Alliance Criticizes CMS Decision to Restrict Access to Alzheimer’s Therapies

WASHINGTON, D.C. (Feb. 23, 2023) — The Centers for Medicare and Medicaid Services (CMS) announced yesterday that it will not reconsider its decision to severely restrict Medicare coverage for monoclonal antibodies that treat Alzheimer’s disease. In response, Sue Peschin, President and CEO of the Alliance for Aging Research, issued the following statement:

For years, the Medicare program has gotten away with paying only a fraction of the lifetime costs for Alzheimer’s care because there have not been effective treatments available. By continuing to ration coverage of FDA-approved monoclonal antibodies for Alzheimer’s disease, Medicare has made it clear that it does not consider people with early-stage dementia worth treating.

CMS’s decision ignores continuously mounting scientific evidence showing that these monoclonal antibodies are effective at delaying the debilitating and deadly progression of Alzheimer’s. It abuses an extralegal paradigm called coverage with evidence development (CED) to ration access to these therapies. Under CED, Medicare covers FDA-approved treatments on a very limited basis, and under the condition that beneficiaries must enroll in a clinical trial or patient registry.

Make no mistake; despite CMS’s posturing about expanded access following a traditional FDA approval, only a small number of patients with early-stage Alzheimer’s disease would have access to treatment under a mandatory registry coverage requirement. That may save Medicare money. But it does so by depriving vulnerable people, especially those who live in rural areas and people of color, of care.

Americans pay into Medicare their whole lives. They have a reasonable expectation that the program will take care of them in old age. With this decision, CMS has declared that people with Alzheimer’s should have no such expectations. CMS’s announcement comes despite the American Academy of Neurology (AAN) recently asking CMS to reconsider the National Coverage Determination (NCD) for Alzheimer’s disease and that CMS begin a “focused expedited review of the NCD as it pertains to lecanemab.”

Medicare’s refusal to provide comprehensive coverage of Alzheimer’s medicines will be felt far beyond the Alzheimer’s community. Federal officials will be able to use it as a precedent to further undermine the FDA’s authority and restrict access to future therapies for other serious conditions, such as cancer, ALS, and rare diseases.

CMS says it “regrets” that its decision could not be more favorable. Exactly who oversees this decision, if not CMS? The agency’s statement reveals a stunning lack of accountability by CMS Administrator Brooks-LaSure, HHS Secretary Becerra, and the Biden Administration. Shame on all of them.

We call upon President Biden to act. CMS’s actions are out of step with the President’s stated commitment to individuals with Alzheimer’s disease. It is time for the White House to intervene and urge CMS to reconsider.

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To schedule an interview with Sue Peschin, president and CEO of the Alliance for Aging Research, please contact Katie Riley, Vice President of Communications, Alliance for Aging Research, at [email protected].