Global Alzheimer’s Platform Foundation® (GAP) Condemns CMS Preliminary Coverage Decision on First Disease Modifying Drug for Alzheimer’s as Repudiation of President’s Promise to Advance Treatments for Alzheimer’s for all Americans

GAP calls for a traditional National Coverage Determination for ADUHELM consistent with past CMS decisions which will ensure access and equity for all patients stricken with Alzheimer’s.

Washington, D.C. (January 11, 2022) – John Dwyer, President of the Global Alzheimer’s Platform Foundation® (GAP), a person-centric non-profit organization committed to accelerating the discovery of therapies for the treatment of Alzheimer’s, issued the following statement on the announcement today by the Centers for Medicare and Medicaid Services (CMS) of a preliminary proposal to cover U.S. Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.

“CMS’s preliminary decision to delay and restrict coverage for the first disease modifying drug for Alzheimer’s is unprecedented, reckless, and stands in direct opposition to the President’s personal commitment to better address the Alzheimer’s public health crisis in the U.S. and improve access to life prolonging Alzheimer’s therapies for all Americans.

The FDA  – the established authoritative body responsible for evaluating the safety and efficacy of newly developed drugs – granted accelerated approval to ADUHELM because it concluded the drug was “reasonably likely” to provide clinical benefit. This process was approved by Congress, and the FDA has employed it hundreds of times to accelerate access to cancer, HIV and other therapies. CMS has never refused to cover a drug approved through this mechanism when coverage was for use consistent with the FDA label.

This preliminary ruling throws patient access out the window for most Americans. 13 percent of Black and Hispanic Americans over the age of 65 are thought to have Alzheimer’s or related dementias. These communities are two-to-three times and one-and-one-half times more likely to develop the disease, respectively. Without access to the only approved disease modifying treatment for Alzheimer’s, disease prevalence amongst Black and Hispanic Americans will increase unabated, reaching 6 million individuals by 2060. Additionally, at a time when Americans are being hit hard by the COVID-19 pandemic and the resulting economic impacts, this decision fails to bring a sense of economic and health security back to a country in need. The average American can’t afford to pay high out-of-pocket costs for a medicine like ADUHELM when their wallets are already being drained by everyday costs.

It’s imperative that CMS recognize the error in its ways and alter this ruling come April when a permanent decision on the matter is expected. The Biden Administration has failed to live up to its word and is jeopardizing the health of the American people to presumably lower costs. We must hold them accountable.”

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