A bipartisan group of attorneys general from 23 states have joined a growing chorus calling on Medicare to reverse a previous decision and provide unrestricted coverage of Food and Drug Administration-approved monoclonal antibody treatments for Alzheimer’s disease.
In a letter to US Department of Health and Human Services Secretary Xavier Becerra and Centers for Medicare & Medicaid Services Administrator Chicquita Brooks-LaSure, the state attorneys asked CMS to reconsider the requirements for coverage.
“Specifically, we ask that CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer’s treatments, consistent with its decades-long practice of covering FDA approved prescription drugs for Medicare beneficiaries,” the letter read. “This coverage will ensure that all Americans benefit from treatments that the FDA has concluded are ‘important advancements in the ongoing fight to effectively treat Alzheimer’s disease.’ ”
In April 2022, Medicare announced that it would limit its coverage of FDA-approved monoclonal antibody treatments used to treat amyloid plaques in the brains of those living with Alzheimer’s. The federal government only covers drugs approved under the FDA standard review process, not under the accelerated review program. CMS’ decision about Alzheimer’s medications further limits coverage to treatments administered through clinical trials or other studies.
“This decision creates a barrier to care for older Americans, especially individuals living in rural and underserved areas that are unlikely to be served by institutions administering clinical trials,” the letter read, adding that ensuring patient access to potential life-changing treatments is important for everyone.
The AG letter follows a similar request by the Alzheimer’s Association and bipartisan letters from the House and Senate emphasizing the importance of access to FDA-approved treatments. Lawmakers in a Senate Finance Committee hearing in March also called for the federal government to speed up access to Alzheimer’s treatments.
During her testimony before the House Committee on Energy and Commerce’s Health Subcommittee last month, Brooks-LaSure was peppered with questions and comments about CMS’ coverage decision, including its rejection of a request to expand its coverage of monoclonal antibody treatments and continue to limit access to a class of Alzheimer’s treatments targeting amyloid, including aducanumab (Aduhelm) and lecanemab (Leqembi).
“Directing CMS to reconsider its requirements for CED for FDA-approved mAbs may be the most impactful decision of your careers — and certainly the lives of millions of Americans,” the AG letter concluded.