The Centers for Medicare and Medicaid Services (CMS) must expand access to new treatments for Alzheimer’s patients, particularly Medicare beneficiaries living in rural and underserved areas of America, according to a bipartisan letter led by U.S. Rep. Darin LaHood (R-IL).
Specifically, the congressman, alongside U.S. Rep. Paul Tonko (D-NY) and 74 of their colleagues, asked CMS to reconsider the Coverage with Evidence Development (CED) requirements for Food and Drug Administration-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease.
“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,” wrote the lawmakers in a Feb. 6 letter sent to U.S. Secretary of Health and Human Services Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.
Rep. LaHood and his colleagues pointed out that two new mAbs that treat mild cognitive impairment due to Alzheimer’s disease and early-stage Alzheimer’s disease have recently received accelerated approval by the FDA, and they anticipate further decisions by the FDA on additional drugs in this class.
However, CMS last year evaluated a different mAbs treatment and issued a National Coverage Determination (NCD) for not just that product, but all future mAbs therapies, saying CMS would 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, according to their letter.
“This decision creates a barrier to care for older Americans, especially individuals living in rural and underserved areas,” wrote the members. “Alzheimer’s does not discriminate and patients across the country are losing access to this treatment based on CED requirements.”
Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment, Rep. LaHood and the lawmakers wrote, noting it’s “an enormous physical and financial burden” for Medicare beneficiaries to spend hours traveling to limited research institutions that host the trials.
“Unless CMS reconsiders the April 2022 NCD, access to disease-modifying therapy for Alzheimer’s disease will be extremely limited, nearly nonexistent, by the agency’s CED requirements,” they wrote.
Their effort has garnered support from the Alzheimer’s Association.