Access to federally approved monoclonal antibody and other disease-modifying therapies for Alzheimer’s disease will be “extremely limited” unless the Centers for Medicare & Medicaid Services reconsiders coverage requirements, according to a bipartisan group of senators.
US Sen. Susan Collins (R-ME), a founder and co-chair of the Congressional Task Force on Alzheimer’s Disease, and Sen. Shelley Moore Capito (R-WV) led a group of 20 colleagues in sending a letter to US Department of Health & Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, urging CMS to expand access to Alzheimer’s treatments.
The Feb. 17 letter calls on CMS to reconsider the coverage with evidence requirements for Food and Drug Administration-approved monoclonal antibodies directed at amyloid for the treatment of Alzheimer’s disease.
Approximately 34% of assisted living residents are living with diagnosed dementia, according to the Centers for Disease Control and Prevention.
The FDA granted accelerated approval of lecanemab (brand name Leqembi) in January as a treatment for people with mild cognitive impairment or mild dementia, with confirmation of amyloid beta. Under the national coverage determination in place, CMS only covers monoclonal antibody treatment approved through the accelerated approval pathway for people enrolled in randomized clinical trials, or treatments approved through the traditional pathway when people are enrolled in prospective comparative studies.
“Unless CMS reconsiders the April 2022 [national coverage determination], access to lecanemab and other disease-modifying therapies for Alzheimer’s disease will be extremely limited,” the letter reads. “Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient.”
Coverage decision delays, which can last several months, can create “significant access delays,” resulting in irreversible disease progression and added burdens for caregivers, the senators noted. Based on projections from the Alzheimer’s Association, more than 2,000 older adults transition daily from mild to moderate dementia due to Alzheimer’s disease, they added.
“This overdue CMS action will ensure Medicare beneficiaries living with mild cognitive impairment due to Alzheimer’s disease and early stage Alzheimer’s disease have immediate access to FDA-approved treatments if the patient and clinician decide it is right for them,” the letter concludes.
Robert Egge, Alzheimer’s Association chief public policy officer, said the association supports the effort. The association previously asked that CMS provide full coverage for FDA-approved Alzheimer’s treatments.
“CMS is blocking people living with early stage Alzheimer’s from accessing FDA-approved Alzheimer’s treatments,” Egge, also the executive director of the association’s Alzheimer’s Impact Movement, said in a statement. “Each day without access to and coverage of treatment, these individuals are losing memories, skills and, most importantly, time with their loved ones.”
By 2050, almost 13 million Americans are projected to have received a diagnosis of Alzheimer’s disease, according to the Alzheimer’s Association. Last year, the disease cost the nation $321 billion, with Medicare and Medicaid covering 67% of the cost. Those costs are projected to reach $1 trillion by 2050.
