Aduhelm’s Medicare judgement day is almost here

If past CMS coverage decisions are a predictor, the agency’s draft National Coverage Determination for Aduhelm would authorize coverage by Medicare when used according to the FDA label and only require evidence development for off-label use. But the unique circumstances of Aduhelm’s approval make breaking form a real possibility.

Marking one of FDA’s most controversial decisions, Aduhelm aducanumab-avwa from  Biogen Inc. (NASDAQ:BIIB) was granted accelerated approval in June, based on a reduction in β-amyloid plaques to treat Alzheimer’s disease in patients with mild cognitive impairment or early dementia. ...