BioCentury
ARTICLE | Politics, Policy & Law

CMS under pressure to revise Alzheimer’s mAb coverage

Republican members of Congress, patient advocacy groups call for closer collaboration between CMS and FDA

February 9, 2022 11:52 PM UTC

CMS is coming under increasing pressure to modify its proposed national coverage decision for anti-amyloid mAbs, including Biogen’s Aduhelm. Congressional attention could be reflected in legislation coupled with reauthorization of FDA medical product user fees.

In separate letters released Wednesday, Republican members of the House of Representatives and patient advocacy groups suggested that in proposing to restrict coverage of Aduhelm aducanumab-avwa from Biogen Inc. (NASDAQ:BIIB), CMS usurped FDA’s authority. ...