Veterans Affairs to Be First Major Insurer to Cover Alzheimer’s Drug Leqembi
Roughly 168,000 veterans receiving care have Alzheimer’s dementia
Eisai Co. ’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year.
Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.
An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.
Leqembi is the first anti-amyloid drug shown to slow decline from Alzheimer’s. Its potential side effects include brain bleeding and swelling; people taking blood thinners may be at a higher risk of suffering large brain bleeds, according to the VA.
Leqembi, which was co-developed with Biogen Inc., is expected to have relatively small sales unless Medicare officials modify a decision that denies routine coverage of anti-amyloid drugs. Government officials have said they need to see additional data before they will reconsider the coverage decision.
Many analysts expect that Medicare won’t revise its decision until the FDA grants full traditional approval to Leqembi. The drug was approved in January using accelerated approval, which allows for drugs to be marketed before they are fully proven effective, based on its impact on biological markers of disease such as amyloid.
The FDA has set a deadline of July 6 to make a decision on full approval.
An earlier anti-amyloid drug developed by Biogen and Eisai, Aduhelm, was denied coverage by the VA in 2021. The agency cited the drug’s risk of side effects and a lack of certainty about its effectiveness.
Debate has raged for two decades over the role that amyloid plays in Alzheimer’s and its utility as a target for drug development. Scientists agree that amyloid is a defining characteristic of Alzheimer’s, but not on whether it is the root biological cause of the gradual decline in memory and day-to-day functioning.
However, some former skeptics have become persuaded that removing amyloid plaques with monoclonal antibody drugs can produce a benefit to patients, albeit a relatively small one that carries safety risks including brain swelling and bleeding.
Eisai and Biogen’s drug Leqembi slowed cognitive decline by 27% in a large study after removing large amounts of plaques. Eli Lilly & Co.’s drug donanemab dramatically lowered plaques in a midstage study that was associated with a slowing of cognitive decline; results from a Phase 3 study are expected sometime this year.