Delays in FDA's accelerated approval drugs cost US $18B

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, according to the FDA. Following the agency's approval, drugmakers are then instructed to perform confirmatory trials after the treatment hits the market. But these tests aren't always on track, the HHS said. 

"For a variety of reasons, sponsors do not always complete trials promptly," the Office of Inspector General said in a Sept. 29 news release. "This can result in drugs staying on the market — and being administered to patients — for years without the predicted clinical benefit being verified. And insurers — including Medicare and Medicaid — paying billions for treatments that are not verified to have clinical benefit."

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