The Veterans Health Administration (VHA) said it will widely cover an experimental $26,500-per-year Alzheimer’s drug, even though Medicare will not.
Leqembi will be made available to veterans living with early stages of Alzheimer’s disease who meet agency criteria as well as conditions on Leqembi’s label, according to an announcement Monday by the drug’s manufacturers Eisai and Biogen. The move makes the VHA the first major insurer to agree to pay for the drug since its approval.
The VHA, under the Department of Veterans Affairs, is the largest health system in the country.
Leqembi was approved earlier this year through the Food and Drug Administration’s (FDA) accelerated pathway based on data showing it could moderately slow cognitive decline by reducing levels of a protein called amyloid in the brains of people with early-stage Alzheimer’s.
The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer’s Association for unrestricted coverage late last month, saying that officials need to see more data.
The companies announced in September that the drug slowed cognitive decline by 27 percent compared to a placebo. While modest, the results were the first to show that reducing amyloid could benefit patients.
As an anti-amyloid drug, Leqembi targets clumps of amyloid plaque that build up in the brain. Reducing that plaque is thought to slow the progression of Alzheimer’s, but it is not a cure.
Anti-amyloid drugs also have been shown to produce serious side effects, and Eisai and Biogen said patients in the trial experienced brain swelling and bleeding.
Due to the drug’s high price and coverage restrictions, seniors are unlikely to be able to access the treatment until Medicare covers it. If the FDA fully approves the treatment, the Centers for Medicare and Medicaid Services said it would provide broader coverage on the same day.
The FDA has set a deadline of July 6 to make a decision on full approval. But even then, Medicare will only cover Leqembi and other medications in its class if patients are enrolled in a clinical trial.
The surprising announcement by the VHA comes after the disastrous rollout of Biogen and Eisai’s previous anti-amyloid drug, Aduhelm. The FDA approved Aduhelm in 2021, but both the Department of Veterans Affairs and Medicare declined to cover it because of safety and efficacy concerns.
A congressional investigation found that the FDA’s approval of Aduhelm was “rife with irregularities.” Aduhelm was granted fast-track approval despite serious concerns about its effectiveness, and against the advice of the FDA’s own outside advisory panel.