ADA Gives Recommendations Improve Insulin Affordability, Includes Follow-On Products

Recently, the American Diabetes Association (ADA) released a set of policy recommendations to improve patient access to much-needed insulin and to lower the substantial cost to treat diabetes.

Among the ADA’s recommendations are the following:

Competition and follow-on insulins: In the United States, follow-on insulins are currently regulated as drugs and not as biosimilars (though the ADA’s materials refer to such products as “biosimilars”). Currently, the FDA has approved 3 follow-on insulins: Admelog, Basaglar, and Lusduna, of which only Admelog and Basaglar are currently available for purchase in the United States.

Recently, the FDA published a list of medications that have lapsed in patent protection and do not have follow-on alternatives. Included in the list is insulin lispro (Humalog). The ADA encourages the FDA to continue its efforts to spur competition within the insulin landscape, including increasing competition from follow-ons.

Insulin supply chain transparency: The ADA’s working group concluded after discussions with stakeholders that there is an innate lack of transparency throughout the insulin supply chain. Without clear information about insulin pricing and costs to patients, it is difficult to properly identify solutions. Given this fact, the ADA recommends increasing transparency throughout the full supply chain, from manufacturers, wholesalers, pharmacy benefit managers, health plans, and pharmacies.

Health plan design and patient cost-sharing: The ADA recommends that insulins should not be subject to a deductible or coinsurance, because these practices expose patients to high list prices and create barriers to access to medication. The ADA notes that many plans are moving toward a value-based insurance design, and providing diabetes medications with low or no cost-sharing has previously been shown to increase medication adherence and better long-term health outcomes.

Additionally, the ADA recommends that health plans and government programs be required to limit out-of-pocket spending. Specifically, in the Medicare Part D program, the ADA recommends an annual out-of-pocket limit that is equal to the catastrophic phase trigger in order to provide a financial safety net for patients with high drug costs.

Continuity of care: Due to formulary decisions directly impacting insured patients, the ADA recommends that all health plans and government healthcare programs be prohibited from removing medications from their formularies or moving drugs to a higher tier during the plan year (with the exception of cases in which the FDA calls into question the safety of the drug).

“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,” read the policy statement.