In its announcement, CMS noted that Medicare will cover Alzheimer’s drugs that have traditional FDA-approval and have undergone physician and clinical evaluation that is input into a registry, which it says is similar to the agency’s traditional approaches to coverage determination.
“Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format. …” the CMS press release states. “Researchers will have access to the information to conduct studies, furthering knowledge of how these drugs can potentially help people. CMS is working with multiple organizations that are getting ready to open their own registries. More information will be released as they come online.”
But the registry as a condition of coverage process, according to the Alzheimer’s Association, creates “an unnecessary barrier” to care.
“Registries are important tools to gather much needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of an FDA-approved treatment,” the Alzheimer’s Association statement reads. “We remain concerned that the requirement of clinicians to register and enter data will create unnecessary hurdles.”
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