The Centers for Medicare and Medicaid Services (CMS) made an extraordinary announcement on January 11 when the agency said it intended to deny coverage for not just one drug to treat Alzheimer’s, but an entire class, unless Medicare participants participate in highly restrictive clinical trials.
Anti-amyloid monoclonal antibodies are a class of Alzheimer’s treatment that work by lowering amyloid in the brain, which has been associated with slowing cognitive decline in individuals. This treatment approach is particularly effective for people in the early stages of dementia. UsAgainstAlzheimer’s strongly opposes the draft CMS coverage decision, which affects not only Aduhelm, the first and only drug in this class currently approved by the Food and Drug Administration, but multiple therapies under development and in line for FDA review and potential approval.
The Centers for Medicaid and Medicare Services (CMS) has proposed a new Medicare coverage decision that effectively would block millions of Americans from getting access to life-changing treatments to treat Alzheimer's.
What this new draft proposal would actually do is create barriers to FDA approved therapies for people who have historically been excluded from clinical trials, including African Americans, Latinos, and low-income families.
Press Release
Medicare Slams the Door on Alzheimer’s Treatments
The Centers for Medicare and Medicaid Services (CMS) announced today that it planned on covering anti-amyloid treatments (such as Aduhelm) under what is known as a Coverage with Evidence Development (CED). The agency’s decision effectively denies access to an entire class of drugs for years to come and further exacerbates health disparities.
“This is absolutely unacceptable. If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs—not by the agency that regulates drugs but by the federal insurance bureaucracy. Why are treatments for Alzheimer’s patients being held to a different standard than those treating cancer, HIV, and other illnesses? Is it because there are so many of us? Is it because we’re old? CMS should be ashamed of the way it is discriminating against this one group of patients.”
George Vradenburg
Co-Founder and Chairman, UsAgainstAlzheimer's
Press Release
UsAgainstAlzheimer’s Urges CMS to Revise Plan that would Deny Medicare Coverage of FDA-approved Alzheimer’s Drugs
“The proposed NCD is anti-patient, anti-science, and anti-Food and Drug Administration (FDA),” UsAgainstAlzheimer’s wrote in a comment letter on the draft plan. “The proposed decision would effectively deny access for millions of Americans to the entire class of the first-ever disease-modifying therapies for Alzheimer’s disease (AD)."
Myth vs. Fact: CMS Draft Decision on Alzheimer’s Drugs
With so much misinformation surrounding the draft National Coverage Determination (NCD) from the Centersfor Medicare and Medicaid Services (CMS) not to cover the first class of Alzheimer’s drugs, except in very limited circumstances, UsAgainstAlzheimer’s is setting the record straight.
Myth: The draft determination applies only to a single drug: Aduhelm.
Fact: CMS leadership has repeatedly confirmed the draft NCD applies to the entire class of anti-amyloid monoclonal antibodies. It impacts promising drugs in late-stage development from Eisai Co., Eli Lilly &Co, Roche, and even Alzheimer’s drugs not invented yet.
Myth: This is a normal exercise of CMS authority.
Fact: CMS has never refused to cover an on-label use of any FDA-approved therapeutic drug or decided in advance to deny coverage for an entire class of drugs. Prior use of Coverage with Evidence Development has been confined almost exclusively to medical devices.
Myth: The proposed decision protects the public.
Fact: Alzheimer’s is a fatal disease, not occasional memory slips that are the normal part of aging. It is the 6th leading cause of death among Americans. No alternative treatments exist to slow progression of the disease. CMS, the nation’s health insurance agency, is telling Alzheimer’s patients it will effectively deny coverage for every drug in a class, regardless of the safety and efficacy those drugs show in FDA trials.
Myth: Patients will still have access; they just have to participate in clinical trials.
Fact: Scientists estimate approximately 1.2 million Americans might benefit from this class of drugs. Clinical trials typically enroll no more than 3,000 people, making these drugs unavailable for nearly every Medicare patient who might benefit.
Myth: This is only a short delay.
Fact: This draft decision is so unprecedented it is impossible to state definitively how long patients must wait. Some clinical trial experts estimate the NCD would delay patient access to these drugs until 2032 or later. Scientists agree these treatments are most effective in the early stages of the disease, so years of delay will mean it will be too late for hundreds of thousands of patients.