Letter raises concerns with CMS regarding its draft National Coverage Determination (NCD) decision memo
FOR IMMEDIATE RELEASE
April 1, 2022
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 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.
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Nanette Diaz Barragán is proud to represent California’s 44th Congressional District, which includes the communities of Carson, Compton, Florence-Firestone, Lynwood, North Long Beach, Rancho Dominguez, San Pedro, South Gate, Walnut Park, Watts, Willowbrook and Wilmington. She serves as chairwoman of the House Homeland Security Committee’s Subcommittee on Border Security.