CMS decision kills Aduhelm prospects, opens door to next amyloid mAbs

CMS’s final coverage decision on amyloid mAbs for Alzheimer’s disease may be the death knell for Biogen’s Aduhelm, but it opens a door to broader coverage of the next therapies in line, assuming they receive full approval based on efficacy endpoints.

The biggest change from CMS’s proposed national coverage determination, in which it restricted coverage of the entire therapeutic class to CMS-approved randomized-controlled trials, is that amyloid mAbs that receive full FDA approval based on cognitive and functional benefits will be covered in a broader array of study types, including registry studies and those where data are collected during routine care...