Bloomberg Law
Free Newsletter Sign Up
Login
BROWSE
Bloomberg Law
Welcome
Login
Advanced Search Go
Free Newsletter Sign Up

Aduhelm Coverage Decision Won’t Govern All Fast-Track Approvals

April 12, 2022, 8:14 PM

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 ...