On Tuesday, May 8, 2018, the Senate Special Committee on Aging held a hearing entitled, “Insulin Access and Affordability: The Rising Cost of Treatment,” focused on access to insulin, in addition to the rising cost of treatment for patients with diabetes. The bulk of the hearing centered around the cost of insulin, including a focused discussion on the role entities within the insulin supply chain play in the overall cost of the drug.
Opening Statements
Chairwoman Susan Collins opined that the rising cost of insulin is a “real problem” and referenced statistics that showed that patients are actually skipping doses of their insulin to avoid paying for more insulin. She mentioned the oft-heard idea that patients are seeking medications from foreign countries and purchasing their medication on the black market to avoid paying the higher “legitimate” prices. Such moves, she believes, call for Congress to take a “careful look” at what can be done to promote more generic access.
Ranking Member Bob Casey spoke more personably about his state, noting that diabetes alone costs Pennsylvania over $13 billion per year, in part due to the fact that the price for insulin has tripled since 2002. For his part, he urged Congress to take steps to strengthen the Affordable Care Act for patients so that they do not have to deal with “sky high” drug costs.
Panel Testimony
The panel included witnesses from a variety of backgrounds: William T. Cefalu, M.D., Chief Scientific, Medical and Mission Officer at the American Diabetes Association; Paul Grant, the father of a son with Type I Diabetes; Lois Ondik, a retiree with diabetes; and Jeremy Greene, M.D., Ph.D., Professor of Medicine and Interim Chair of the Department of the History of Medicine at Johns Hopkins University School of Medicine.
Dr. William Cefalu highlighted a resolution that was passed by the board of directors of the American Diabetes Association in 2016 that called on all entities in the insulin supply chain to increase transparency in pricing associated with the delivery of insulin and to ensure that no patient with diabetes is denied affordable access to insulin.
Paul Grant shared the story of his son who has Type I diabetes. He references a specific situation where Express Scripts have him a price of $1,489 for a 90-day prescription of Humalog. Instead of paying that price, Grant instead purchased the prescription from a pharmacy in Canada at a price of only $294.
Lois Ondik shared her experience as a patient with Type 2 Diabetes. She credited self-management programs for helping her lost thirteen pounds and lower her A1C levels, while stressing the idea that there needs to be increased access to such self-management programs that can help patients perhaps avoid paying for medications entirely.
Dr. Jeremy Greene mentioned that one in four diabetes patients have admitted to rationing their insulin due to increasing costs, and called on Congress to open a bipartisan investigation in to the issue. He also focused on the need for a generic market and highlighted a much greater focus on transparency than other witnesses.
“Evergreening” Drug Patents
Lawmakers on both sides of the aisle criticized the practice where manufacturers extend market exclusivity by seeking additional patents on variations of the original drug (i.e., new forms of release, new dosages, and new combinations or variations), a practice known as “evergreening.” Senators argued that the practice acts as a barrier toward the creation of a generic insulin market, thereby keeping prices artificially higher than otherwise would be.
Transparency in the Supply Chain
For her part, Senator Collins criticized the drug pricing dynamic of insulin as a “complex” one with no transparency, from the pharmacies to the PBMs to the insurers to the distributors and manufacturers. She stated that while all of those interested parties are benefitting from a lack of transparency, it is the uninsured patients and the patients with high deductibles who are punished.
Dr. Greene opined that Congress is the only one that can ensure a more transparent drug pricing system due to concerns about the effectiveness of states’ powers, while Dr. Cefalu noted that transparency alone is not likely to address cost concerns.
PBMs, Manufacturers in the Hot Seat
Committee Democrats took some time to criticize the role of drug manufacturers and PBMs when talking about the rising costs of insulin. Senator Richard Blumenthal, for example, believes that the rising of insulin prices is an anti-trust matter, that the price has risen “without any credible explanation.” Senator Joe Donnelly also criticized them, focusing on the “perverse” system of higher price, higher rebate, questioning members of the panel on how entities in the supply chain can be incentivized instead to keep prices lower.