Becker's Healthcare October 3, 2022
After Aduhelm failed to gain Medicare coverage amid concerns about its efficacy — despite the FDA placing the Alzheimer’s drug on its accelerated approval pathway — an HHS report found the U.S. has spent more than $18 billion on these accelerated drugs from 2018 to 2021 with delays in confirmatory trials.
The HHS estimates that 18 drugs corresponding with 35 applications that are behind on confirmatory trials cost Medicare Part B and Part D about $14 billion, Medicare Part C $5.9 billion and Medicaid $3.6 billion.
The accelerated approval process is meant to propel life-saving drugs through the approval process faster,...
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