News Briefs: CMS Plans to Post List of Alzheimer’s Drug Registries for Physician Choosing

As the FDA prepares to make a full approval determination on Alzheimer’s drugs such as Biogen Inc.’s Leqembi (lecanemab-irmb), CMS has released new details about its plan to collect real-world data on Medicare patients taking the drugs. To qualify for Medicare coverage of a drug with traditional FDA approval that may slow the progression of Alzheimer’s disease, patients’ physicians will have to participate in the collection of evidence about how the drugs work in patients through a registry. And they will be able to submit that information in an “easy-to-use format” through a nationwide, CMS-facilitated portal, the agency explained last month. CMS is working with multiple organizations preparing to launch their own registries, and once available, those will be listed online and clinicians may choose a registry for participation, the agency clarified on June 22. CMS also listed the various elements it intends to capture through the registry, including information related to questions in the National Coverage Determination, such as whether the drug meaningfully improves health outcomes (i.e., slows the decline of cognition and function) for patients in broad community practice, and whether the benefits and harms (e.g., brain hemorrhage and edema) associated with the use of the drug depend on the characteristics of patients, treating clinicians and setting. The FDA decision is expected by July 6.

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