ADA Issues Recommendations to Improve Insulin Access

Miriam E. Tucker

May 29, 2018

In a new policy statement, the American Diabetes Association (ADA) provides specific short- and long-term recommendations for improving insulin access and affordability.

The average list price of insulin nearly tripled between 2002 and 2013. The rising costs and lack of access for many with diabetes have become a political flashpoint. On May 8, the US Senate Special Committee on Aging held a hearing devoted to the topic. On the same day, the ADA published a white paper that includes advice for clinicians on how to help minimize out-of-pocket costs for patients.

The new statement, published online by the ADA, is a follow-up to the white paper and provides more specific public policy recommendations. It was written by Krista Maier, JD, Vice President of Public Policy and Strategic Alliances, and Meghan Riley, Vice President of Federal Government Affairs at the ADA.

Maier and Riley address four key areas: streamlining the biosimilar approval process, increasing pricing transparency throughout the insulin supply chain, reducing or removing patient cost-sharing for insulin, and increasing access to healthcare coverage for all people with diabetes. 

"As the price of insulin continues to rise, so do patient costs. Individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to serious short-term and long-term consequences," they write in the introduction.   

The reasons for the increased prices are not entirely clear but "are due in part to the complexity of the drug supply chain," Maier and Riley write.

"In order to solve this escalating problem of insulin affordability, there must be a better understanding of the transactions throughout the insulin supply chain, the impact each entity has on what people with diabetes pay for insulin, and the relative efficacy of therapeutic options."

Insulin-Specific Recommendations

The statement calls for more insight into the factors involved in setting the list price, the starting point for negotiations throughout the supply chain, and "how changing list prices impact supply chain entities and patients."

To that end, the ADA recommends "increased transparency throughout the full insulin supply chain," and outlines specific information regarding insulin pricing that should be provided by each of the respective players: manufacturers, wholesalers, pharmacy benefit managers (PBMs), health plans, and pharmacies.

The association also makes recommendations regarding competition and biosimilar insulins. To date three such follow-on biologics have been approved by the US Food and Drug Administration (FDA), of which two are currently available. Unlike generic drugs, which are typically priced at 50% to 80% less than the brand-name counterpart, follow-on insulins are listed at approximately 15% less than the original versions.

According to the authors, increasing available options could further lower costs. Thus, the association recommends "the FDA continue its efforts to encourage additional competition within the insulin landscape, including fostering biosimilar competition."

The association also calls upon both government and private health plans to make changes to prescription drug benefit plans to cover insulin without patient cost-sharing. "At minimum, we recommend insulins not be subject to a deductible nor co-insurance, since this exposes people with diabetes to high list prices...If cost-sharing is imposed for insulins, it should be a flat dollar amount, which can be more manageable and consistent for consumers."

In addition, when there are deductibles or co-insurance for insulins, "the ADA recommends all discounts negotiated amongst the various supply chain entities (manufacturers, pharmacies, PBMs) be incorporated into the calculation of patient costs, ensuring patients pay the lowest price available."

Improving Access and Affordability of All Medications

In more general recommendations covering all medications, ADA advises that both Medicare and commercial health plans be required to impose caps on out-of-pocket spending.

They also say health plans should be prohibited from removing medications from prescription drug formularies or moving medications to a higher tier during plan years, barring an FDA-announced safety issue. Moreover, formularies should be evidence-based and offer "a wide range of options within each therapeutic area."

In line with the original intent of the Affordable Care Act, the ADA statement calls for every US state to expand Medicaid eligibility to people earning less than 138% of the federal poverty level.

In addition, "states should take steps to maintain or improve upon existing consumer protections that ensure people with diabetes have meaningful access to adequate, affordable health insurance coverage," and ensure that consumers have easy access to all plan information, including in non-English versions. 

In their conclusion, Maier and Riley explain that the transparency goals should help achieve the cost-reduction aims.

"When more is known about the transactions throughout the supply chain, it is likely additional promising public policy proposals will emerge," they state.

"In the meantime, the ADA recommends policymakers take any steps necessary to ensure all people with diabetes have affordable access to insulin, regardless of where they live, whether they have insurance, and how much money they earn."

The statement authors are employees of the ADA.

ADA Public Policy Statement. Published online May 24, 2018. Full text

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