10 Mar 2023

The immediate future of lecanemab could be decided this summer. Eisai and Biogen announced March 5 that the U.S. Food and Drug Administration has accepted Eisai's supplemental Biologics License Application for traditional approval, granting it priority review (press release). A four-month clock now ticks on the process, meaning the decision will come on, or before, July 6. The FDA plans to convene an advisory committee meeting to guide its response; the date for that has not been set. Any approval decision will be based on the Clarity Phase 3 dataset (Sep 2022 news; Dec 2022 conference news).

Lecanemab, now known as Leqembi, is already commercially available. It received accelerated approval January 6, based on its ability to clear amyloid from the brain (Jan 2023 news). For its rollout, Eisai selected Soleo Health, a nationwide network of specialty pharmacies based in Frisco, Texas, as the sole U.S. distributor. Soleo Health can either administer the treatment through one of its own infusion centers, or route the drug to doctors’ offices (press release). Eisai began shipping doses to Soleo in January. The first prescription was written January 23 and the first infusion took place the following week, according to CEO Ivan Cheung (Endpoints news).

So far, patients are either paying the $26,500 per year price tag out of pocket, or getting the drug through Eisai’s patient-assistance program. Because a prior decision by the Centers for Medicare and Medicaid Services restricts coverage for anti-amyloid antibodies to trial settings, few people are expected to fill prescriptions for the treatment for now (Apr 2022 news).

CMS has resisted calls from advocacy groups to loosen this restriction. However, the agency noted that if an antibody receives traditional FDA approval, it will immediately be covered for patients who enroll in a registry that tracks their disease, allowing for much broader usage (CMS statement). The Alzheimer’s Association has set up one such registry, ALZ-NET, which would allow participating physicians in the U.S. to prescribe lecanemab for their patients and have it covered, as long as they enter treatment, safety, and outcome data into the database (Aug 2022 conference news).—Madolyn Bowman Rogers