In an unexpected move, the Veterans Health Administration announced Monday that it will widely cover a new Alzheimer’s treatment, even as Medicare has decided to wait for additional data about the medicine before taking the same step.
The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to Eisai, which is partnering with Cambridge-based Biogen to market the treatment. About 80 percent to 90 percent of veterans who clear these hurdles may be eligible for the treatment, but the exact number is uncertain, according to an Eisai spokeswoman.
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The decision comes two months after the Food and Drug Administration approved the medicine based on clinical trials showing Leqembi moderately slows cognitive decline in people with mild cognitive impairment or early-stage disease. There are, however, some risks of swelling and bleeding in the brain that require monitoring.
The FDA endorsed the drug under a designation called accelerated approval. The agency typically grants such an approval when a drug that is designed to treat a serious disease has few alternatives, but also has an uncertain benefit. Significantly, accelerated approval requires companies to conduct another clinical trial of their medicines before full approval can be considered.
The FDA decision followed a searing controversy over an earlier Alzheimer’s treatment from Biogen, which produced data that some experts considered insufficient for approval. Meanwhile, Biogen and FDA officials maintained unusually close contacts to push the drug forward. And the FDA also told its advisory committee it would not consider a surrogate endpoint for approval, but did so anyway.
The episode tarnished the FDA and raised questions about its approval process, prompting a congressional investigation that yielded a scathing rebuke. As a result, the FDA took a more cautious approach toward Leqembi, especially since the drug has safety risks that caused a prominent physicians group to urge the FDA to hold an expert panel meeting before granting full approval.
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