CMS to Cover New Alzheimer’s Drugs with Real-World Data Registry Participation

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In a change from previous policy, the Centers for Medicare and Medicaid Services (CMS) will cover new Alzheimer’s drugs with one catch – the manufacturer must participate in a new real-world data (RWD) registry. Patients eligible for coverage must have mild cognitive impairment, be a Medicare Part B recipient, and be treated by a participating clinical team.

According to Joanne Walker, “CMS has already seen the benefits of collecting registry data to gather information on a newly approved treatment. When the FDA granted traditional approval transcatheter aortic valve replacement (TAVR), CMS made it necessary for clinicians and hospitals to participate in a registry to track patient outcomes. In their statement, CMS clarified they are working with multiple organizations to open their own registries to collect the required real-world data (RWD). Data will be submitted through a nationwide, CMS-facilitated portal and they have assured it will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA. Any patient outcome data collected will be made available to researchers for study and further analysis, to advance the knowledge on the use of these drugs in the real world.”

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(Source: The Evidence Base, June 8^th, 2023)