Washington D.C. – Yesterday, Congresswoman Nanette Diaz Barragán led 40 of her colleagues in the U.S. House of Representatives on a bipartisan letter to Health and Human Services (HHS) Secretary Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Brooks-LaSure urging them to re-propose or revise CMS’ National Coverage Determination (NCD) for monoclonal antibodies for the treatment of Alzheimer’s Disease (AD).

On January 11, 2022, CMS issued a draft NCD proposing that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease be covered for Medicare beneficiaries only under CMS’ Coverage with Evidence Development (CED) pathway. CMS proposes to cover them only if beneficiaries are enrolled in a randomized control trial conducted in an outpatient hospital setting. The proposal preemptively restricts access to an entire class of drugs before data on safety and efficacy are released to the FDA and duplicates already existing approval processes at the FDA. 

“This proposed Coverage with Evidence Development (CED) framework effectively denies access to an entire – and currently the only—known class of drugs that is reasonably likely to affect the course of the disease,” the members wrote. “We are very concerned about the impact that this proposed rule would have on Alzheimer’s patients – including patients of color and patients with a higher risk of Alzheimer’s such as people with Down Syndrome– and their families who have waited far too long for a new Alzheimer’s therapeutic.”

The members continued, “As thousands of patients per day progress to later stages of the disease and become ineligible for these therapeutics, Americans cannot wait while CMS further delays access. The requirement that the drugs be administered in a hospital outpatient setting – thereby ruling out many alternative sites of care frequented by disadvantaged communities – may inadvertently exclude people of color, people who are low income, people who have a disability, and people who live in rural area.”

“I know the impact of Alzheimer's firsthand -- I’ve watched my mom struggle with Alzheimer’s over the last several years. Her disease is so advanced that she is no longer able to benefit from scientific, breakthrough therapies that could improve her condition. However, there are still other people out there who can benefit. CMS’ draft coverage proposal will be detrimental to the millions of families and individuals suffering from this heartbreaking disease.” said Congresswoman Barragán. “No one should lose the opportunity to benefit from life-altering clinical trials because of denied coverage. That is why we must work to ensure these breakthrough therapies are accessible. CMS should not include this entire class of disease-modifying drug in their final coverage decision. This is going to limit access to these therapies for millions of people who

“According to the CDC, communities of color experience a higher rate of Alzheimer’s Disease. African Americans ages 65 and older have the highest prevalence of Alzheimer’s disease and related dementias, followed by Hispanics, and non-Hispanic whites, American Indian and Alaska Natives, and Asian and Pacific Islanders. CMS' decision is concerning due to the severely limited access underserved populations will have to clinical trials for an entire and only known class of drugs to treat Alzheimer's because they do not usually live near hospitals in major cities, where the clinical trial sites are located,” said Congresswoman Barbara Lee. “It is critical that CMS revise its National Coverage Determination (NCD) for monoclonal antibodies for the treatment of Alzheimer’s Disease (AD) to ensure equitable access to life-saving Alzheimer’s treatment.”

“I am calling on CMS to reverse their proposed national coverage decision to restrict Medicare beneficiaries’ access to Aduhelm, a recently approved Alzheimer’s treatment, and all future similar treatments being developed to treat Alzheimer’s Disease. This proposal will not only arbitrarily limit access to these breakthrough therapies for people living with Alzheimer’s, including individuals with Down Syndrome, but it will also discourage future investments in research to find a cure to Alzheimer’s Disease. CMS must reverse their decision” said Rep. Guthrie.

“Alzheimer’s disease is one of the leading causes of death in the U.S., affecting millions of Americans and their families. This is an awful disease that needs to be further researched,” said Rep. Miller-Meeks. “Revising the National Coverage Determination for monoclonal antibodies for Alzheimer’s disease treatments would allow better treatment for more Americans. We need to continue to work in a bipartisan manner to support Alzheimer’s treatment and research and I am proud to help lead this effort.”

“Congresswoman Barragan has been a true leader in the fight to protect Alzheimer’s patients on Medicare. She knows what’s at stake here. If Medicare doesn’t cover FDA-approved Alzheimer’s drugs, millions of Americans will be without treatment options for as long as ten years. With 1,000 people slipping from mild to moderate Alzheimer’s every day, delay can be fatal,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “On behalf of the nation’s six million people living with Alzheimer’s, I thank Congresswoman Barragan and all the members who signed this letter for their work to ensure Medicare recipients have access to FDA-approved treatments. I only hope CMS will do the right thing.”

“Medicare is likely to deny coverage for the first FDA-approved Alzheimer’s disease treatment in more than 20 years for most beneficiaries who could benefit. The delay CMS’ draft policy would impose is personal and existential for the patients and families facing the disease. It would be especially painful, tragic, and unacceptable for CMS to make such a decision based on a fundamental misunderstanding of the science of disease-modification and through an unfortunate discordance with the FDA,” said Sue Peschin, MHS, President and CEO of the Alliance for Aging Research, which convenes the Alzheimer’s Disease Policy Task Force. “We thank Congresswoman Barragán for her leadership on this powerful, bipartisan letter. HHS Secretary Becerra and CMS Administrator Brooks-LaSure should adopt the letter’s recommendations to ensure that people living with Alzheimer’s disease, informed by their doctors, have the choice of whether to use FDA-approved drugs. Our older family members and neighbors paid into the Medicare program to provide care for those before them. We should honor their contributions to the program and ensure they have the coverage they deserve.”

“Thank you Representatives Diaz Barragán, Lee, Guthrie, and Miller-Meeks and congressional champions on both sides of the aisle for advocating in support of people living with Alzheimer’s and their families, and your efforts to ensure people living with Alzheimer's have access to FDA-approved treatments. The proposed CMS decision would not only sharply limit access to an FDA-approved treatment, but it would also limit access to an entire class of drugs. On behalf of the Alzheimer's community, we are grateful for your leadership and for supporting the millions of people living with this devastating disease,” said Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director.

“Alzheimer’s Disease is a growing public health concern. We urge CMS to revise its proposed decision and issue a final decision that would provide coverage for treatments and addressing how its final decision will limit barriers to equitable access for communities historically excluded from clinical research,” said Yanira Cruz, MPH, DrPH, President and CEO of the National Hispanic Council on Aging. “We cannot have yet another generation of Alzheimer’s patients left without access to therapeutics.”

A copy of the letter is below 

The Honorable Xavier Becerra

Secretary Health and Human Services

200 Independence Avenue, SE

Washington, DC 20201

The Honorable Chiquita Brooks-LaSure

Administrator

Centers for Medicare & Medicaid Services

7500 Security Blvd

Baltimore, MD 21244 

Dear Secretary Becerra and Administrator Brooks-LaSure,

We write to express our strong concern regarding the Centers for Medicare and Medicaid Services’s (CMS) proposed non-coverage determination for monoclonal antibodies for the treatment of Alzheimer’s Disease (AD) issued on January 11, 2022. We urge you to re-propose or revise the proposed decision and issue a final decision that would provide coverage for treatments as indicated by the Food and Drug Administration (FDA) label, while continuing to carefully assess the effects of drugs in real-world populations. Further, we request that CMS ensure that its final coverage decision will not reinforce barriers to equitable access for communities historically excluded from clinical research.

We understand CMS’s expressed desire to gather evidence on new Alzheimer’s treatments, but this proposed Coverage with Evidence Development (CED) framework effectively denies access to an entire – and currently the only—known class of drugs that is reasonably likely to affect the course of the disease. We are very concerned about the impact that this proposed rule would have on Alzheimer’s patients – including patients of color and patients with a higher risk of Alzheimer’s such as people with Down Syndrome– and their families who have waited far too long for a new Alzheimer’s therapeutic. As thousands of patients per day progress to later stages of the disease and become ineligible for these therapeutics, Americans cannot wait while CMS further delays access.

Latinos are 1.5 times as likely and African Americans are two times as likely to develop Alzheimer’s when compared to non-Hispanic White Americans.i More than 60 percent of people living with Alzheimer's are women and more than 60 percent of dementia caregivers are women. When seeking Alzheimer’s care, 34% of Asian Americans experienced some form of discrimination compared to 9% of white Americans.ii Additionally, it is estimated that greater than 90 percent of people with Down Syndrome over the age of 60 develop AD. Despite this higher risk, these communities face major gaps in access to Alzheimer’s diagnostics, treatments, and research. As drafted, the proposed NCD will severely limit access to current and future FDA approved treatments for these communities.

CMS's decision to restrict access to participants enrolled in qualifying randomized controlled trials (RCT) in a hospital outpatient setting will limit coverage only to individuals with access to traditional clinical trial sites.iii On average, these trial sites have posed significant challenges for people of color and lower income families in Alzheimer’s research studies from both a design and recruitment standpoint. The trials themselves and the requirement that the drugs be administered in a hospital outpatient setting – thereby ruling out many alternative sites of care frequented by disadvantaged communities – may inadvertently exclude people of color, people who are low income, people who have a disability, and people who live in rural areas.

A progressive disease such as Alzheimer’s by its nature requires the earliest possible intervention, which is the direction science is moving. The class of drugs covered by the decision is aimed at delaying the progression of disease for persons in the early stages of Alzheimer’s disease. By attacking the disease early, though, evidence of direct clinical benefit is very hard to discern. Waiting for the slope of the disease to grow steeper when clinical benefit is easier to detect is almost certainly too late to help the patient. This is the essence of the FDA’s accelerated approval pathway and why scientists are dependent on surrogate endpoints (such as beta amyloid) for evidence of efficacy.

We believe that as more evidence is gathered, patients and their families should be given the choice as whether, when faced with a disease that is a death sentence, to access approved AD treatments in consultation with their doctors. This is commonly accepted practice for cancer patients, and we believe Alzheimer’s patients should be given similar deference.

Like you, we, and millions of other American families, have personally experienced the tragic consequences of AD. While there may be legitimate, appropriate needs to gather data about treatments in the Medicare population, drugs that have been found to be safe and effective, or reasonably likely to be so, by the FDA should be available to the Medicare population in consultation with their doctors. We are concerned that these additional CMS requirements to confirm the safety and effectiveness of the AD treatments for Medicare patients duplicates the existing FDA approval process which has already been completed by one AD treatment. Furthermore, we are deeply concerned with the unprecedented requirement of randomized controlled trials for an entire class of drugs, including an FDA-approved product and multiple drugs at various stages in the development pipeline, that will preemptively restrict access to an entire class of drugs and discourage ongoing and future research and development in AD treatments or cures.

In summary, we believe there is a way to gather additional evidence where needed while not denying access to patients in desperate circumstances in the meantime. These mechanisms include the data that will be collected through the Phase IV Aduhelm trials, the Phase III results for multiple other monoclonal antibodies for treating Alzheimer’s disease, as well as the current FDA adverse reaction reporting mechanisms which are well respected and effective.

Thank you for all you and the department are doing to fight Alzheimer’s disease. We urge you to ensure that CMS makes the significant changes needed as outlined above. We cannot have another generation of Alzheimer’s patients left without access to therapeutics.

Sincerely,

Nanette Diaz Barragán

Member of Congres 

Barbara Lee

Member of Congress

Brett Guthrie

Member of Congress

Mariannette J. Miller-Meeks, M.D.

Member of Congress 

Henry Cuellar

Member of Congress

Brian Fitzpatrick

Member of Congress

Ritchie Torres

Member of Congress

Maria Elvira Salazar

Member of Congress

James P. McGovern

Member of Congress

Elise Stefanik

Member of Congress

J. Luis Correa

Member of Congress

Earl L. "Buddy" Carter

Member of Congress 

Karen R. Bass

Member of Congress

French Hill

Member of Congress

Bonnie Watson Coleman

Member of Congress

Fred Upton

Member of Congress

Paul D. Tonko

Member of Congress

Brian Mast

Member of Congress

Cheri Bustos

Member of Congress

John Joyce, M.D.

Member of Congress

Alma S. Adams, Ph.D.

Member of Congress

Guy Reschenthaler

Member of Congress

Madeleine Dean

Member of Congress

Tom Cole

Member of Congress 

Deborah K. Ross

Member of Congress

Richard Hudson

Member of Congress

Tom O'Halleran

Member of Congress

John H. Rutherford

Member of Congress

Grace F. Napolitano

Member of Congress

Jeff Van Drew

Member of Congress

Jimmy Panetta

Member of Congress 

Carol D. Miller

Member of Congress

Vicente Gonzalez

Member of Congress

Tim Burchett

Member of Congress

Kaialiʻi Kahele

Member of Congress 

Adrian Smith

Member of Congress 

Troy A. Carter, Sr.

Member of Congress

David G. Valadao

Member of Congress

Robert E. Latta

Member of Congress

Kevin Hern

Member of Congress

Michael C. Burgess, M.D.

Member of Congress

Sheila Cherfilus-McCormick

Member of Congress

Yvette D. Clarke

Member of Congress

 Neal Dunn

Member of Congress

About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.