On the basis of a coverage decision for anti-amyloid monoclonal antibodies recently issued by the US Centers for Medicare and Medicaid Services, Medicare will offer ‘coverage with evidence development’ to allow more information on the clinical benefits of these antibodies to be gathered. Here, we discuss the implications of this decision for future clinical trials and Alzheimer disease care.
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D.K. serves on a Data Safety Monitoring Board (DSMB) for the Dominantly Inherited Alzheimer Network (DIAN) study. He served on a data safety monitoring board for a tau therapeutic for Biogen but received no personal compensation. He is an investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals and the University of Southern California. He has served as a consultant for Roche, Samus Therapeutics, Magellan Health and Alzeca Biosciences but receives no personal compensation. He receives funding from the NIH. M.S. serves as a consultant for Eisai, Avenir, vTv, Biogen, BioXcel, Hoffman LaRoche, NovoNordisk, Novartis and Merck. She chairs the DSMB for the Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD), sponsored by the University of Colorado. She receives funding from the NIH. H.H.F. serves as a member of a DSMB/Data Monitoring Committee for Janssen Research and Development and the Roche/Banner Institute, for which he does not receive personal compensation. He receives grant funding through the University of California San Diego (UCSD) from Biohaven Pharmaceuticals, Annovis (QR Pharma), AC Immune, Vivoryon (Probiodrug) and LuMind Foundation and has service agreements for consulting through UCSanD with Novo Nordisk, Samus Therapeutics, Samumed, Tau Consortium & Rainwater Charitable Foundation and Axon Neurosciences, for which he does not receive personal compensation. He holds grant funding from the NIH and the Canadian Institutes of Health Research.
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Knopman, D., Sano, M. & Feldman, H.H. CMS coverage decision on anti-amyloid monoclonal antibodies for Alzheimer disease. Nat Rev Neurol (2022). https://doi.org/10.1038/s41582-022-00672-3