27 September 2023 - An amyloid-directed monoclonal antibody, lecanemab-irmb (Leqembi), was approved by the US FDA on 6 July 2023, to treat Alzheimer disease with mild cognitive impairment or mild dementia.
In this Viewpoint, we assess how the design of the CMS registry could impact the ability of Medicare to evaluate whether monoclonal antibodies are reasonable and necessary in the Medicare population and help physicians understand when the drug is most beneficial to their patients.