Drugmakers and patient advocacy groups are waging a campaign to cast Medicare officials as villains after the program limited coverage of a pricey new Alzheimer’s drug and demanded tougher criteria than the FDA to prove it works
for patients enrolled in ongoing clinical trials, effectively cutting off access to the first new Alzheimer’s drug in nearly two decades, which the Food and Drug Administration approved in June despite conflicting trial results. The preliminary decision applies not only to Aduhelm, but the whole class of similar drugs, many of which are in development.
While the various supporters of broader access have not yet coalesced around a single strategy, broad outlines of a plan are already becoming clear. “On the Hill, a lot of people care about Alzheimer's,” Vradenburg said. “There will be letters. There’ll be meetings. There’ll be everything we can muster to turn that decision around.”
It is rare but not unheard of for CMS to change trial participation requirements between a draft and final coverage decision. In 2019, CMS proposed requiring hospitals administering CAR-T therapies to track patients in observational studies. Hospitals complained it was too burdensome and CMS relented.CMS’ requirements for Aduhelm are even more burdensome, said John Dwyer, president of the Global Alzheimer's Platform Foundation.
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