- AGS supports CMS’ decision to not reopen its NCD on monoclonal antibodies and appreciates CMS’ commitment to review any new evidence that becomes available, such as evidence of clinical benefit, that may lead CMS to reconsider the NCD. http://ow.ly/nExW50N6pS
New York (March 2, 2023) — The American Geriatrics Society (AGS) supports the decision from the Centers for Medicare and Medicaid Services (CMS) to not reconsider its prior national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD). We appreciate CMS’ commitment to expeditiously review any new evidence that comes 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.
CMS’ statement was issued in a response to a request from the Alzheimer’s Association that it reconsider its prior decision. That request followed the FDA approval of lecanemab for use in treating patients with mild cognitive impairment and mild dementia due to AD in January 2023. AGS wrote to the FDA in December 2022 about the lack of evidence on whether lecanemab meaningfully reduces progression of AD; we specifically noted our concern that it was unclear if the potential benefits would outweigh the potential harms.
For monoclonal antibodies approved on the FDA accelerated pathway, like aducanumab and lecanemab, Medicare coverage requires participation in a CMS-approved randomized, controlled trial and diversity in study populations. In its decision, CMS noted that for monoclonal antibodies directed against amyloid for the treatment of AD that receive traditional FDA approval, CMS will provide broader coverage using the framework announced last year.
The AGS recognizes the heavy toll of Alzheimer’s disease and other dementias on patients, caregivers, and their families and we appreciate CMS’s careful attention to evidence development in the NCD with a focus on ensuring that study populations reflect the diversity of Medicare beneficiaries who are living with AD.
About the American Geriatrics Society
Founded in 1942, the American Geriatrics Society (AGS) is a nationwide, not-for-profit society of geriatrics healthcare professionals dedicated to improving the health, independence, and quality of life of older people. Our 6,000+ members include geriatricians, geriatrics nurse practitioners, social workers, family practitioners, physician assistants, pharmacists, and internists who are pioneers in advanced-illness care for older individuals, with a focus on championing interprofessional teams, eliciting personal care goals, and treating older people as whole persons. AGS believes in a just society, one where we all are supported by and able to contribute to communities where ageism, ableism, classism, homophobia, racism, sexism, xenophobia, and other forms of bias and discrimination no longer impact healthcare access, quality, and outcomes for older adults and their caregivers. AGS advocates for policies and programs that support the health, independence, and quality of life of all of us as we age. https://www.americangeriatrics.org/.