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NIA statement on CMS Medicare coverage policy for approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s

On April 7, 2022, the U.S. Centers for Medicare & Medicaid Services (CMS) released its final National Coverage Determination (NCD) decision memorandum on Medicare coverage for approved monoclonal antibodies (mAbs) as a treatment of Alzheimer’s disease. CMS issued a two-track decision that differentiates Medicare coverage for mAbs based on whether they receive from the U. S. Food and Drug Administration (FDA) 1) accelerated approval based on surrogate endpoints, or 2) traditional approval based on clinical endpoints. The NCD is specific to mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia, consistent with the label for Aduhelm™, which is currently the sole FDA-approved anti-amyloid mAb.

Medicare will not cover mAbs directed against amyloid for the treatment of Alzheimer’s when provided outside of randomized controlled trials conducted under an FDA Investigational New Drug application (IND), CMS-approved studies, or studies supported by the NIH. Medicare would also not provide coverage when the trial is investigating the drug in a way that is not according to the current FDA label. Should the FDA update the label, CMS would reevaluate the coverage policy accordingly.

Medicare will cover mAbs as a class of immunotherapy drugs that target amyloid (or plaque) for the treatment of Alzheimer’s that receive traditional approval from the FDA under coverage with evidence development. CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved prospective comparative studies and research registries.

Any new drugs in this class that receive FDA traditional approval may be available in additional care settings that people with Medicare can use, such as an outpatient department or an infusion center. For drugs that receive an FDA accelerated approval, i.e., aducanumab/Aduhelm, Medicare will cover their use in clinical trials conducted under an IND or NIH-funded randomized clinical trials.

There are no restrictions on individuals or organizations that can submit a study for anti-amyloid mAbs that are coverable in CMS-approved studies as long as the criteria specified in the NCD — such as the capability to complete a trial successfully — are satisfied.

NIH did not provide direct support for the development of aducanumab, nor are there any current NIA-supported clinical trials of this drug. However, NIA did support basic science investigations behind the discovery of immunotherapies such as aducanumab, as well as translational research for next-generation immunotherapies. Additionally, the selection of participants for the aducanumab clinical trials hinged on amyloid PET imaging, a technology that would not exist without the publicly funded research conducted and supported by NIA.

This progress in understanding Alzheimer’s disease as well as related dementias reflect years of scientific discovery and momentum in this research more broadly. NIA is grateful for the many individuals who have participated in clinical trials that helped advance our knowledge, and we continue to emphasize the enormous importance of participating in research studies.

NIA-supported scientists will continue to identify and test new drug candidates, advance comprehensive models of care, develop new biomarker tests, explore disease risk and possible protective factors throughout the life course, examine disparities in dementia prevalence and care, and improve the understanding of the role of genetics and other disease mechanisms.

We are also committed to recruiting and retaining a broad range of clinical trial participants, including those from diverse communities, and to expand and diversify the Alzheimer’s and related dementias research workforce.

Richard J. Hodes, M.D., Director, National Institute on Aging, National Institutes of Health