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March 08, 2019

House Subcommittee Hears About Impact of Rising Insulin Prices

Allison Inserro
A House of Representatives subcommittee heard from stakeholders about the impact of the rising cost of insulin.
Sitting behind 5 vials of insulin, Colorado resident Gail deVore told a House of Representatives subcommittee Tuesday about how the price of insulin has skyrocketed since she was diagnosed as a child with type 1 diabetes in 1972.

Back then, she said, the monthly cost for 4 of those vials was $5. Now, the cash price for those 4 vials is $1400, and even with insurance, the impact is severe, she said.

“It is seriously doubtful that either of us will ever have the opportunity to retire,” deVore said of her and her husband during the hearing, held by the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.

The hearing is just 1 of many happening lately in Congress about the price of insulin and drug costs in general. Compared to others that she knows with diabetes—those with no insurance, for example—deVore considers herself lucky, because she said those 4 vials have a “reasonable” copay, even though the rapid-acting insulin she uses, insulin aspart (Fiasp), is not covered by her insurance. She said she pays $346.99 per vial cash and rations it by diluting it with another insulin, against medical advice.

Rationing and skipping doses is common by patients with diabetes, even though it can lead to fatal or near-fatal complications, witnesses said.

William T. Cefalu, MD, the chief scientific, medical and mission officer for the American Diabetes Association (ADA), referred often to the recommendations of an ADA working group, and said that greater transparency was needed all along the insulin supply chain.

“It is unclear precisely how the dollars flow and how much each intermediary profits,” he said. Those profits stem from rising list prices, which are set by drug manufacturers; rebates negotiated by pharmacy benefit managers (PBMs) rise as well, but they are not passed on to the patient.

Kasia J. Lipska, MD, from the Yale-New Haven Hospital Center for Outcomes Research and Evaluation at the Yale University School of Medicine, discussed how 25% of patients with diabetes resort to rationing. In a survey of 199 patients at the Yale Diabetes Center, rationing affected patients across all different prescription coverage plans as well as across most demographic factors, although those with incomes below $100,000 were more likely to ration insulin, she said.

Holding up a vial of Eli Lilly's insulin lispro (Humalog), Lipska noted that it cost $21 in 1996, but now costs over $270. “Eli Lilly has made a big deal about its authorized generic,” she said, referring to an announcement last month that the company would cut the list prices 50% for its own generic of the brand version. But that price—$137.50—she said, is still much higher than $21.

“I think we have a moral obligation to address this problem,” she said.

Also Tuesday, the FDA announced it will hold a public hearing May 13 about its plan to transition follow-on insulins to a regulatory pathway for biosimilars.

In 2020, insulins will be regulated as biologics; currently, insulins and a number of other therapies, like hormones, are regulated as drugs and follow-on products. Once insulins are regulated as biologics under section 7002(e) of the Biologics Price Competition and Innovation Act, it will be possible for developers to seek interchangeable designations for their subsequent-entry versions, which will allow for pharmacy-level substitution and the potential for cost savings.

Aaron J. Kowalski, PhD, the chief mission officer of the JDRF, said his organization believes that competition drives innovation and affordability. “We aren’t saying that insulin companies shouldn’t be profitable,” he said. "They're selling insulin abroad at much lower price. The question is how can we make that happen in the United States of America and make sure insulins are affordable?"

“Having generics or biosimilars come to the market is another way of having affordability,” he added.

The hearing will continue next week when it hears from PBM representatives.

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