Biogen (and a lot of other people) have been waiting to see what Medicare makes of their FDA-approved antibody therapy for Alzheimer’s, Aduhalem (aducanumab). Medicare is going to be a big driver of the spending on any Alzheimer’s drug, naturally, and normally an FDA approval would make Medicare’s approval for payment almost automatic. Not this time. I won’t recapitulate the entire story, but the approval of Aduhelm has been. . .controversial. And the launch of the drug has been a mess as well, with many insurance companies and hospitals saying that they won’t pay for it. So the Medicare decision is an even bigger deal than ever, because many organizations are going to take their own cue from it.

Yesterday the Centers for Medicare and Medicaid Services (CMS) finally announced their decision: they will not pay for Aduhelm outside of its use in a controlled clinical trial. I think that’s an excellent call, and I can recommend the full CMS document as a summary of the state of Alzheimer’s research and therapy. It goes into the reasons to believe that amyloid is an appropriate target for treating the disease, and it goes into the reasons to doubt that idea. “The role of A-beta as cause versus marker of disease remains controversial“, it concludes, and boy does it ever. It also notes that the therapeutic landscape is barren, and that existing medications “do not prevent, halt, or slow – let alone reverse – the disease“. That’s