Veterans Affairs campaign to cover expensive experimental Alzheimer’s drug

The Veterans Health Administration (VHA) has said it will broadly cover an experimental Alzheimer’s drug that costs $26,500 a year, even though Medicare will not.

Leqembi will be available to veterans with early-stage Alzheimer’s who meet the agency’s criteria as well as Leqembi’s label conditions, the drug’s makers, Eisai and Biogen, said in an announcement Monday. The move makes the VHA the first major insurance company to agree to pay for the drug since its approval.

The VHA, under the Department of Veterans Affairs, is the nation’s largest health care system.

Leqembi was approved earlier this year through the Food and Drug Administration’s (FDA) fast track, based on data showing that it can modestly slow cognitive decline by reducing levels of a protein called amyloid in people’s brains with early stage Alzheimer’s disease.

The Centers for Disease Control and Prevention rejected the Alzheimer’s Association’s request for unlimited coverage late last month, saying officials needed to see more data.

In September, the company announced that the drug slowed cognitive decline by 27 percent compared to a placebo. Although modest, the results were the first to show that reducing amyloid can benefit patients.

As an anti-amyloid drug, Leqembi targets the clumps of amyloid plaques that accumulate in the brain. Reducing this plaque is thought to slow the progression of Alzheimer’s disease, but it is not a cure.

Anti-amyloid drugs have also been shown to cause serious side effects, and Eisai and Biogen said patients in the study experienced brain swelling and bleeding.

Because of the drug’s high price and coverage limitations, seniors are unlikely to be able to access the treatment unless it is covered by Medicare. If the FDA fully approves the treatment, the Centers for Medicare and Medicaid Services said it would provide greater same-day coverage.

The FDA has set a deadline of July 6 to make a decision on full approval. But even then, Medicare will cover Leqembi and other drugs in its class only if patients participate in a clinical trial.

The surprising announcement by the VHA comes after the disastrous rollout of a previous anti-amyloid drug by Biogen and Eisai 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 Aduhelm’s FDA approval was “rife with irregularities.” Aduhelm received accelerated approval despite serious doubts about its effectiveness and against the recommendations of the FDA’s own external advisory panel.