Myth vs. Fact: CMS Draft Decision on Alzheimer’s Drugs
Washington, D.C. (January 19, 2022) – With so much misinformation surrounding the draft National Coverage Determination (NCD) from the Centers for 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.
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.