The Food and Drug Administration recently granted fast-track approval to a new Alzheimer’s drug designed to slow the rate of cognitive decline for individuals in the early stages of the disease. Lecanemab, which will be sold under the brand name Leqembi, was developed jointly by Eisai
— the same two companies that developed its controversial predecessor Aduhelm — and will be priced at $26,500 per year.
Read: New Alzheimer’s drug appears to slow cognitive decline but is ‘not a breakthrough’ The question is whether Medicare will follow the same path with Leqembi as it did with Aduhelm. Leqembi has received a slightly warmer reception from the medical community than Aduhelm, because a large trial showed it actually slowed the progression of Alzheimer’s (a clinical benefit), as opposed to simply removing plaque from the brain (a surrogate end point). But, as in the case of its predecessor, Leqembi involves side effects, such as swelling and bleeding in the brain, which means patients must receive periodic brain scans after starting treatment. Read: Why the FDA didn’t grant an approval to Lilly’s Alzheimer’s drug In the case of Aduhelm, concern over whether the benefits of the drug outweighed the risks led the Centers for Medicare and Medicaid to extend coverage only for individuals participating in randomized clinical trials. The ruling applies not just to Aduhelm, but to all Alzheimer’s drugs that target amyloid and have not received full FDA approval. Leqembi falls under the umbrella on both counts. Hence, in the short run, Medicare is unlikely to extend coverage, and private insurers tend to take their lead from Medicare. In the longer run, Eisai and Biogen have now applied for FDA approval of Leqembi under the traditional pathway. With clearer assurance that Leqembi helps patients, Medicare could cover it for all eligible patients, perhaps imposing a require …