House Subcommittee Hears Insulin Concerns as FDA Advances Biosimilar Transition

As a House of Representatives subcommittee met Tuesday to hear from stakeholders affected by the rising costs of insulin, 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.

According to the FDA, insulins will be regulated as biologics in 2020; 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.

Those cost savings are desperately needed by patients with diabetes, where 1 in 4 patients are skipping doses or rationing their medication due to price, witnesses told the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.

“Regulatory systems and patent extensions restrict the introduction of more generics and biosimilars,” said Alvin C. Powers, MD, director of the Vanderbilt Diabetes Center and chief of the Vanderbilt Division of Diabetes, Endocrinology, and Metabolism, and testifying for the Endocrine Society,

The 1 in 4 statistic came from Kasia J. Lipska, MD, from the Yale-New Haven Hospital Center for Outcomes Research and Evaluation at the Yale University School of Medicine. 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 and Company’s insulin lispro (Humalog), Lipska noted that it cost $21 in 1996 but now costs more than $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—is still much higher than $21, she pointed out.

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

The fact that one-fourth of patients skip insulin doses was echoed by William T. Cefalu, MD, the chief scientific, medical and mission officer for the American Diabetes Association (ADA), who noted that rationing can lead to fatal or near-fatal complications.

Similar to other witnesses, Cefalu discussed the lack of transparency in the pharmacy supply chain, including pharmacy benefit managers (PBMs).

“If biosimilars were more like generics, we would have a lower price,” said Cefalu, who testified that the regulatory framework for development and approval of follow-on insulins is burdensome for manufacturers, and that prices for follow-on insulins are not likely to be reduced unless there are several biosimilars that can be substituted for the brand name analog insulin.

The FDA said Tuesday it expects that approval of the newer insulins will create competition and will provide affordable treatment options. It said it wants input at the public meeting from stakeholders and patients as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products.

The hearing also touched on the role of ending rebates in Medicare Part D as one possible way to lower what patients pay at the pharmacy counter, as proposed by HHS. Energy and Commerce Committee Chairman Frank Pallone Jr, D-New Jersey, said he had concerns about it, but Christel Marchand Aprigliano, MS, chief executive officer of the Diabetes Patient Advocacy Coalition, said her organization supports the idea.

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, one of many related to insulin or drug costs taking place on Capitol Hill recently, will continue next week when the subcommittee hears from PBM representatives.