Aduhelm was the first new approved Alzheimer’s treatment since 2003. Medicare’s announcement stems from a controversy that erupted in June 2021 when the FDA gave conditional approval to another amyloid-clearing drug, Aduhelm, which had also been developed by Biogen and Eisai.
“It’s unfair for individuals who could benefit from those treatments to not have access,” she said in an interview at the Waltham offices of the association’s Massachusetts and New Hampshire chapter. The association estimates that more than 6.7 million Americans, mostly older, are living with Alzheimer’s, a progressive disease that destroys memory and other mental functions. Joanne Pike, visited Massachusetts and called on CMS to reimburse all patients eligible for the new class of drugs immediately, even if they only have conditional approval. Last week, the new head of the national Alzheimer’s Association, Dr. “Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients. “We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’ promise of broad coverage to all Medicare beneficiaries,” the Indianapolis-based firm said in a statement. It said Medicare should cover FDA-approved Alzheimer’s medicines without requiring patient enrollment in registries. “Historically, registries have not equally or comprehensively served all patients, especially those in underserved communities and geographical regions that have barriers to medical care,” the company said in a statement.Įli Lilly, which hopes to win approval of a rival experimental Alzheimer’s drug, donanemab, was more critical. After Medicare’s announcement Thursday morning, a Biogen spokesperson said, “While we are encouraged to see CMS’ intention to broaden access to these therapies, more details are needed to understand the implications of the proposed registries.”Įisai also said it wanted more information about the database.
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