Every day, more than 2,000 older adults living with mild dementia may transition to a more advanced stage of the disease and no longer be eligible for lecanemab and other antibodies targeting amyloid under a coverage decision made by the federal government in April, the Alzheimer’s Association said Monday. The estimate came as the association formally requested that the Centers for Medicare & Medicaid Services provide full coverage for Food and Drug Administration-approved Alzheimer’s treatments.
In a letter to CMS Administrator Chiquita Brooks-LaSure, the association asked that the agency remove requirements for “coverage with evidence development” — or coverage of the drug only during a clinical study — in CMS’ national coverage determination for FDA-approved monoclonal antibodies targeting amyloid in part of the treatment of Alzheimer’s disease.
Dropping the requirements, the association said, would provide unrestricted coverage for the class of treatments.
The Alzheimer’s Association said that growing consensus exists in the scientific and medical communities about the clinical benefits of amyloid removal from the brains of those living with mild cognitive impairment and early-stage Alzheimer’s disease. It also pointed to new clinical data demonstrating a benefit from lecanemab, which is now under review by the FDA.
“Each day matters when it comes to slowing the progression of this disease,” Joanne Pike, DrPH, Alzheimer’s Association president and incoming CEO, said in a statement. “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.”
More than 200 Alzheimer’s researchers and experts also have called for “equitable access” to lecanemab and other disease-modifying treatments and have called for patients to be given the opportunity to make informed choices regarding their treatments.
“No barrier can be allowed to stand between our patients and a treatment that has a reasonable risk-benefit ratio and significantly reduces the causative pathology,” the letter reads. “We herald the foundational advance represented by the advent of lecanemab therapy. Now, we must build on the success of science to translate these gains into even better outcomes for patients and families.”