Aduhelm has already been infused into the first Alzheimer’s patients post-approval, but Medicare hasn’t readied any criteria for limiting eligibility. The FDA’s approval, which applied to Alzheimer’s patients broadly, didn’t take into account the clinical trial population, which included only people with mild disease.
The price, the massive number of eligible patients and the FDA’s unusually close relationship with Biogen in the review process will likely be raised in forthcoming investigations and, potentially, hearings, too.
