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# CMS Questions FDA Aduhelm Approval: Analysis
- URL: https://www.fdaweb.com/cms-questions-fda-aduhelm-approval-analysis/
- Published: 2022-01-12T12:00:00.000Z
- Updated: 2026-09-14T17:28:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150917

Washington University in St. Louis law professor **Rachel Sachs** says the Center for Medicare and Medicaid Services (CMS) decision to propose restricting Medicare coverage of Biogen’s Aduhelm (aducanumab) “is likely … to fuel criticism of FDA’s accelerated approval program and its relationship to payers.” Writing in an online *Health Affairs* analysis, Sachs [says](https://www.healthaffairs.org/do/10.1377/forefront.20220112.876687?ref=fdaweb.com) state Medicaid programs may ask why they have to cover Aduhelm for Medicaid recipients when CMS believes it is not “reasonable and necessary” for Medicare beneficiaries without additional evidence.

The CMS draft national coverage determination says that monoclonal antibodies directed against amyloid to treat Alzheimer’s disease should be covered for Medicare beneficiaries only under its coverage with evidence development (CED) pathway. Sachs says this means that coverage would be limited to use in randomized controlled trials under conditions approved by CMS.

“We are proposing CED for antiamyloid because we strongly support clinical trials that will answer whether this treatment will benefit Medicare beneficiaries with Alzheimer’s disease,” CMS said. “None of the trials completed as of the publication of this national coverage decision has convincingly demonstrated that use of antiamyloid monoclonal antibodies results in a meaningful improvement in health outcomes for Alzheimer’s disease patients. More trials are needed and the results of these trials will assist in providing answers to CMS as well as clinicians, patients, and caregivers regarding the benefits and harms of this treatment.”

Sachs says this means that CMS was concerned with both the question of the drugs’ safety and their efficacy and that only rigorous clinical trials will suffice to answer both questions. “These statements may feel unusual coming from CMS rather than FDA, but the national coverage decision exists only because these questions were not answered as part of the FDA approval process,” Sachs writes.

She points out that although the timing of the draft coverage determination was driven by the Aduhelm approval, it was written more broadly to most likely also apply to other Alzheimer monoclonal antibody products now in the pipeline and hoping for FDA approval later this year.

“FDA may provide a more detailed explanation of its decisions later this year when asked to evaluate additional monoclonal antibodies in this category,” Sachs concludes. “Congress will also need to reauthorize the user fee amendments that provide FDA’s primary source of funding and accelerated approval reform may become part of that discussion.”