83% of Neurologists: One drug shouldn’t determine the fate of an entire class

 20,000 letters sent to White House and Congress urging reversal of draft Medicare coverage plan that would effectively block access to new class of Alzheimer’s drugs

Washington, D.C. (February 2, 2022) – An extreme and sweeping proposed plan that would effectively deny Medicare coverage for an entire class of Alzheimer’s drugsis drawing strong opposition from doctors, scientists and patient advocates.

The draft proposal by the Centers for Medicare and Medicaid Services (CMS), announced January 11, would deny Medicare coverage for the entire first class of treatments that slow the progression of the disease, except for the small number of patients who are able to participate in restrictive clinical trials. The proposal is open for public comment through February 10 with a final coverage decision by CMS for Medicare beneficiaries expected in April.

The proposal follows approval by the Food and Drug Administration (FDA) of the first drug in the class, Aduhelm, but affects the entire class – including those treatments still being developed. Patient advocates, scientists, doctors and others highlight the severe effects on patients from this CMS coverage proposal, which could delay Alzheimer’s treatment for a decade.

Poll: Practicing Neurologists Say One Drug Should Not Set Coverage of Entire Class

A new survey of more than 200 practicing neurologists, the majority of whom care for at least 11 Alzheimer’s patients a week, shows that 83 percent believe that results of one medication should not be used to determine the safety and efficacy of an entire class of drugs. The confidential online survey of 209 licensed neurologists in the U.S. with at least one year of clinical experience was conducted January 26-31, 2022, by UsAgainstAlzheimer’s and the Global Alzheimer’s Platform.

“When you talk to doctors who are actually treating patients and scientists who look at all the evidence, the majority believe that targeting the build-up of amyloid plaques is critical,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “What CMS proposes to do undermines an entire class of treatments aimed at slowing the progression of Alzheimer’s. Patients and doctors want the ability to work together to make treatment decisions based on what works best for individual patients, and CMS should support that. With 1,000 Americans progressing past the reach of these therapies every day, we cannot afford to wait.”

Patient Advocates Call on Congress and White House to Overturn Draft Plan

Patients, their families, and caregivers are weighing in as well, and have sent nearly 20,000 letters to the White House, the U.S. Senate, and the U.S. House of Representatives calling on President Joe Biden and members of Congress to compel CMS to cover this class of drugs according to the label approved by the FDA.

Leading Scientists Urge CMS to Expand Medicare Coverage of these Treatments

Here is what some of America’s leading Alzheimer’s professionals are saying about CMS’ draft coverage decision in their public comments:

• “[T]he CMS decision not to provide Medicare coverage for current and future FDA-approved amyloid antibodies outside of new randomized clinical trials (RCT) that you approve is ill-conceived, impractical for helping many qualified AD patients, based on a flawed summary of basic and clinical evidence on amyloid lowering, and inconsistent with the equitable patient access CMS rightly seeks.” – Dennis Selkoe, MD, Harvard Medical School and Brigham and Women’s Hospital

 

• “The proposed CED (Coverage with Evidence Determination) is the wrong outcome for an agent approved by the FDA. Accelerated approval was based on amyloid plaque lowering considered reasonably likely to predict clinical benefit using the regulatory mechanism defined in the accelerated approval guidance. The point of accelerated approval is to provide access to promising but not completely proven agents while confirmatory data are generated. Of the 14 agents advanced with accelerated approval in 2021, only aducanumab is subject to a CED. The CMS proposal to require clinical trials for approval is inconsistent with the intent of accelerated approval.” – Jeffrey Cummings, MD, ScD, University of Nevada, Las Vegas.

 

• “Limiting access to an FDA approved therapy and specifically applying this restriction to an entire class of as of yet developing therapies will prevent multiple Pharmaceutical companies from considering further exploration of this space and or identifying novel and effective treatments for a disease state with no other disease modifying therapy available to date will have a chilling impact on other companies interest to develop their therapies and will further reduce hope to treat this disease impacting millions of Americans.” – Mark Gudesblatt, M.D., South Shore Neurologic Associates.

“Anti-amyloid treatments aren’t a cure, but they are the first disease-modifying therapy available and offer hope to millions of Americans living with Alzheimer’s,” Vradenburg said. “UsAgainstAlzheimer’s is calling on CMS to reconsider its decision to deny coverage to this entire class of treatments and leave the decision about drug efficacy and safety to those who are qualified and legally authorized to do so.”

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AboutUsAgainstAlzheimer’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.