In a Viewpoint article, authors consider how a CMS registry could be used in evaluating “whether monoclonal antibodies are reasonable and necessary in the Medicare population and [helping] physicians understand when the drug is most beneficial to their patients.”
“The CMS registry provides advantages over other methods of collecting health outcomes data while expanding access to lecanemab,” the authors conclude. “To maximize the value of the CMS registry, we recommend additional steps to ensure high-quality evidence generation and enrollment of a large and diverse patient population. If steps are taken to ensure adequate data collection and facilitate widespread enrollment, the CMS registry along with other registries have the potential to generate representative real-world data on amyloid-directed monoclonal antibodies, ultimately allowing the CMS to assess whether these drugs are reasonable and necessary for a wide range of Medicare beneficiaries with Alzheimer disease.”