The Centers for Medicare & Medicaid Services provided new information on how individuals can obtain Medicare coverage for drugs that may slow the progression of Alzheimer’s disease. Medicare will cover these drugs if they receive traditional approval from the Food and Drug Administration and if the collection of real-world information is supported in appropriate healthcare settings. This real-world evidence will help assess the drugs’ effectiveness for Medicare beneficiaries.
In order to enrol for Medicare coverage, individuals must be enrolled in Medicare, diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, and have a physician who participates in a registry with a clinical team and follow-up care. Medicare will cover and pay for drugs in the monoclonal antibody class directed against amyloid for Alzheimer’s disease treatment if they have traditional FDA approval. Providers will participate in a data submission effort, commonly referred to as a registry, to evaluate the drug’s appropriateness and necessity for the Medicare population.
The registry will be available nationwide on CMS’s website if any of these drugs receive traditional FDA approval. By using the registry, CMS aims to collect information that helps evaluate the suitability of treatment for the Medicare population and answer key questions outlined in the National Coverage Determination (NCD). The registry will capture relevant information such as clinician and patient demographics, clinical diagnosis, medication details, and test results.
The data submission portal will be user-friendly, with drop-down menus available whenever possible. There is no fee associated with using the registry, and more details regarding data entry time will be provided in the future. CMS is committed to balancing the need for information collection with ease of use, ensuring privacy protections in line with applicable laws and regulations like HIPAA.
The registry will enable CMS and researchers to conduct studies that deepen our understanding of how these drugs can potentially benefit individuals with Alzheimer’s disease. By leveraging real-world evidence, CMS aims to determine the drugs’ impact on health outcomes, identify associated benefits and harms, track changes over time, and enhance knowledge for the Medicare population.
In response to the Alzheimer's Association's request to reconsider the final National Coverage Determination (NCD) for FDA-approved monoclonal antibodies directed against amyloid, the Centers for Medicare & Medicaid Services (CMS) has released a statement. The CMS stated that the evidence submitted does not warrant a change in the NCD.
The CMS acknowledged that these monoclonal antibodies have a unique mechanism of action, but the decision to deny coverage remains unchanged. It further stated that the CMS needs to evaluate whether the medication is necessary based on safety and efficacy considerations.
The CMS noted that additional publications are forthcoming that may address the questions raised by the CMS. It is also reviewing the new evidence and will consider a re-evaluation that could change the NCD.