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Addressing insulin price spikes will require supply chain reform


 

REPORTING FROM A HOUSE ENERGY & COMMERCE SUBCOMMITTEE HEARING


William Cefalu, MD, chief scientific, medical, and mission officer at the American Diabetes Association, echoed comments from Dr. Powers about pricing and suggested that simply going after list price is not a complete solution.

“There is also no guarantee that if the list price drops there [will] be substantive changes throughout the supply chain,” Dr. Cefalu said, adding that there needs to be a move away from a system based on high list prices and rebates and toward a system that ensures that any negotiated rebate or discount will find its way to the patient at the pharmacy counter.

“That’s what is not happening now,” Dr. Cefalu added. “Unless you can control what happens downstream in the intermediaries and what happens to the patient, there is no guarantee that just dropping list prices ... is going to get the job done.”

Aaron Kowalski, PhD, chief mission officer of JDRF, an organization that funds research into type 1 diabetes, also called out insurers as a part of the problem.

“What we are seeing in the community is people being switched [from their prescribed insulin for nonmedical reasons] by their insurance companies, not by the choice of their physician or the patient, which is just not the right way to practice medicine.”

He relayed an anecdote about a woman who went from having her blood sugar well controlled to dealing with severe cases of hyperglycemia because of changes in the medical coverage of her insulin. It took 8 hours on the phone with the insurance company, not to mention countless hours spent by the physician, to get the situation corrected and to get the proper insulin covered.

“This is a broken part of the system,” Dr. Kowalski said.

Dr. Cefalu noted that data are needed on the medical impact of switching for nonmedical reasons, such as changes to insurance coverage.

Christel Marchand Aprigliano, chief executive officer of the Diabetes Patient Advocacy Coalition, also relayed an anecdote of a friend who had suffered medical consequences of nonmedical switching of his insulin and then having to deal with his insurer’s fail-first policy before they would cover his original, medically effective insulin.

“Insurance has been denied twice because they believe that insulins are interchangeable, which they aren’t,” she said.

Michael Burgess, MD, (R-Texas) asked rhetorically during the hearing whether it would make sense for payers to simply provide insulin at no cost to patients, given the cost of medical complications resulting from lack of proper use as a result of pricing likely is much higher than covering insulin completely.

While specific legislative proposals were not discussed during the hearing, one thing that the panelists agreed would help to clarify all the factors that are contributing to the pricing increases is clear, transparent information about the finances surrounding the insulin as the product moves through the supply chain.

The Food and Drug Administration is also doing its part. Although the agency was not a participant in the hearing, the agency’s commissioner, Scott Gottlieb, MD, released a statement on the same day as the hearing in which he touted efforts in the biosimilar space that could spur competition.

“Once an interchangeable insulin product is approved and available on the market, it can be substituted for the reference product at the pharmacy, potentially leading to increased access [to insulin] and lower costs for patients,” he said in the statement. “The FDA anticipates that biosimilar and interchangeable insulin products will bring the competition that’s needed to help [deliver] affordable treatment options to patients.”

Dr Gottlieb did not say when a biosimilar insulin might be available on the market.

The second hearing in this series has not been scheduled, but is expected to take place the week of April 8 and will feature representatives from three insulin manufacturers and other participants in the supply chain.

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