The Centers for Medicare & Medicaid Services (CMS) has declined to revise its coverage policies regarding Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease .
In April 2022, CMS issued decision that denies coverage of FDA-approved treatments that target amyloid unless the patient is enrolled in a clinical trial. After the coverage determination, the Alzheimer’s Association took issue with the decision, saying it restricted access to treatments available today as well as future therapies. The association argued that historically, CMS had not previously limited access to an FDA-approved drug for conditions such as cancer, heart disease and HIV/AIDS and that CMS’ role is to provide health care coverage not deciding instead of a doctor, what FDA-approved treatments are appropriate. In December 2022, the Alzheimer’s Association requested that CMS review its coverage after data showed that Eisai/Biogen’s second monoclonal antibody, Leqembi (lecanemab), improved cognitive decline in patients with Alzheimer’s disease.
In their Response to the Alzheimer’s Association’s request, CMS said “We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favourable. 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 policy to block access to these treatments eliminates people’s options, resulting in continued irreversible disease progression and contributes to greater health inequities,” Joanne Pike, the president and CEO of the Alzheimer’s Association, said in a statement.
- CMS statement: Response to Alzheimer’s Association’s Request to Reconsider the Final National Coverage Determination. Feb 22, 2023 https://www.cms.gov/newsroom/press-releases/cms-statement-response-alzheimers-associations-request-reconsider-final-national-coverage?fbclid=IwAR1iE1LtCsrUcZmcFPnJ7G_tUUu70lKJZ4sWFDyxnJUvJ6VrPI97stbVWgM [Accessed March 1, 2023]
- Alzheimer’s Association Calls on CMS to Reverse Its Decision to Severely Limit Access to FDA-Approved Alzheimer’s Disease Treatments. Dec 20, 2022. https://www.alz.org/news/2022/alzheimers-association-calls-on-cms-to-reverse-its [Accessed March 1, 2023]
- Alzheimer’s association statement: CMS continues to block people living with Alzheimer’s from access to safe and effective FDA-approved treatments. Feb 22, 2023. https://www.prnewswire.com/news-releases/alzheimers-association-statement-cms-continues-to-block-people-living-with-alzheimers-from-access-to-safe-and-effective-fda-approved-treatments-301753865.html [Accessed March 1, 2023]