Senator Collins’ Statement on FDA Decision to Grant Full Approval of Alzheimer’s Drug
Washington, D.C.— Today, U.S. Senator Susan Collins (R-ME), the chairman and founder of the Senate Alzheimer’s Task Force, expressed support for the U.S. Food and Drug Administration’s (FDA) decision to grant full approval of the Alzheimer’s drug, Leqembi:
"FDA's approval of Leqembi is a new milestone in the treatment of Alzheimer's disease and is welcome news for millions of Americans and their families," said Senator Collins. "As the FDA concluded today, Leqembi has proven clinical benefits and, while not a cure, will provide many patients with mild cognitive impairment or early stage Alzheimer's disease more time to participate in daily life and live independently. Now that Leqembi has received traditional approval, there should be no barriers to accessing this disease-modifying therapy if the clinician, patient, and their family decide it is right for them."
On January 6, 2023, FDA granted accelerated approval of Leqembi (lecanemab) for the treatment of patients in mild cognitive impairment or mild dementia stage of Alzheimer’s disease and with confirmation of amyloid beta. Under the national coverage determination (NCD) currently in place, however, CMS will only cover monoclonal antibodies treating Alzheimer’s and other dementia approved through the accelerated approval pathway for individuals enrolled in randomized clinical trials and treatments approved through the traditional approval pathway when patients are enrolled in prospective comparative studies.
Senator Collins has led the charge against this unprecedented action taken by CMS. In March, she authored a bipartisan letter that was signed by 20 senators urging CMS to stop putting promising new treatments out of reach for most patients. As Vice-Chair of the Senate Appropriations Committee, Senator Collins also urged Secretary Xavier Becerra to direct CMS to reconsider its unfair coverage decision. Since then, Senator Collins has spoken to the CMS Administrator Chiquita Brooks-LaSure directly about access challenges, particularly for individuals in rural areas, and CMS’s current Coverage with Evidence Development (CED) requirements. After speaking directly with Senator Collins about CMS’s registry plans, CMS Administrator Chiquita Brooks LaSure confirmed that there will not be a provider fee to participate in required registries. Now that the FDA has granted traditional full approval, there is no justification for CMS not to cover the medication.
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