Advocates of those living with Alzheimer’s disease are expressing disappointment that the Centers for Medicare & Medicaid Services on Wednesday rejected a request to expand its coverage of monoclonal antibody treatments.
The announcement by the agency is a reaffirmation of the federal government’s Alzheimer’s drug coverage policy.
CMS declined to reconsider the national coverage determination it made in April 2022 for Food and Drug Administration-approved monoclonal antibodies, used to treat amyloid plaques in the brains of those with Alzhiemer’s. The federal government only covers drugs approved under the FDA’s standard review process, not under the accelerated review program.
“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” the agency announced, adding that it believed that not enough evidence exists to meet the criteria for reconsideration.
In response, the Alzheimer’s Association said it was “appalled” at the “unjust decision” to deny beneficiaries access to FDA-approved treatments for a “fatal disease.” The association stated that despite “significant new evidence” published since CMS’ release of its original decision, the agency denied its request. The association noted that the agency covers all FDA-approved drugs except for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.
“CMS’ role is to provide healthcare coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate,” Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a statement. “Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary.”
The Alzheimer’s Association had bipartisan congressional support of its request for reconsideration, as stated in letters from the House and Senate sent earlier this month to Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure emphasizing their belief in the importance of access to FDA-approved treatments.
Each day, more than 2,000 older adults transition from mild dementia to a more advanced stage of the disease, making them ineligible for the new FDA-approved treatments, according to the association.
“Each day matters to someone living with early stage Alzheimer’s disease when it comes to slowing the progression of this disease,” Pike said. “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.”
In its response to the Alzheimer’s Association, CMS outlined key questions that it wants to be addressed for reconsideration, including a determination that a medication is “reasonable and necessary.” The agency indicated that it would “expeditiously review” any new evidence that could lead to a reconsideration and change in the national coverage determination.
George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, however, said that “CMS’ arguments are simply empty and erroneous rhetoric.”
“The agency says it is committed to getting people ‘timely access’ to Alzheimer’s treatments, but it just reiterated a decision to deny Medicare coverage of a promising new drug that demonstrably slows the progression of Alzheimer’s,” he said. Vradenburg noted that the American Academy of Neurology said in a Feb. 2 letter to CMS that the questions the agency has “have already been answered in a massive, successful clinical trial and a peer-reviewed publication reviewing the results of that trial.”
Vradenburg called the CMS decision “unconscionable and unjustifiable” and predicted that it would have “dire consequences for people living with Alzheimer’s.”
Approximately 34% of assisted living residents are living with diagnosed dementia, according to the Centers for Disease Control and Prevention.