A Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that receive so-called accelerated approvals than for drugs that are granted traditional approvals.
The Food and Drug Administration uses accelerated approvals to make promising drugs for serious conditions available to patients sooner. The program is widely considered a success and has worked well for many drugs, including the leukemia drug Gleevec, which the FDA approved in 2001 after a review period of just two-and-a-half months, based on study results that correctly predicted successful clinical outcomes.
But not all drugs work out. Accelerated approvals were withdrawn for about 12% of drugs as of the end of 2021, according to an analysis by Amgen researchers, and that’s not a bad thing. FDA drug center official Peter Stein said some failure is inherent to the design of the accelerated approval program, though the agency has not set a target failure rate.
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