VA to Cover the Alzheimer’s Drug Leqembi

The U.S. Veterans' Health Administration (VHA) will provide coverage for Eisai/Biogen’s Leqembi (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD), according to a statement from Eisai. Patient organizations, including the Alzheimer’s Association and the Global Alzheimer’s Platform Foundation, support the VHA’s decision.

“We applaud the VA for its decision to cover Leqembi for veterans in the early stages of Alzheimer’s disease. This is a much-deserved victory for the almost 168,000 veterans who have Alzheimer’s and receive services through the VA,” Global Alzheimer’s Platform Foundation President John Dwyer, said in a separate statement.

The VHA has list of requirements veterans need to meet, including MRI and PET scan and cognitive testing, for inclusion, as well as list of exclusions that could limit who can receive access. The guidelines would exclude anyone who has had a stroke or seizure within the last year, as well as those who have MRIs that show evidence of microhemmorrhages, aneurysms, lesions or tumors.

“While the Alzheimer’s Association does not agree with all elements of the VHA’s criteria for use, we commend the Biden Administration for this important action today on behalf of veterans living with Alzheimer’s and their families,” the Alzheimer’s Association said in a statement.

Both organizations call on the Centers for Medicare and Medicaid Services (CMS) to reconsider its coverage of Leqemebi. Last month, CMS indicated it won’t change its coverage policies regarding FDA-approved monoclonal antibodies directed against amyloid to treat patients with Alzheimer’s disease. In a final national coverage determination, CMS said there still isn’t enough evidence to consider changing its coverage.

CMS last year issued a national coverage determination (NCD) that indicated FDA-approved monoclonal antibodies to treat Alzheimer’s disease would be covered if they are approved through the standard review process and not through an accelerated approval. This decision was made to address coverage questions related to Eisai/Biogen’s Aduhelm (aducanumab). The FDA had approved the therapy in June 2021, even though an advisory committee in November 2020 recommended against approval. Controversy immediately surrounded Aduhelm because of mixed results from clinical trials and Biogen's pricing of the therapy, which the company eventually reduced by half.

“Each day CMS blocks access to treatment, more than 2,000 individuals aged 65 or older transition from mild dementia due to Alzheimer’s to a more advanced stage of the disease where they are no longer eligible. Treatments taken in the early stages of Alzheimer’s would allow people more time to participate in daily life, remain independent and make health care decisions for their future,” the Alzheimer’s Association said.

Earlier this month, the Institute for Clinical and Economic Review (ICER), in an updated evidence report, calculated a health-benefit price benchmark (HBPB) of between $8,900 and $21,500 per year, which is lower than the Leqembi’s wholesale acquisition cost of $26,500 a year. ICER analysts said that Leqembi would need a 66% to 19% discount from its wholesale acquisition cost to fall within commonly used cost-effectiveness thresholds.

Related: Updated ICER Analysis Shows Leqembi Still Not Cost-Effective

Just after receiving accelerated approval for Leqembi in January 2023, the companies submitted a supplemental biologics license application (sBLA) for full approval. The FDA has granted priority review and indicated it plans to hold an advisory committee meeting. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023

The application is based on data from the phase 3 confirmatory Clarity AD clinical trial. In this study, lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and also published in the Jan. 5, 2023, issue of The New England Journal of Medicine.