The Centers for Medicare and Medicaid Services (CMS) released a final Medicare national coverage determination (NCD) April 7, for coverage of monoclonal antibodies directed against amyloid approved by the U.S. Food and Drug Administration (FDA) with an indicated use to treat Alzheimer’s disease (AD). CMS received more than 10,000 stakeholder comments and more than 250 peer-reviewed documents during the most recent public comment period, including from the American College of Radiology® (ACR®).
Under the final determination, Medicare will cover monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer's disease that receives traditional approval from the FDA under coverage with evidence development (CED). This requires that payment will only be made for these drugs if patients are enrolled in CMS-approved clinical studies, such as data collection through routine clinical practice or data registries. The final determination includes coverage criteria and requirements for CMS-approved studies.
The final NCD is specific to individuals who have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia with a confirmed presence of plaque on the brain. Monoclonal antibodies directed against amyloid for the treatment of AD provided outside of an FDA-approved randomized controlled trial, CMS-approved studies or studies supported by the NIH, are nationally not covered.
Additionally, for drugs the FDA has not determined to show a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials. Under this determination, CMS will support the FDA by covering the drug and any related services (including, in some cases, positron emission tomography (PET) scans if required by trial protocol) for people with Medicare who are participating in these trials.
For any CMS-approved study or NIH-supported trial that includes a beta amyloid PET scan as part of the protocol, it has been determined that these trials or studies also meet the CED requirements included in the Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease NCD (220.6.20).
CMS has released a fact sheet about this final coverage decision. The ACR will continue to monitor and analyze the impact of this determination on nuclear medicine and molecular imaging, as well as its relation to 220.6.20. For more information, please contact Alicia Blakey, ACR Principal Economic Policy Analyst.