Association Files Formal Request for Reconsideration of National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
CHICAGO, December 20, 2022
— The Alzheimer’s Association filed a formal request
asking the Centers for Medicare & Medicaid Services (CMS) to provide full and unrestricted coverage for Food and Drug Administration (FDA)-approved Alzheimer’s treatments. In its letter, the Association asked CMS to remove the requirements for Coverage with Evidence Development (CED) in its national coverage determination (NCD) for FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.
Since CMS issued its coverage decision in April 2022, new clinical data have been published that clearly demonstrate a meaningful clinical benefit from a new treatment, lecanemab (Eisai/Biogen), currently under review by the FDA. There is growing consensus
in the scientific and medical communities about the clinical benefits of thorough removal of amyloid from the brain for people living with mild cognitive impairment (MCI) and early-stage Alzheimer’s disease. The Clarity AD trial results indicate treatments taken in the early stages of Alzheimer’s can deliver more time to participate in daily life and remain independent.
Alzheimer’s is a progressive and fatal disease. As new and better treatments for Alzheimer’s disease receive FDA approval, early access to these disease-modifying therapies is crucial. CMS is obligated to cover these FDA-approved treatments. Yet the agency departed from this precedent and went even further by applying its policy to all future treatments in this class without reviewing each treatment’s evidence first.
“Each day matters when it comes to slowing the progression of this disease,” said Joanne Pike, DrPH, Alzheimer’s Association president and incoming chief executive officer. “The current CMS policy to severely limit access to these treatments eliminates people’s options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That’s not acceptable.”
According to new estimates by the Alzheimer’s Association, each day CMS does not reverse this decision, more than 2,000 individuals aged 65 or older may transition from mild dementia due to Alzheimer’s to a more advanced stage of the disease where they may no longer be eligible for lecanemab, if approved, and the other antibodies targeting amyloid currently being tested.
“For people living with this fatal disease and their families, there is no time to waste,” said Dr. Pike. “CMS must reverse this policy.”
Read the Alzheimer’s Association request to CMS here.
Read the letter by the Scientific Community here.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.