The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).
Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of FDA officials due to the approval.
In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.