Alzheimer’s disease is a devastating illness that affects millions of Americans and their families. The Centers for Medicare & Medicaid Services (CMS) is committed to helping people get timely access to treatments and improving care for people with Alzheimer’s disease and their families.
At this time, CMS is not reconsidering the national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable.
After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration. CMS’s letter to the Alzheimer’s Association outlines the key questions that need to be addressed for reconsideration. As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective. We are aware that additional publications may be forthcoming that include information relevant to the questions included in the current NCD. CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD, such as evidence that answers the Coverage with Evidence Development (CED) questions or approval by the FDA based upon evidence of clinical benefit.
If a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives traditional FDA approval, CMS will provide broader coverage using the framework we announced last year, under CED, on the same day. As noted in the NCD, coverage through CED includes registry-based studies that reflect real-world care. Registry-based studies could answer the CED questions and potentially provide greater access nationwide at more treatment sites, more rapidly, than any other coverage pathway. The CED could also help fill evidence gaps for patients who were vastly underrepresented in initial trials. CMS looks forward to discussing with patients, their families, and other stakeholders how registries could enable widespread access.
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