WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Ed Markey (D-MA), Co-Chairs of the Congressional Task Force on Alzheimer’s Disease, were joined by Sens. Chris Van Hollen (D-MD) and Debbie Stabenow (D-MI) today in raising concerns with the Centers for Medicare and Medicaid Services (CMS) regarding its draft National Coverage Determination (NCD) decision memo for the drug Aduhelm and other similar Alzheimer’s treatments.

In the January 11, 2022 proposed decision memo, CMS groups together an entire class of Alzheimer’s drugs, despite the fact that many are in different stages of the testing and approval pipeline. It also proposes to cover them only if beneficiaries are enrolled in a randomized control trial conducted in an outpatient hospital setting.

“Monoclonal antibody treatments that target amyloid plaques in the brain are the therapies farthest along in their potential for treating certain individuals with Alzheimer’s disease,” the senators wrote. “We are concerned that by including the entire class of drugs in this coverage decision—before final data on safety and efficacy are even released on other therapies in the pipeline—CMS may limit future access to treatments.”

The senators continued, “Although all in the same class, no two drugs work exactly the same for all individuals. Further, the evidence gathered from Aduhelm’s FDA confirmatory trial as well as additional evidence gathered by CMS may inform coverage decisions of potential future drugs. Each new medicine, in our view, should be reviewed on its own merits and not as a class.”

Noting that Black and Latino populations have higher incidences of Alzheimer’s, the Senators also called on CMS to ensure that any clinical trial requirements do not inadvertently limit access to treatments for people of color.

“On behalf of people living with Alzheimer’s and their caregivers, thank you Senators Warner, Markey and other Senate leaders for sharing your concerns with CMS about the national coverage determination proposed decision and encouraging them to expand coverage of FDA-approved treatments for people living with Alzheimer’s. As it stands, the current draft would sharply limit access to an entire class of drugs. For the individuals living with this fatal disease, delaying and limiting access to treatment could mean further progression of their cognitive decline. We appreciate your continued leadership on issues important to the Alzheimer’s community,” said Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director.

“It is critically important to the Alzheimer’s community that CMS understand what many members of Congress already do: it’s wrong for Medicare to deny access to FDA-approved Alzheimer’s treatments. This would not happen with cancer, and it must not happen with Alzheimer’s,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “I applaud the senators for working on behalf of patients to increase access to this class of drugs, particularly among people of color. Every day 1,000 Americans slip from mild to moderate Alzheimer’s and out of the disease stage targeted by this class of drugs. We do not have time to wait. And we will not stop our campaign until this injustice is corrected.”

As Co-Chair of the Congressional Task Force on Alzheimer’s Disease Sen. Warner has been a longstanding advocate in Congress for improving access and quality of medical care for some of our country’s most vulnerable patients. Last week, Sens. Warner and Markey celebrated the addition of $3.5 billion for Alzheimer’s and related dementia research funding at the National Institutes of Health (NIH) in the Fiscal Year 2022 omnibus spending bill. In 2018, Sen. Warner led colleagues in calling on the Trump administration to continue investing in Alzheimer’s research.  Previously, he introduced bipartisan legislation designed to give people with advanced illness, such as Alzheimer’s disease, new tools to plan for their care and empower them to have those choices honored.

A copy of the letter is available here and below. 

Dear Administrator Brooks-LaSure:

We’re writing to share concerns about the recently proposed National Coverage Determination (NCD) decision memo for Aduhelm and similar drugs, released by the Centers for Medicare & Medicaid Services (CMS) on January 11, 2022. Although more data is needed on Aduhelm’s impact on Alzheimer’s disease, we urge you not to include in the NCD the whole class of similar drugs that have not yet been considered by the Food and Drug Administration. Further, we ask that CMS work to ensure that in any studies required by CMS, robust and representative participation by communities of color are prioritized.

As CMS notes in its decision memo, more than 6 million people in America have Alzheimer’s disease and this is expected to rise to 14 million by 2060. Monoclonal antibody treatments that target amyloid plaques in the brain are the therapies farthest along in their potential for treating certain individuals with Alzheimer’s disease. We are concerned that by including the entire class of drugs in this coverage decision—before final data on safety and efficacy are even released on other therapies in the pipeline— CMS may limit future access to treatments.

As you know, there is a large unmet need for treatments for those with Alzheimer’s, a devastating and fatal disease. In Aduhelm’s class of drugs, three drugs are working their way through the FDA approval process. Although all in the same class, no two drugs work exactly the same for all individuals. Further, the evidence gathered from Aduhelm’s FDA confirmatory trial as well as additional evidence gathered by CMS may inform coverage decisions of potential future drugs. Each new medicine, in our view, should be reviewed on its own merits and not as a class.

Additionally, CMS should ensure that its final NCD does not make it more difficult for Medicare beneficiaries of color to both obtain these treatments if trials are required by CMS and also for us to obtain needed data on Alzheimer’s treatments in such trials, as Black and Latino populations have higher incidences of Alzheimer’s than non-Hispanic whites. The draft NCD proposes to limit coverage only to drugs administered in hospital outpatient settings. This will make it significantly more difficult, if trials are required, to enroll beneficiaries of color, as aggressive outreach and the use of disparate sites is often needed to meet diversity targets. The draft NCD’s requirement for randomized controlled trials could also limit inclusion of people of color, as these populations are often underrepresented in such trials.

Alzheimer’s patients and their families have been waiting 20 years since the last therapy was approved, and this class of therapies holds the promise that those living with the disease may soon have multiple disease-modifying therapies from which to choose. Time is not on the side of those with Alzheimer’s, and we urge you to issue a final NCD that puts patients and their loved ones first by examining each potential new treatment on its own.

Thank you for your commitment to ending Alzheimer’s disease, and we look forward to continuing our work with you in this crucial area.

Sincerely,

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