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Physicians, advocates testify to insulin rationing due to unpredictable, high pricing
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WASHINGTON — Diabetes stakeholders and patient advocates once again brought their concerns regarding rising insulin prices before Congress on Tuesday, seeking a solution for people with diabetes who struggle to afford a lifesaving medication and demanding accountability from an often-opaque drug supply system.
The U.S. House of Representatives Committee on Energy & Commerce’s Oversight and Investigations Subcommittee convened the hearing as part of a larger effort to examine the high costs of prescription drugs, according to Rep. Frank Pallone, D-NJ, chairman of the House committee. It is the first of a two-part hearing devoted to insulin prices; the subcommittee will hold a second hearing with members of the insulin supply chain next week.
“No one should suffer because the high price of insulin puts it out of reach,” Pallone said during the hearing. “Yet, that is exactly what is happening. We must find workable solutions to support the development of high-quality drugs and insulin innovations while also ensuring that no one living with diabetes is ever forced to put their life at risk by rationing their insulin because they cannot afford it.”
Most expensive chronic illness
Appearing before the subcommittee, a panel of diabetes stakeholders spoke of patients with diabetes who are often forced to ration or forego their insulin, which can have a list price of several hundred dollars before applying copays or patient assistance programs. At the same time, experts struggled to explain a complex web of drug pricing — including insulin manufacturers, pharmacy benefit managers, payers and pharmacies — that they say are behind an increase in insulin prices that has made diabetes the most expensive chronic illness in America, according to the American Diabetes Association.
“Insulin pricing is a major problem for all of our patients, and there is no end in sight,” Alvin C. Powers, MD, director of the Vanderbilt Diabetes Center and director of the division of diabetes, endocrinology and metabolism at Vanderbilt University Medical Center, told Endocrine Today. “It is very discouraging that, for a drug that has been around for so long and hasn’t changed very much, prices continue to escalate.”
As Endocrine Today previously reported, in the past decade, estimated inflation-adjusted spending for insulin per patient tripled, from $231.48 in 2002 to $736.09 in 2013, according to an analysis of individual and prescription-level data published in the April 2016 issue of JAMA; those data combined both human and analogue insulins. The mean price per milliliter of insulin increased by 197%, whereas the mean price of dipeptidyl peptidase-4 (DPP-4) inhibitors increased by 34% from 2006 to 2013, and the mean price of metformin decreased by 93% from 2002 to 2013. The 2013 insulin cost, the researchers noted, was greater than expenditures on all other antihyperglycemic drugs combined, which was estimated at $502.57 in 2013.
In an interview before the hearing, Powers, who testified on behalf of the Endocrine Society, said clinicians struggle to assist patients who must navigate a confusing system of drug costs and insulin copays, in part because the prescribing clinician cannot know how much a patient might ultimately pay out of pocket.
“If you’re sitting with a patient in the exam room and you are going to prescribe insulin, you don’t know how much that patient is going to pay for the insulin when they get to the pharmacy, because it is such a complex system of rebates and copays,” Powers said. “So you can’t have a discussion with the patient about how to get the right value, in terms of the impact of the insulin vs. the costs.”
Opaque pricing
In a statement before the committee, William T. Cefalu, MD, chief scientific, medical and information officer for the American Diabetes Association, noted that the ADA’s insulin access and affordability working group, convened in 2017, identified several issues influencing the high price of insulin, including a lack of transparency throughout the insulin supply chain and a complicated regulatory framework for developing so-called biosimilar insulins.
However, Cefalu said, even experts studying the matter struggle to explain exactly why the price of insulin remains so high.
“We have to understand the transactions throughout the supply chain,” Cefalu told Endocrine Today after the hearing. “We talked a lot about transparency, but until we understand what the real problem is, we won’t be able to come to a long-term solution. ...We need information ... to better understand the negotiations between the stakeholders,”
In November, the Endocrine Society released a position statement that more information about the factors driving cost increases for insulin is needed to effectively combat the trend of rising prices. The organization cited “complex interactions” among insulin manufacturers, pharmacies, health plans, PBMs and wholesalers, making it a challenge to determine where in the supply chain costs continue to rise.
Christel Marchand-Aprigliano, MS, CEO of the Diabetes Patient Advocacy Coalition, told Endocrine Today that copay cards and patient assistance programs are not enough to help American families affordably access the insulin analogues they need to stay alive.
In an interview before the hearing, Marchand-Aprigliano said swift and immediate commitment is needed from all actors in the insulin supply chain, including the government, insulin manufacturers, insurance plans, and PBMs, to eliminate a “secretive rebating process” that has caused insulin list prices to rise.
“This can be accomplished through the HHS's rebate reform proposal for Medicare Part D and widespread abolishment of rebates in commercial plans,” Marchand-Aprigliano said.
Rationing a vital drug
Kasia J. Lipska , MD, a clinical investigator with the Yale-New Haven Medical Center for Outcomes Research and Evaluation at Yale University, told the committee that insulin rationing in her clinic has become widespread as the price of insulin has nearly tripled.
“In our clinic in New Haven, one in four patients who were prescribed insulin reported that they rationed insulin because of its cost,” Lipska told Endocrine Today before the hearing. “This is putting patients’ health at serious risk. Why are they rationing? Because the costs of insulin have skyrocketed. A vial of Humalog insulin cost just under $21 when it first came on the market in 1996. It now costs $275. There is nothing different or new about the Humalog we have today. It is the exact same insulin. The only thing that’s changed is its price.”
Patient advocate Gail DeVore, a member of the board of directors for JDRF, said Tuesday that government and stakeholders must take action soon.
“Just as we all need air to breathe, every person on this earth requires insulin to survive,” DeVore, who has had type 1 diabetes for 47 years, said during the hearing. “The relief we need is right now. Not next week, not next year.” – by Regina Schaffer
Disclosures: Cefalu is chief scientific, medical and information officer for the American Diabetes Association. DeVore, Lipska, Marchand-Aprigliano and Powers report no relevant financial disclosures.