Medicare’s proposal that it will cover Alzheimer’s drugs such as Biogen’s embattled Aduhelm only in clinical trials could have a simple but difficult result for the pharmaceutical industry: chaos.
The draft decision released yesterday is a response to the June choice by the Food and Drug Administration to grant the medicine an accelerated approval, going against a committee of the FDA’s expert advisers. That sets up an unusual dynamic: Generally, Medicare, the government’s health benefit for people 65 and older, covers medicines once the FDA approves them. For some medicines, it is required to do so. But in this case, Medicare is trying to put a genie back in the bottle, requiring that Biogen and other drug makers do studies that were not required by the FDA before Medicare will agree to cover Alzheimer’s drugs.