Alzheimer’s Patient Registry Raising Questions as Drug OK Nears

Medicare’s insistence on using a patient registry as a condition of its coverage of a new Alzheimer’s drug is raising concerns as the FDA nears approval of the drug.

The Centers for Medicare & Medicaid Services pledged to cover Eisai Co. and Biogen Inc.’s Leqembi once the Food and Drug Administration grants full traditional approval of the pricey treatment, which is expected by July 6. But many stakeholders have questions about the CMS registry that the agency is requiring patients and clinicians to participate in before it will cover the drug.

The CMS recently spelled out new details about ...