Leqembi Label Recommends Alzheimer’s Patient Registry: A Nod To Medicare Evidence Demands?

Labeling for Eisai Co., Ltd./Biogen, Inc.’s new Alzheimer’s drug Leqembi (lecanemab) encourages patient enrollment in the Alzheimer’s Association’s recently launched patient registry, known as Alz-Net, which could provide a framework for collecting the kind of evidence on a voluntary basis that Medicare is mandating in its coverage policy for Alzheimer’s drugs.

Leqembi was approved by the US Food and Drug Administration on 6 January using the agency’s accelerated pathway. It is expected to obtain a traditional approval in July, at which time Eisai hopes to persuade the Centers for Medicare and Medicaid Services to relax its coverage restrictions on the drug and others in its class