ADA Issues Recommendations Designed to Fix Insulin Pricing, Accessibility Crisis

The American Diabetes Association (ADA) released a set of policy recommendations designed to spotlight the increasing difficulties patients with diabetes have affording insulin or gaining access to the life-saving medication through health insurance. The recommendations follow the findings of a working group that were presented to the Special Senate Committee on Aging earlier this month.

The cost of diabetes in the United States was $327 billion in 2017, a 26% jump from 2012. That figure includes $31 billion for medication, including $15 billion for insulin.

The public policy statement creates recommendations in 4 areas, including:

• Streamlining the biosimilar process
• Increasing pricing transparency throughout the insulin supply chain
• Lowering or removing patient cost-sharing for insulin
• Increasing access to healthcare coverage

Competition and Biosimilar Insulins: Earlier this month, the FDA published a list of medications no longer under patent protection that do not have generic or biosimilar alternatives. The list includes 1 type of insulin that is off-patent but for which there are no alternative versions available. The ADA recommends the FDA continue its push to encourage additional competition in biosimilars.

Insulin Supply Chain: There is a lack of transparency at every level of the supply chain, the ADA and others have noted. ADA Chief Medical Officer William T. Cefalu, MD, told the Senate committee earlier this month that the byzantine structure of pharmacy rebates and discounts hurt patients and consumers.

To that end, the ADA wants to know exactly how money passes through the supply chain and how much each player profits: manufacturers, wholesalers, pharmacy benefit managers (PBMs), health plans, and pharmacies. Without specific pricing information, solutions to the crisis can’t be created, the ADA said.

Health Plans: The ADA recommends that health plans and government programs like Medicare and Medicaid change prescription drug benefit designs so that insulins are not subject to a deductible or coinsurance. Providing diabetes medications with low or no cost-sharing has been shown to increase medication adherence and results in better long-term health outcomes, the ADA said. The ADA noted that many plans are moving toward a value-based insurance design, lowering or removing cost-sharing for high-value clinical services and medications.

In addition, the ADA supports HHS having the ability to negotiate prices for the Medicare Part D program—something President Donald Trump’s recently announced drug pricing proposal did not include. The ADA also recommends health plans and government programs be required to limit out-of-pocket spending for medications.

Continuity of Care: The ADA recommends all health plans and government healthcare programs be prohibited from removing medications from formularies or moving medications to a higher-priced formulary tier during the plan year, except when the FDA has safety concerns. This prohibition should apply regardless of whether the pharmacy benefit is managed by a third party, like a PBM. This practice is prohibited in Medicare Part D, and some states have implemented similar restrictions for state-regulated health plans. The ADA recommends this prohibition be applied to all health plans and government healthcare programs.

Formulary Development: The ADA recommends regulators, health plans and government programs ensure that any value-based insurance design is evidence-based and that it includes consumer cost-sharing protections, such as low copays and accessible exceptions processes. The ADA recommends continued assessment of value-based models within Medicaid and Medicare, as well as provision of industry guidance regarding the role of Medicaid best price requirements in outcomes or value-based health insurance design

Improving Access to Healthcare: Citing the success of the Affordable Care Act in reducing the number of people without insurance, the ADA called for an expansion of Medicaid across all states to include individuals earning less than 138% federal poverty line.

Transparency for Consumers: The ADA recommends that all plans give information in a consumer-friendly, clear way that plainly explains the costs patients will face. For example, instead of using percentages to explain copays, plans should communicate that information using fixed dollar amounts.

The ADA also recommends that information be provided in one’s native language, especially since some populations may be at a higher risk for complications from diabetes.