Statement on the CMS Aduhelm decision from the Right Care Alliance

PRESS STATEMENT

FOR IMMEDIATE RELEASE
CONTACT: Aaron Toleos, aaron@rightcarealliance.org, (978) 821-4620
January 12, 2022

The following can be attributed to Vikas Saini, M.D., chair of the Right Care Alliance:

Boston, MA — The Right Care Alliance applauds the decision by the Centers for Medicare and Medicaid Services (CMS) to restrict payments for the controversial new Alzheimer’s drug aducanumab, marketed by Biogen under the name Aduhelm. 

The CMS decision to pay for aducanumab only when patients are enrolled in research trials is well-justified and will prevent harms to older Americans who may have otherwise been prescribed this unproven drug. Aducanumab should be restricted to experimental settings until the medical community has better information about its benefits and harms. 

It’s a shame that it took a CMS decision to correct for the Food and Drug Administration’s (FDA) failure to do its job, which is protecting the American people from drugs that have no clear proof of benefit.

We call on the CMS to immediately reduce the 2022 increase in Medicare Part B premiums triggered by the prospective costs of aducanumab. CMS should reverse that premium increase and refund the 57 million seniors who have already paid the higher rate this month. 

We also maintain our call on the FDA to withdraw this drug from the market immediately and thoroughly re-examine their processes for granting Accelerated Approvals so that such ill-considered decisions can be avoided in the future.

This situation is a clear sign of regulatory capture at the FDA and yet another example of a health care system that too often puts corporate profiteering over the needs of the American people. The millions of Americans who care for loved ones with dementia deserve much better than an unproven, risky, and expensive drug like aducanumab. 

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The Right Care Alliance is a grassroots coalition of clinicians, patients, and community members organizing to make health care institutions accountable to communities and put patients, not profits, at the heart of health care.

In December 2021, they published a formal statement from a group of health professionals, most of them internationally recognized experts in Alzheimer’s disease research and treatment, calling on the U.S. Food and Drug Administration to withdraw approval of the drug aducanumab.