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This Article is From Apr 13, 2022

Aduhelm Coverage Decision Won’t Govern All Fast-Track Approvals, U.S Official Says

Aduhelm Coverage Decision Won’t Govern All Fast-Track Approvals, U.S Official Says

Last week's decision to restrict Medicare coverage for Alzheimer's drugs that are fast-tracked through the Food and Drug Administration doesn't portend changes in other disease areas, a top government official said.

“Our recent decision should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” Lee Fleisher, chief medical officer for the Centers for Medicare and Medicaid Services, said at a conference on Tuesday.

Some biotech companies and investors had wondered whether the move to limit coverage for Biogen Inc.'s Aduhelm in Alzheimer's signaled a higher bar for winning Medicare reimbursement. Fleisher said the circumstances with Biogen's drug were unusual and other areas of medicine like cancer have more established links between the endpoints measured in trials and clinical benefits.

Read more: A new crop of Alzheimer's drugs try to avoid Aduhelm's fate

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