UsAgainstAlzheimer’s Statement on CMS Announcement of Registry for Access to FDA-Approved Alzheimer’s Treatments

UsAgainstAlzheimer’s Statement on CMS Announcement of Registry for Access to FDA-Approved Alzheimer’s Treatments 

Washington, D.C. (June 1, 2023)UsAgainstAlzheimer’s greeted the Centers for Medicare & Medicaid Services (CMS) potential approach to coverage of Food and Drug Administration (FDA)-approved Alzheimer’s treatments with continuing concern for patient access to disease-modifying drugs. Recent polling commissioned in part by the group showed that 84% of voters strongly agree Medicare should provide all beneficiaries access to Alzheimer’s medications the same way they provide access to FDA-approved medications for all other diseases.

George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, released the following statement in response to today’s news:

“Patients should have access to drugs found by the FDA to be safe and effective. While we are encouraged to see CMS making statements that seem consistent with recent testimony from the Administrator that Medicare will not limit access to drugs with full FDA approval, today’s announcement raises many questions. 

“The news release is silent on some of the same issues that the original coverage with evidence development (CED) raised: Will rural communities and areas without large, urban hospital systems be included? Will minority populations and those without financial means have equitable access? What will be the burden on doctors and patients participating in registries? 

“All Medicare patients should receive coverage to label without restricting access based on where you live or who your doctor is. In the end, CMS is still imposing a requirement on Alzheimer’s patients that hasn’t been required for anyone else who wants an FDA-approved drug. We urge CMS Administrator Brooks-LaSure to clarify how this potential registry will increase access to treatments and not create barriers to care for patients. The easiest way to clear up these questions is to eliminate CED requirements for drugs demonstrated in large clinical trials found by FDA to be safe and effective.”

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About UsAgainstAlzheimer’s
UsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and access to treatments – all regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.