As the price of insulin has doubled since 2012, Congressional Diabetes Caucus co-chairs Tom Reed (R-NY) and Diana DeGette (D-CO) on Thursday outlined 11 policy recommendations that they believe will help lower prices.
Part of those recommendations include encouraging the development of follow-on insulin products (more on why they’re follow-on insulin products and not yet biosimilars here
) by addressing patent extensions and allowing generic and biosimilar manufacturers to produce older, off-patent insulin formulations.
“Congress could direct the FDA to make exceptions or allow fast-track approval for certain biosimilar insulin formulations, if they meet certain quality and comparative effectiveness standards,” the report says.
Reed and DeGette also address the need to deal with pay-for-delay agreements between brand and generic manufacturers, whereby generic firms are paid to keep their products off the market.
“By enacting legislation outlawing such agreements, Congress could assist in encouraging additional generic manufacturers to produce older insulin formulations without interference by brand-name manufacturers,” the report says.
Other policy recommendations in the report include linking patient out-of-pocket costs to negotiated prices instead of list prices, using transparency legislation to require drugmakers to disclose how insulin prices are set, and requiring insulin makers, pharmacy benefit managers (PBMs) and health insurers to disclose the value and volume of rebates that they receive and share with others in the insulin supply chain.
“Rebates can be used to lower premiums for patients. Under the current drug pricing system, however, independent entities, including our offices, cannot verify that rebates are being used for this purpose. Congress could require drug plans in federal health insurance programs to disclose their use of rebates throughout the supply chain,” they wrote.
The use of value-based contracts was also proposed, and DeGette and Reed said lawmakers could direct the Centers for Medicare and Medicaid Services to pilot outcomes-based pricing arrangements in Medicare.
The policy recommendations come as paying for insulin out of pocket can cost more than $300 per vial, and since patients regularly use two or more vials a month, their monthly costs can quickly surpass $600, making this life-sustaining medication unaffordable for many.