When Deidre Waxman’s out-of-pocket costs for two insulin prescriptions reached about $280 a month in 2016, she struggled to afford the diabetes drugs without dipping into her savings.
So she started using insulin that was past its expiration date, and got her husband to buy the medicine in Canada.
“I don’t use tons of insulin like other people do, so I’d have some left over, and instead of getting a whole new script, I would use the insulin out of date,” said Waxman, 70, a retired social worker in Brookline who was diagnosed with diabetes a decade ago. “Doctors wouldn’t like you to do that.”
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Waxman is one of many people rationing insulin because of its cost, according to a study published Monday. Some 1.3 million Americans ― 16.5 percent of all adults with diabetes who use insulin ― had to conserve the life-saving medicine last year by skipping doses, taking less than needed, or delaying buying the drug, according to the article in The Annals of Internal Medicine. The study by researchers from Harvard Medical School, the City University of New York’s Hunter College, and Public Citizen, a nonprofit advocacy group, is believed to be the first national estimate of how many insulin users cut corners to save money, putting their health at risk.
The century-old drug nearly tripled in price between 2002 and 2013, according to the American Diabetes Association, and has caused out-of-pocket spending for Medicare recipients to surge more recently. And the situation probably won’t improve for many Americans even though President Biden in August signed a bill capping insulin co-payments for Medicare recipients.
Researchers in the study analyzed data from the 2021 National Health Interview Survey by the federal government, which collected information from 29,482 adults in every state. The analysis found about 1.4 million adults with type 1 diabetes, 5.8 million adults with type 2 diabetes, and 400,000 with other types of diabetes used insulin, which can cost more than $1,000 a month.
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The study found that 18.6 percent of people with type 1 diabetes (for whom skipping insulin can quickly lead to diabetic coma and death) rationed insulin, compared with 15.8 percent of those with type 2 diabetes. Rationing was lower among those age 65 or older (11.2 percent) ― virtually all of whom are eligible for Medicare ― than among those under 65 (20.4 percent).
Dr. Adam Gaffney, the lead author and a pulmonary and critical care physician at Harvard Medical School and the Cambridge Health Alliance, said that just about every month he sees a patient at Cambridge Hospital or Everett Hospital suffering from diabetic ketoacidosis. That’s a life-threatening complication that occurs because the body doesn’t have enough insulin to allow blood sugar into cells for use as energy. Rationing is sometimes to blame.
“I have had patients who haven’t taken insulin because of the cost,” Gaffney said, “so, no, I was not surprised at the percentages, unfortunately.”
The findings could have implications for policy debates. The 2022 Inflation Reduction Act signed by Biden in August capped Medicare enrollees’ copays for insulin at $35 a month. The initial draft of the bill would have also capped insulin costs for people with private insurance. But congressional Republicans stripped that provision from the bill after the Senate parliamentarian ruled that it wouldn’t comply with the budget reconciliation process that Democrats used to pass the cap. As a result, neither the privately insured nor the uninsured have any protection from insulin costs.
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The study found that diabetic people with no insurance had the highest rate of rationing (29.2 percent) followed by those with private insurance (18.8 percent). Rationing rates were lower for those with public insurance, including 13.5 percent among people enrolled in Medicare.
“The whole thing is crazy,” Dr. Steffie Woolhandler, a co-author of the study, said of rationing insulin. Woolhandler, a distinguished professor at the City University of New York’s Hunter College, lecturer in medicine at Harvard, and research associate at Public Citizen, added, “Insulin should be free. People take it to save their lives.”
Three giant, multinational pharmaceutical companies control the vast majority of the global insulin market, which exceeded $20 billion last year: Sanofi, Eli Lilly, and Novo Nordisk.
In 2018, about 75 protesters picketed outside Sanofi’s Cambridge offices to protest the price of insulin. They included two mothers who tried to deliver the ashes of their two children, who they said died while rationing the drug. The demonstration was organized by the Right Care Alliance, a Brookline-based coalition of patients and health care workers in which Waxman is active.
On Monday, Sanofi said that “despite rhetoric about skyrocketing insulin prices,” the amount of money that the Paris-based drug firm receives from the sale of its insulin products after rebates and discounts has actually fallen for seven straight years.
Since 2012, the firm said, the “net price” for commercial and Medicare Part D plans of Sanofi’s most prescribed insulin, Lantus, has decreased by 62 percent while average out-of-pocket costs for patients with commercial insurance and Medicare have risen approximately 60 percent. Sanofi blamed the disparity on so-called pharmacy benefit managers ― middlemen such as CVS Health’s Caremark ― and on insurers for failing to pass on savings to patients.
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But JC Scott, the head of the Pharmaceutical Care Management Association, the primary lobbying group for PBMs, disagreed.
“Let’s be clear, only drug makers set prices for their drugs,” Scott said. “The claim that PBM rebates are somehow to blame for the prices drug manufacturers set is just not true.”
Insulin was discovered in 1921 by a scientific team at the University of Toronto. The scientists later sold the patent to the university for $1, saying the drug should be made readily available to the public.
So why has it become unaffordable for so many Americans?
Dr. Kevin Riggs, an internist affiliated with the Birmingham Veterans Affairs Medical Center in Alabama, attributed the high cost in part to “evergreening,” the practice of drug firms making modest improvements to their products to extend the life of their patents. The tweaks include changing the delivery system from vials and syringes to insulin pens and altering how the drug is manufactured.
“There are all these incremental improvements as you march through the 100-year history of insulin,” said Riggs, who wrote a 2015 article on the drug in the New England Journal of Medicine. “Some are legitimate. Some are a little bit questionable.”
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Total out-of-pocket spending by people with Medicare Part D for insulin products quadrupled between 2007 to 2020, increasing from $236 million to $1.03 billion, according to the Kaiser Family Foundation. The number of Medicare Part D enrollees using insulin doubled over that time, from 1.6 million to 3.3 million beneficiaries, which suggests that the increase in total spending wasn’t completely related to more people on Medicare using insulin.
Waxman, who sometimes used expired vials of insulin, also got her husband, a physicist, to buy the drug at a Safeway store in Calgary, Canada ― where she didn’t need a prescription ― when he was on business trips. It didn’t cost less out of pocket, she said, but she saved money in the long run by not using her Medicare Part D prescription drug plan. Doing so could have triggered a notorious coverage gap in the federal insurance program and caused Waxman’s drug bills to temporarily spike.
She stopped using expired insulin and buying the drug in Canada about a year ago when she retired from her job as a social worker for the Town of Brookline. Now she obtains her Medicare Part D drug coverage through the state Group Insurance Commission for state and municipal employees and doesn’t have to worry about a coverage gap under the new plan.
“Insulin is not my only drug,” she said. “It’s all the drugs you buy that get you into the coverage gap.”
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.