 1,600 likely uninsured patients on Humalog pay near the list price. US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 4, Fn. 5. See also Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1304 (describing how health insurers can distribute rebates to lower user costs). See also Letter from Heather Cianfrocco, Chief Executive Officer, OptumRx, to Human Rights Watch, September 20, 2021, p. 2 (“76% of our patients are paying zero or have $15 - $30 flat co-pays and virtually all of our Medicaid members pay $3 or less for insulin.”).

[192] See Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1302 (“This finding of greater increases in list prices than net prices raises the following questions. Who else has benefited or lost from the substantial increase in insulin list prices over the last decade? And why has the financial burden for people with diabetes who use insulin continued to increase especially for those without insurance who may have to pay the full list price?”).

[193] Also referred to as the Hatch-Waxman Act. Jeremy Greene, Kevin Riggs, “Why Is There No Generic Insulin? Historical Origins of a Modern Problem,” The New England Journal of Medicine, 2015, No. 372:12, https://www.nejm.org/doi/full/10.1056/NEJMms1411398 (accessed September 1, 2021), p. 1171. See also Aaron S. Kesselheim, “Determinants of Market Exclusivity for Prescription Drugs in the United States,” September 13, 2017, https://www.commonwealthfund.org/publications/journal-article/2017/sep/determinants-market-exclusivity-prescription-drugs-united (accessed September 1, 2021) (“In total, most brand-name drug manufacturers have a 12-to-16-year window during which their products are free from competition from lower-cost generics…. After discovering a new drug, manufacturers typically apply for a 20-year patent. However, after completing preclinical research and up to seven years of clinical trials, only part of this period remains. [Although the] drug manufacturers can extend the length of patent protection several ways.”); Patients for Affordable Drugs, “The Truth About Insulin Prices,” 2019, https://patientsforaffordabledrugs.org/wp-content/uploads/2019/11/The-Insulin-Report-Final-V.-1-1.pdf (accessed September 1, 2021), p. 3. During this period of market exclusivity, manufacturers have free rein to increase their list prices without generic competition, with the expectation that generic manufacturing will lower patient costs after patents expire. See, for example, Vincent S. Rajkumar, “The high cost of prescription drugs: causes and solutions,” Blood Cancer Journal, Vol. 10, 2020, https://www.nature.com/articles/s41408-020-0338-x.pdf (accessed September 1, 2021). These government-granted monopolies are meant to foster investment by drug companies into research and development by providing time for patent holders to recoup development costs. But the near-total lack of regulatory price transparency requirements has allowed pharmaceutical companies to benefit from this monopoly pricing without any obligation to reveal the research and development costs that they are ostensibly seeking to recoup. Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), p. 501 (discussing the purpose of patents); Wouters, McKee and Luyten, “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018,” Journal of the American Medical Association, March 3, 2020, https://jamanetwork.com/journals/jama/fullarticle/2762311 (accessed September 1, 2021) (discussing research and development costs, which can range from $314 million to $2.8 billion USD). Each of the three insulin manufacturers included within the scope of this report described ongoing research and development initiatives to improve diabetes patient outcomes. See, for example, Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 4-5. Similarly, Sanofi wrote that the company “spent approximately €5.5 billion globally on R&D” in 2020. Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 4. In a letter to Human Rights Watch, Eli Lilly wrote: “In 2020, Lilly invested 25 percent of its revenue into research and development, more than nearly every other company in the pharmaceutical industry. Over the last five years, Lilly has invested more than $25 billion into R&D, including $6 billion in 2020 alone to develop treatments for diabetes, cancer, Alzheimer’s, COVID-19, and other conditions.” Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 3.

[194] Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), p. 502.

[195] Ibid. See also Sanofi, “US Securities and Exchange Commission, Form 20-F,” 2019, https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/common/docs/investors/2020_03_23_Sanofi-Report-2019-20F-accessible.pdf (accessed September 1, 2021), p. 8 (““[A]n expiration of effective intellectual property protections for our products typically results in the market entry of one or more lower-priced generic competitors, often leading to a rapid and significant decline in revenues on those products”); Eli Lilly and Company, “Securities and Exchange Commission, Form 10-K,” 2020, https://investor.lilly.com/static-files/01da2e96-912a-4580-970a-4a0b455f9838 (accessed September 1, 2021), p. 25 (“loss of exclusivity […] typically results in the entry of one or more generic competitors, leading to a rapid and severe decline in revenues, especially in the U.S.”); and Novo Nordisk, “Securities and Exchange Commission, Form 20-F,” 2020, https://sec.report/Document/0001628280-20-001021/ (accessed September 1, 2021), p.7 (“Novo Nordisk anticipates that the expiration of certain patents could impact sales within the coming years.”).

[196] US Food and Drug Administration, “Generic Competition and Drug Prices,” Center for Drug Evaluation and Research, 2017, https://www.fda.gov/about-fda/center-drug-evaluation-and-research/genericcompetition-and-drug-prices (accessed September 1, 2021).

[197] Ibid. When it comes to the price of generic drugs, the US is actually a positive outlier, with unbranded generics 16 percent cheaper than average when compared to other OECD countries. In 2018, unbranded generic drugs accounted for 84 percent of US prescription drugs by volume, but only 12 percent of prescription drug spending at manufacturer prices. In contrast, brand-name originator drugs accounted for only 11 percent by volume, but 82 percent of US drug spending. Mulcahy, Whaley, et al., “International Prescription Drug Price Comparisons Current Empirical Estimates and Comparisons with Previous Studies,” RAND Corporation Research Report, 2021, https://www.rand.org/pubs/research_reports/RR2956.html (accessed September 1, 2021), pp. xi, xv.

[198] See Colorado Department of law, “Prescription Insulin Drug Pricing Report,” November 2020, https://coag.gov/app/uploads/2020/11/Insulin-Report-102020.pdf (accessed December 1, 2021), p. 39 (“Many insulin products have received additional patents, exclusivities, and extensions, adding decades of protection and monopoly prices. Evergreening is a familiar tactic for best-selling insulin products: Eli Lilly’s Humalog added 17 years of protection; Novo Nordisk’s Novolog added 27 years of protection; Sanofi’s Lantus added 28 years of protection.”), p. 46-48 (“Manufacturers of biopharmaceutical insulin have successfully controlled the market and have thus far prevented many generics or biosimilars from entering the marketplace through the use of patents and tactics to extend their exclusivity period … many insulin products have received additional patents, exclusivities, and extensions, adding decades of protection and monopoly prices.”). See also I-MAK, “Overpatented, Overpriced Special Edition Lantus (insulin glargine),” 2018, http://www.i-mak.org/wp-content/uploads/2018/10/I-MAK-Lantus-Report-2018-10-30F.pdf (accessed September 1, 2021), p. 4; I-MAK, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving Ip Drug Prices,” 2018, http://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf (accessed September 1, 2021); Andrew Dunn, “Insulin drugmakers under scrutiny for pricing, patent practices,” BioPharma Dive, November 2, 2018, https://www.biopharmadive.com/news/insulin-drugmakers-under-scrutiny-for-pricing-patent-practices/541275/ (accessed September 1, 2021). Patents’ ability to limit generic entry is especially true for biologic drugs, such as insulin analogs, which require complex manufacturing techniques and may have numerous secondary patents protecting specific methods used in their production. See, for example, Warren Kaplan and Reed Beall, “Insulin Patent Profile,” Health Action International, Addressing the Challenge and Constraints of Insulin Sources and Supply, April 2016, https://www.researchgate.net/profile/Reed-Beall/publication/303785920_Insulin_Patent_Profile/links/5751ed8308ae17e65ec36d9a/Insulin-Patent-Profile.pdf (accessed September 1, 2021), pp. 9-10, 12; University of College London, Therapeutic Innovation Networks, “Differences between Biologics and Small Molecules,” https://www.ucl.ac.uk/therapeutic-innovation-networks/differences-between-biologics-and-small-molecules (accessed September 1, 2021); US Food and Drug Administration, “Biosimilar and Interchangeable Biologics: More Treatment Choices,” March 3, 2020, https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices (accessed September 1, 2021); Jeremy Greene, Kevin Riggs, “Why Is There No Generic Insulin? Historical Origins of a Modern Problem,” The New England Journal of Medicine, 2015, No. 372:12, https://www.nejm.org/doi/full/10.1056/NEJMms1411398 (accessed September 1, 2021), pp. 1171-1173; Dean Baker, “The Future of the Pharmaceutical Industry: Beyond Government-Granted Monopolies,” The Journal of Law, Medicine & Ethics, Vol. 49, 21 April 2021, https://www.cambridge.org/core/journals/journal-of-law-medicine-and-ethics/article/future-of-the-pharmaceutical-industry-beyond-governmentgranted-monopolies/EA8810BB435446B2FEFF76D130DD3E2C (accessed September 1, 2021). In a letter to Human Rights Watch, Novo Nordisk stated that it “has not taken legal action against other pharmaceutical companies relating to efforts to manufacture or market biosimilar versions of NovoLog.” Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 4. In a letter to Human Rights Watch, Sanofi wrote: “Sanofi does not enter into “pay for delay” or “reverse payment” agreements that prohibit generic drug or biosimilar development after the expiration of a patent. Sanofi has reached settlements in patent infringement cases, and these agreements have allowed the generic company to commercialize its product before the expiration of the branded product’s patent(s).” Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021. For its part, Eli Lilly states that that company “does not pay for delays” in public materials and has engaged in zero “settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period.” See Eli Lilly and Company, “2020 Environmental, Social, and Governance Report, Access and Affordability,” https://esg.lilly.com/transparency#tab-control-tab2 (accessed September 1, 2021).

[199] Aside from structural access issues relating to rebates, discussed further below, non-biosimilar generics of these analog insulins, also sometimes described as follow-on drugs, are not considered automatically interchangeable with the brand name version, meaning that pharmacists cannot substitute a prescription for a brand name analog insulin with a cheaper follow-on version without a new prescription. As such, the moderate cost saving potential of switching from one of these branded drugs to the follow-on version requires more steps, such as another visit to the doctor. However, in a positive development, the Food and Drug Administration approved the first-ever interchangeable biosimilar, Semglee, a generic version of Sanofi’s Lantus in July 2021. Because it is interchangeable, this biosimilar may have a larger positive impact on patient costs than Eli Lilly’s already available follow-on version of Lantus. But while the list price for this interchangeable biosimilar is about one-third of that for Lantus, it will still cost $98 per vial. Food and Drug Administration, “FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes,” News Release, July 28, 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes (accessed September 1, 2021); Bob Herman, “The $100 "generic" insulin,” Axios, July 30, 2021, https://www.axios.com/fda-biosimilar-insulin-viatris-semglee-interchangeable-d8ffac02-c4e7-4282-b087-1ea32e432c72.html (accessed September 1, 2021). See also John White and Jennifer Goldman, “Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability,” Journal of Pharmacy Technology, Vol. 35(1), pp. 25-35, September 28, 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313268/ (accessed September 1, 2021), p. 30, p. 33; US Department of Health and Human Services, Food and Drug Administration, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry,” May 2019, https://www.fda.gov/media/124907/download (accessed September 1, 2021); Robert King, “FDA finalizes guidance to spur biosimilar availability,” Modern Healthcare, May 10, 2019, https://www.modernhealthcare.com/operations/fda-finalizes-guidance-spur-biosimilar-availability (accessed September 1, 2021); Mariana Socal and Jeremy Greene, “Interchangeable Insulins — New Pathways for Safe, Effective, Affordable Diabetes Therapy,” The New England Journal of Medicine, Vol. 382(11), March 12, 2020, https://pubmed.ncbi.nlm.nih.gov/32160658/ (accessed September 1, 2021) (discussing the importance of adopting new interchangeability guidance to improve availability and access to insulin products); Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1307 (discussing formulary decisions and biosimilars); Amanda Brooks, “Generic Insulins Are on the Market — So Why Aren’t People Using Them?,” GoodRx, April 3, 2020, https://www.goodrx.com/blog/generic-insulins-see-low-fills-insulin-lispro-insulin-aspart/ (accessed September 1, 2021).

[200] John White and Jennifer Goldman, “Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability,” Journal of Pharmacy Technology, Vol. 35(1), pp. 25-35, September 28, 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313268/pdf/10.1177_8755122518802268.pdf (accessed September 1, 2021), pp. 25-26 (discussing the various follow-on products, including Basaglar and Admelog, available in 2019). Eli Lilly brought its generic version of Sanofi’s Lantus, Basaglar, to market under a court-ordered settlement agreement. See “Lilly and Sanofi Reach Settlement Agreement in U.S. Insulin Glargine Litigation,” Eli Lilly, September 28, 2015, https://investor.lilly.com/news-releases/news-release-details/lilly-and-sanofi-reach-settlement-agreement-us-insulin-glargine (accessed September 1, 2021). See also Timothy Aungst, “Lantus vs. Basaglar: Are They Really the Same Insulins?”, GoodRx, September 9, 2019, https://www.goodrx.com/blog/lantus-vs-basaglar-effectiveness-dosing-side-effects-cost/ (accessed September 1, 2021). Sanofi’s strategy with Lantus succeeded in scaring away other generic competitors, including one which had already received tentative FDA approval for their own biosimilar. See MAK, “Overpatented, Overpriced Special Edition Lantus (insulin glargine),” 2018, http://www.i-mak.org/wp-content/uploads/2018/10/I-MAK-Lantus-Report-2018-10-30F.pdf (accessed September 1, 2021), p. 4; Eric Sagonowsky, “Sanofi sues Mylan over Lantus patents, seeking to defend its top-selling drug,” Fierce Pharma, October 25, 2017, https://www.fiercepharma.com/legal/seeking-to-defend-key-sales-sanofi-sues-mylan-for-lantus-patent-infringement (accessed September 1, 2021). See also Warren Kaplan and Reed Beall, “Insulin Patent Profile,” Health Action International, Addressing the Challenge and Constraints of Insulin Sources and Supply, April 2016, https://www.researchgate.net/profile/Reed-Beall/publication/303785920_Insulin_Patent_Profile/links/5751ed8308ae17e65ec36d9a/Insulin-Patent-Profile.pdf (accessed September 1, 2021), p. 10. Notably, Eli Lilly did not engage in similar litigation when Sanofi brought a follow-on version of Humalog to market after its primary patent expired in 2014. Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 2. See also Eli Lilly and Company, “2020 Environmental, Social, and Governance Report, Access and Affordability,” https://esg.lilly.com/social#tab-control-tab1 (accessed September 1, 2021); Ibid.,” https://esg.lilly.com/social#tab-control-tab1 (accessed September 1, 2021).

[201] In 2020, the number of insulin treatment visits in the US broke down into the following percentages: biosimilar insulin (8.2 percent); human insulin (5.5 percent); and branded or self-authorized generic versions of analog insulin (86.3 percent). Sarkar, Heyward, Alexander and Kalyani, “Trends in Insulin Types and Devices Used by Adults With Type 2 Diabetes in the United States, 2016 to 2020,” Journal of the American Medical Association, Diabetes and Endocinology, October 12, 2021, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784811 (accessed December 1, 2021) (analyzing millions of outpatient physician-patient interactions between 2016 and 2020 and finding that “Analog insulin use predominated and accounted for more than 80% of total treatment visits across all years” while “The use of biosimilar insulin, which was first approved in 2015, increased from 2.6% in 2017 … to 8.2% in 2020.”). See also Zhai, Sarpatwari, and Kesselheim, “Why Are Biosimilars Not Living up to Their Promise in the US?”, AMA Journal of Ethics, August 2019, https://journalofethics.ama-assn.org/article/why-are-biosimilars-not-living-their-promise-us/2019-08 (accessed September 1, 2021) (examining the current landscape of the biosimilar market and tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars).

[202] Patients for Affordable Drugs, “The Truth About Insulin Prices,” 2019, https://patientsforaffordabledrugs.org/wp-content/uploads/2019/11/The-Insulin-Report-Final-V.-1-1.pdf (accessed September 1, 2021), pp. 3-4. There are nearly 1,200 of these authorized generics of different drugs approved for sale in the US. These generics offer a way for brand manufacturers to crowd out potential competition over drugs with expiring patents and can be quite profitable, returning $50 for every dollar invested on average, even while being cheaper than their branded counterparts. Jay Hancock and Sydney Lupkin, “Drugmakers Master Rolling Out Their Own Generics To Stifle Competition,” Kaiser Health News, August 5, 2019, https://khn.org/news/drugmakers-now-masters-at-rolling-out-their-own-generics-to-stifle-competition/ (accessed September 1, 2021); Cutting Edge Information, “Drug Industry Study Finds a 5,100% ROI for Implementing Authorized Generics Strategies,” December 4, 2015, https://www.globenewswire.com/news-release/2015/12/04/1180907/0/en/Drug-Industry-Study-Finds-a-5-100-ROI-for-Implementing-Authorized-Generics-Strategies.html) (accessed September 1, 2021). See also Sydney Lupkin and Jay Hancock, “Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale,” Kaiser Health News, February 7, 2019, https://khn.org/news/trump-administration-salutes-parade-of-generic-drug-approvals-but-hundreds-arent-for-sale/ (accessed September 1, 2021) (“The [FDA] has approved more than 1,600 generic drug applications since January 2017.… But more than 700, or about 43 percent, of those generics still weren’t on the market as of early January … Even more noteworthy: 36 percent of generics that would be the first to compete against a branded drug are not yet for sale.”). In addition to its authorized generic, discussed below, Novo Nordisk sells a non-branded form NovoLog at Walmart. See Letter from Jennifer Duck, Vice President, Public Affairs, Novo Nordisk Inc., to Human Rights Watch, September 20, 2021, p. 2 (“Novo Nordisk Inc. is also proud to have part-nered with WalMart for more than 20 years to make human insulin available via the ReliOn label at $25/vial; as well as the expansion of our partnership in 2021 through WalMart’s introduction of a short-acting analog insulin with ReliOn NovoLog®and ReliOn NovoLog®Mix.”).

[203] Generics are medications created to be the same as an already-marketed, branded drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Kang, Bai, et al., “Comparative Approaches to Drug Pricing,” Annual Review of Public Health, Vol. 41, pp. 499-512, April 2020, https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-040119-094305 (accessed September 1, 2021), p. 502 (describing generics). An authorized generic, by contrast, is a non-branded version of a branded drug, produced by the same manufacturer as the branded drug. See Jay Hancock and Sydney Lupkin, “Drugmakers Master Rolling Out Their Own Generics To Stifle Competition,” Kaiser Health News, August 5, 2019, https://khn.org/news/drugmakers-now-masters-at-rolling-out-their-own-generics-to-stifle-competition/ (accessed September 1, 2021). See also Vincent Rajkumar, “The High Cost of Insulin in the United States: An Urgent Call to Action,” Commentary, Mayo Clinic Proceedings, Vol. 95, pp. 22-28, https://www.mayoclinicproceedings.org/article/S0025-6196(19)31008-0/fulltext (accessed September 1, 2021). See also US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, Appendix 1, https://www.finance.senate.gov/imo/media/doc/Eli%20Lilly_Redacted%20v1.pdf (accessed September 1, 2021), p. 3 (“By introducing an authorized generic, we can provide a lower-priced insulin more quickly without disrupting access to branded Humalog.”).

[204] Human Rights Watch analysis of current retail price averages for 10 listed pharmacies on GoodRx for both “Novolog (Brand)” and “Insulin Aspart (Generic),” GoodRx, https://www.goodrx.com/novolog?dosage=10ml-of-100-units-ml&form=vial&label_override=Novolog&quantity=1&sort_type=popularity (accessed September 1, 2021).

[205] Ciara Linnane, “Eli Lilly to reduce list price of Insulin Lispro injection by an additional 40% from Jan. 1, restoring it to 2008 levels,” MarketWatch, September 28, 2021, https://www.marketwatch.com/story/eli-lilly-to-reduce-list-price-of-insulin-lispro-injection-by-an-additional-40-from-jan-1-restoring-it-to-2008-levels-2021-09-28 (accessed September 29, 2021).

[206] Amanda Brooks, “Generic Insulins Are on the Market — So Why Aren’t People Using Them?,” GoodRx, April 3, 2020, https://www.goodrx.com/blog/generic-insulins-see-low-fills-insulin-lispro-insulin-aspart/ (accessed September 1, 2021) (citing US Senate Offices of Elizabeth Warren and Richard Blumenthal, “Inaccessible Insulin: The Broken Promise of Eli Lilly’s Authorized Generic,” December 16, 2019, https://www.fdanews.com/ext/resources/files/2019/12-16-19-InaccessibleInsulinreport.pdf?1576536304 (accessed September 1, 2021)).  

[207] US Senate Offices of Elizabeth Warren and Richard Blumenthal, “Inaccessible Insulin: The Broken Promise of Eli Lilly’s Authorized Generic,” December 16, 2019, https://www.fdanews.com/ext/resources/files/2019/12-16-19-InaccessibleInsulinreport.pdf?1576536304 (accessed September 1, 2021), pp. 3-4 (methodology), p. 1 (findings).

[208] Amanda Brooks, “Generic Insulins Are on the Market — So Why Aren’t People Using Them?,” GoodRx, April 3, 2020, https://www.goodrx.com/blog/generic-insulins-see-low-fills-insulin-lispro-insulin-aspart/ (accessed September 1, 2021).

[209] Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 2.

[210] Ibid.

[211] See Amanda Brooks, “Generic Insulins Are on the Market — So Why Aren’t People Using Them?,” GoodRx, April 3, 2020, https://www.goodrx.com/blog/generic-insulins-see-low-fills-insulin-lispro-insulin-aspart/ (accessed September 1, 2021); Amanda Brooks, “3 Reasons Most People Still Fill for Expensive Brand Insulins, Even Though Affordable Options Are Available,” GoodRx, https://www.goodrx.com/blog/why-people-still-fill-for-brand-insulins/ (accessed September 1, 2021); Bram Sable-Smith, “How Much Difference Will Eli Lilly’s Half-Price Insulin Make?,” Kaiser Health News, March 12, 2019, https://khn.org/news/how-much-difference-will-eli-lillys-half-price-insulin-make/ (accessed September 1, 2021); Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1307 (discussing formulary decisions and biosimilars).

[212] Tori Marsh, “Viagra Generic Leads to Surge in Prescriptions,” GoodRx, May 1, 2018, https://www.goodrx.com/blog/viagra-generic-leads-to-surge-in-prescriptions/ (accessed September 1, 2021).

[213] This kind of rebate trap can occur when the intermediaries between a manufacturer and the consumer choose not to stock or cover the generic version of a drug so as to not jeopardize the substantial volume-based rebates or discounts they may receive for the name-brand version. For more discussion of this dynamic, please see Sydney Lupkin, “Secretive ‘Rebate Trap’ Keeps Generic Drugs For Diabetes And Other Ills Out Of Reach,” Kaiser Health News, January 18, 2019, https://khn.org/news/secretive-rebate-trap-keeps-generic-drugs-for-diabetes-and-other-ills-out-of-reach/ (accessed September 1, 2021) (discussing how rebates influence what are placed on formularies in the context of insulin generics); Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, Vol. 41(6) (accessed September 1, 2021), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (discussing how rebates may be stifling biosimilar adoption). For more information about formulary decision making, see US Senate Finance Committee, “Insulin: Examining the Factors Driving the Rising Cost of a Century Old Drug,” Staff Report, 2021, https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL).pdf (accessed September 1, 2021), p. 34.

[214] Letter from Shawn O’Neail, Vice President, Government Affairs, Eli Lilly and Company, to Human Rights Watch, September 20, 2021, p. 1. Human Rights Watch also wrote letters to three of the largest PBMs in the US at time of writing— CVS Health, OptumRx (owned by UnitedHealth Group), and Express Scripts (owned by Cigna)—requesting information and clarification regarding their practices. This correspondence, included responses from OptumRx and CVS Health, is reproduced in full in the Annex to this report. In a letter to Human Rights Watch, OptumRx wrote: “The list price of insulin, independently set by pharmaceutical manufactures, is too high for a 100-year-old drug that has seen no significant innovations for decades. For years, insulin manufacturers have used loopholes in the patent system to stifle competition and increase prices. For example, there is only one interchangeable, or “generic,” insulin product available in the U.S. We believe drug pricing reforms can lower prices while maintaining access to innovative products.”). See Letter from Heather Cianfrocco, Chief Executive Officer, OptumRx, to Human Rights Watch, September 20, 2021, pp 1-2. In its response to Human Rights Watch, CVS Health wrote: “CVS Health is committed to making prescription drugs, including insulin, as affordable as possible. Drug manufacturers alone are responsible for setting insulin list prices. To counter these high prices, CVS Health’s PBM offers our clients proven strategies to help diabetics access insulin at an affordable cost and prevent diabetes-related complications, including blindness, stroke, and renal failure.”). See Letter from Joshua Fredell, Vice President, Product Development, CVS Health, to Human Rights Watch, September 23, 2021, p. 1.

[215] See Office of the United Nations, High Commissioner for Human Rights and World Health Organization, “The Right to Health: Fact Sheet No. 31,” https://www.ohchr.org/documents/publications/factsheet31.pdf (accessed September 1, 2021), p. 3 (“The right to health contains entitlements [including] [a]ccess to essential medicines.”).

[216] UN Committee on Economic, Social and Cultural Rights, “General Comment No. 14, The Right to the Highest Attainable Standard of Health,” UN Doc. E/C.12/2000/4, August 11, 2000, https://www.refworld.org/pdfid/4538838d0.pdf (accessed September 1, 2021), para. 1.

[217] Universal Declaration of Human Rights (UDHR), adopted December 10, 1948, G.A. Res. 217A(III), U.N. Doc. A/810, https://www.un.org/sites/un2.un.org/files/udhr.pdf (accessed September 1, 2021), art. 25(1).

[218] The US signed the Covenant in 1977. International Covenant on Economic, Social and Cultural Rights (ICESCR), adopted December 16, 1966, G.A. Res. 2200A (XXI), 21 U.N. GAORR Supp. (No. 16) at 49, U.N. Doc. A/6316 (1966), 993 U.N.T.S. 3, entered into force January 3, 1976, https://www.ohchr.org/en/professionalinterest/pages/cescr.aspx (accessed September 1, 2021), arts. 11(1), 12(c)(d). 

[219] The Vienna Convention is widely viewed as being reflective of customary international law. Vienna Convention on the Law of Treaties adopted May 22, 1969, G.A. Res. 2166 (XXI), 2287 (XXII), 1155 U.N.T.S. 331, U.N. Doc, https://legal.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf (accessed September 1, 2021), Art. 18.

[220] UN Committee on Economic, Social and Cultural Rights, “General Comment No. 3, The Nature of States Parties Obligations,” UN Doc. E/1991/23, December 14, 1990, para. 10.

[221] UN Committee on Economic, Social and Cultural Rights, “The Maastricht Guidelines on Violations of Economic, Social and Cultural Rights,” U.N. Doc. E/C.12/2000/13, October 2, 2000, para. 18.

[222] UN Committee on Economic, Social and Cultural Rights, “General Comment No. 14, The Right to the Highest Attainable Standard of Health,” UN Doc. E/C.12/2000/4, August 11, 2000, https://www.refworld.org/pdfid/4538838d0.pdf (accessed September 1, 2021), para. 39.

[223] Ibid., para. 17.

[224] Ibid., paras. 12(b)(ii), 12(d).

[225] UN Committee on Economic, Social and Cultural Rights, “General Comment No. 24 on State obligations under the International Covenant on Economic, Social and Cultural Rights in the context of business activities,” 2017, https://www.refworld.org/docid/5beaecba4.html (accessed September 1, 2021), para. 24. See also UN Committee on Economic, Social and Cultural Rights, “General comment No. 25 (2020) on science and economic, social and cultural rights,” 2020, https://undocs.org/E/C.12/GC/25 (accessed September 1, 2021), para. 69.

[226] UN Committee on Economic, Social and Cultural Rights, “General comment No. 25 (2020) on science and economic, social and cultural rights,” 2020, https://undocs.org/E/C.12/GC/25 (accessed September 1, 2021), para. 70.

[227] UN Educational, Scientific and Cultural Organization (UNESCO), “The Right to Enjoy the Benefits of Scientific Progress and its Applications (Venice Statement),” 2009, https://unesdoc.unesco.org/ark:/48223/pf0000185558 (accessed September 1, 2021).

[228] Ibid., para. 10.

[229] UN Committee on Economic, Social and Cultural Rights, “General comment No. 25 (2020) on science and economic, social and cultural rights,” 2020, https://undocs.org/E/C.12/GC/25 (accessed September 1, 2021), para. 69.

[230] “Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, on access to medicines,” May 1, 2013, A/HRC/23/42, https://www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session23/A-HRC-23-42_en.pdf (accessed September 1, 2021). See also UN Committee on Economic, Social and Cultural Rights, “General Comment No. 14, The Right to the Highest Attainable Standard of Health,” UN Doc. E/C.12/2000/4, August 11, 2000, https://www.refworld.org/pdfid/4538838d0.pdf (accessed September 1, 2021), para. 43.

[231] See M. Purgato and C. Barbui, “What is the WHO essential medicines list?”, Epidemiology and Psychiatric Sciences, Vol. 21, pp. 342-345, July 30, 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6998134/ (accessed September 1, 2021).

[232] The World Health Organization is migrating pages on their website and this information was accessed through the WayBackMachine. World Health Organization, “Essential Medicines,” https://web.archive.org/web/20210211035430/http://www.who.int/topics/essential_medicines/en/ (accessed September 1, 2021).

[233] See World Health Organization, “WHO prioritizes access to diabetes and cancer treatments in new Essential Medicines Lists,” October 1, 2021, https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists (accessed October 8, 2021); T1International, “T1International Advocates Win: WHO Adds Long-Acting Insulin Analogues to EML,” 1 October 2021, https://www.t1international.com/blog/2021/10/01/T1International-WHO-Win/ (accessed October 8, 2021); World Health Organization, Health Technologies and Pharmaceuticals Programme, Regional Office for Europe, “Consideration of diabetes medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML),” 2019, https://www.euro.who.int/__data/assets/pdf_file/0009/436563/2019-EML-DiabetesMeds-eng.pdf (accessed September 1, 2021).

[234] Goldstein, Patel, Bland, et al., “Frequency of Sale and Reasons for Purchase of Over-the-Counter Insulin in the United States, Journal of the American Medical Association, Vol. 179(5), pp. 722-727, February 18, 2019, https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2724389 (accessed September 1, 2021).

[235] See Cefalu, Dawes, et al., “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” Diabetes Care, American Diabetes Association, June 2018, 41(6), pp. 1299-1311, https://care.diabetesjournals.org/content/41/6/1299 (accessed September 1, 2021), p. 1310; The Endocrine Society, “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The Journal of Clinical Endocrinology & Metabolism, 2021, https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/insulin-position-statement-jcem.pdf (accessed September 1, 2021), p. 4.

[236] The US signed the Covenant in 2009. Convention on the Rights of Persons with Disabilities (CRPD), adopted December 13, 2006, G.A. Res. 61/106, U.N. Doc. A/RES/61/106 (2007), 993 U.N.T.S. 3, entered into force May 3, 2008, https://treaties.un.org/doc/source/docs/A_RES_61_106-E.pdf (accessed October 13, 2021), art. 25.

[237] The Vienna Convention is widely viewed as being reflective of customary international law. Vienna Convention on the Law of Treaties adopted May 22, 1969, G.A. Res. 2166 (XXI), 2287 (XXII), 1155 U.N.T.S. 331, U.N. Doc. A/CONF.39/11/Add.2, entered into force January 27, 1980, https://legal.un.org/ilc/texts/instruments/english/conventions/1_1_1969.pdf (accessed September 1, 2021), art. 18.

[238] UN Committee on the Rights of Persons with Disabilities, “Communication No. 10/2013,” October 28, 2014, para. 6.3.

[239] See, for example, Social Security Administration, “Red Book: A Summary Guide To Employment Supports For People With Disabilities Under The Social Security Disability Insurance (Ssdi) And Supplemental Security Income (SSI) Programs,” https://www.ssa.gov/pubs/EN-64-030.pdf (accessed September 1, 2021), p. 5 (“To meet our definition of disability, you must not be able to engage in any substantial gainful activity (SGA) because of a medically-determinable physical or mental impairment(s) that is either: Expected to result in death [or] Has lasted or is expected to last for a continuous period of at least 12 months… We use the term “substantial gainful activity” to describe a level of work activity and earnings.”); American Diabetes Association, “Is Diabetes a Disability?”, https://www.diabetes.org/tools-support/know-your-rights/discrimination/is-diabetes-a-disability (accessed September 1, 2021).

[240] See “Diabetes in the Workplace and the ADA,” US Equal Employment Opportunities Commission, EEOC-NVTA-2013-4 (May 15, 2013) https://www.eeoc.gov/laws/guidance/diabetes-workplace-and-ada (accessed September 1, 2021).

[241] International Covenant on Civil and Political Rights (ICCPR), adopted December 16, 1966, G.A. Res. 2200A (XXI), entered into force 23 March 1976, ratified by the United States on June 8, 1992, https://www.ohchr.org/en/professionalinterest/pages/ccpr.aspx (accessed September 1, 2021), arts. 2, 26.

[242] International Convention on the Elimination of All Forms of Racial Discrimination (ICERD), adopted December 21, 1965, G.A. Res. 2106 (XX), 20 U.N. GAOR Supp. (No. 14) at 47, U.N. Doc. A/6014 (1966), entered into force January 4, 1969, ratified by the United States on October 21, 1994, https://www.ohchr.org/en/professionalinterest/pages/cerd.aspx (accessed September 1, 2021), art. 1; US Constitution, art. XIV.

[243] See Human Rights Watch, “Targeting Blacks: Drug Law Enforcement and Race in the United States,” May 2008, https://www.hrw.org/sites/default/files/reports/us0508_1.pdf (accessed September 1, 2021), pp. 56-58. See also Jody Feder, “Racial Profiling: Legal and Constitutional Issues,” Congressional Research Service, April 16, 2012, https://fas.org/sgp/crs/misc/RL31130.pdf, pp. 4-9 (summarizing caselaw). In certain other contexts—such as statutory claims of employment or housing discrimination under civil rights laws—practices and procedures that have a disparate impact on a racial group can also trigger liability under United States law. See Lawrence Rosenthal, “Saving Disparate Impact,” Cardozo Law Review, Vol. 34, 2013, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2045688 (accessed September 1, 2021).

[244] Under ICERD, racial discrimination is defined as “any distinction, exclusion, restriction or preference based on race, colour, descent, or national or ethnic origin which has the purpose or effect of nullifying or impairing the recognition, enjoyment or exercise, on an equal footing, of human rights and fundamental freedoms in the political, economic, social, cultural or any other field of public life.” ICERD, Part I, Article 1(1).

[245] UN Committee on the Elimination of Racial Discrimination (CERD), “Consideration of Reports Submitted by State Parties under Article 9 of the Convention: Concluding Observations, United States of America,” CERD/C/USA/CO/6, February 2008, http://www2.ohchr.org/english/bodies/cerd/docs/co/CERD-C-USA-CO-6.pdf (accessed September 1, 2021), para. 10.

[246] ICERD, Part I, Article 2(1)(a).

[247] Ibid. Article 5(e)(iv).

[248] The ICESCR does not exclude non-nationals from its protections, except to note that “[d]eveloping countries, with due regard to human rights and their national economy, may determine to what extent they would guarantee the economic rights recognized in the present Covenant to non-nationals.” ICESCR, Art. 2(3).

[249] Office of the High Commissioner for Human Rights, “UN Guiding Principles on Business and Human Rights, Implementing the United Nations ‘Protect, Respect, and Remedy’ Framework,” 2011, http://www.ohchr.org/Documents/Publications/GuidingPrinciplesBusinessHR_EN.pdf (accessed September 1, 2021). See also Letter from Adam Gluck, Senior Vice President, Corporate Affairs, Sanofi, to Human Rights Watch, September 24, 2021, p. 2 (“Sanofi’s senior executives expressly recognize that multinational healthcare companies have a concurrent duty and social responsibility—alongside states and governments—to protect and advance human rights in all of its business operations and public positions. With this goal in mind, Sanofi’s governance policies and practices adhere not only to national laws and regulations related to human rights, but also seek to implement the standards and principles established by leading international instruments on human rights, including the UN Guiding Principles for Businesses and Human Rights, the Universal Declaration of Human Rights, the Children’s Rights and Business Principles, the OECD Guidelines for Multinational Enterprises, and the 2008 Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, among others.”).

[250] Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises, “Guiding Principles on Business and Human Rights: Implementing the United Nations 'Protect, Respect and Remedy' Framework," UN document A/HRC/17/31, March 21, 2011, https://www.ohchr.org/Documents/Issues/Business/A-HRC-17-31_AEV.pdf (accessed September 1, 2021), principles 17, 18, 21. The UN Guiding Principles also call on businesses to externally communicate how they address their human rights impacts in “a form and frequency that … are accessible to its intended audiences.” Ibid., principle 21, p. 23.

[251] Ibid., principle 17(c).

[252] Ibid., principle 18.

[253] Ibid., principle 19. See also Ibid, p. 21.

[254] Paul Hunt, UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, “Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” https://www.who.int/medicines/areas/human_rights/A63_263.pdf (accessed September 1, 2021), para. 26.

[255] Ibid. See also Suerie Moon, “Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry,” Health and Human Rights, Vol. 15(1), June 2013, https://www.hhrjournal.org/2013/10/respecting-the-right-to-access-to-medicines-implications-of-the-un-guiding-principles-on-business-and-human-rights-for-the-pharmaceutical-industry/.

[256] Paul Hunt, UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, “Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” https://www.who.int/medicines/areas/human_rights/A63_263.pdf (accessed September 1, 2021), para. 46.

[257] Ibid., Annex, paras. 2, 5.

[258] Ibid., Annex, para. 33. See also Ibid., paras. 34-35 (“The same medicine, for example, may be priced and packaged differently for the private and public sectors within the same country.… The arrangements should extend to all medicines manufactured by the company, including those for non-communicable conditions, such as heart disease and diabetes.”).

[259] Ibid., Annex, paras. 6, 37.

[260] Suerie Moon, “Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry,” Health and Human Rights, Vol. 15(1), June 2013, https://www.hhrjournal.org/2013/10/respecting-the-right-to-access-to-medicines-implications-of-the-un-guiding-principles-on-business-and-human-rights-for-the-pharmaceutical-industry/ (accessed September 1, 2021) (citing P. Hunt, “Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Health, Paul Hunt, Annex: Mission to GlaxoSmithKline,” UN Doc. No. A/HRC/11/12/Add.2, 2009, http://www.who.int/medicines/areas/human_rights/A_HRC_11_12_Add_2.pdf (accessed September 1, 2021)).  

[261] Ibid.

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