STAT+: Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’

“We have in the past and certainly expect that we will continue to cover accelerated approvals. This isn’t a referendum on any decisions that we might make in the future,”…

AUSTIN, Texas – Chiquita Brooks-LaSure, the head of Medicare, said on Thursday that the agency expects to keep covering drugs the Food and Drug Administration approves through its fast-track accelerated approval pathway — despite the agency’s recent decision to only cover Biogen’s controversial Alzhiemer’s drug, Aduhelm, when patients enroll in clinical trials, which she described as “very rare.”

“We have in the past and certainly expect that we will continue to cover accelerated approvals. This isn’t a referendum on any decisions that we might make in the future,” Brooks-LaSure said in response to a question from STAT during a conference hosted by the Association of Health Care Journalists.

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