On a recent episode of the Dementia Matters podcast, host Nathaniel Chin, MD, gives an overview of the new Alzheimer’s treatment Leqembi (lecanemab), and highlights results from the second and third phases of its clinical trials. On January 6, 2023, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease.
In the episode, Chin explains what accelerated approval means. “It is not fully approved by the FDA,” he said. “So with this FDA approval, insurers like Medicare won’t pay for it unless you’re in a clinical trial. Medicare can always change its mind, but as of now, that has been the position since aducanemab’s approval. Now, private insurers could make their own decisions and certainly private individuals could pay for it out of pocket.”
In the next month or so, FDA will review fuller data about lecanemab and could change or update that decision, he said. Centers for Medicare and Medicaid Services (CMS) will also review and make decisions about coverage as more data about the drug is reviewed, he said.
The episode also offers information specifcially about the drug’s use, details monoclonal anitbodies and how they work and risks and possible side effects associated with them. In the next week, Dementia Matters will release an episode featuring an interview with Cynthia Carlsson, MD, MS, and Sterling Johnson, PhD, to further discuss lecanemab and the clinical trials’ results.
Related links:
Read the FDA’s news release regarding lecanemab’s accelerated approval on their website.
Subscribe and listen to Dementia Matters, and read transcripts of each episode on the Wisconsin ADRC website.