Devices

18 Senators Want End to Accelerated Approval Pricing Model

A 3/8 letter from 18 Republican senators is urging HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments under FDA’s accelerated approval program (AAP) with potential harms of delayed confirmatory clinical trials. According to an HHS report (begins pg. 14), the agency has been tasked to work with CMS to help determine:

If targeted adjustments on payments for AAP drugs accelerate confirmatory trial completion?
Whether adjustments help provide timely information on the safety and effectiveness of AAP drugs on the market?
If adjustments facilitate earlier withdrawals of AAP drugs when appropriate?
Whether it will reduce Medicare spending on drugs that do not have confirmed clinical benefit?

However, the senators’ letter says the proposed pricing model will chill incentives for drug manufacturers to pursue accelerated approval for their products, which will result in delayed access for patients. Additionally, they argue that “inadequate reimbursement” could force physicians to shift patients toward higher-cost treatments.

The proposed model is in response to a 10/22022 Biden Administration Executive Order entitled “Lowering Prescription Drug Costs for Americans.” The pricing structure would be designed to “avoid penalizing physicians or beneficiaries for choosing (or avoiding) an accelerated approval treatment,” the report says. “By incentivizing timely confirmatory trial completion, CMS could enable improved access to post-market safety and efficacy data.”

FDA’s accelerated approval program has drawn increased scrutiny in the past few years, particularly over drug makers’ not being as diligent as they should be in completing confirmatory trials. Late last year, the program won FDA-sought legislative reforms in the omnibus spending bill (see earlier story).

The HHS report notes that as of 5/2022, 104 out of the 278 accelerated-approved drugs have incomplete confirmatory trials. “From 2018 to 2021, Medicare and Medicaid together spent an estimated $18 billion on AAP therapies that were past their originally scheduled confirmatory trial completion date,” it says. “Given the increasing number of AAP approvals, some experts are concerned the number of past-due trials may continue to increase.”

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