Washington, D.C. (March 1, 2022) – “He did it again. From his victory speech in November 2020 and then again in his initial address to the nation in 2021, and then tonight in his most major address yet unveiling his ‘Unity Agenda,’ President Biden put Alzheimer’s disease near the top of the U.S. national public health agenda for the first time in our country’s history. The President promised to address the Alzheimer’s public health crisis in the U.S. and improve access to life-improving Alzheimer’s therapies for all Americans.
“President Biden was committed, determined, and hopeful about beating this complex and heartbreaking disease that impacts more than six million Americans and their families. As he declared victory on that cold November night he said, ‘We’re always looking ahead…ahead to an America that cures disease(s) like cancer and Alzheimer’s.’ Only two months later he stated again, “…here’s what it would do: It would have a singular purpose, to develop breakthroughs to prevent, detect and treat diseases like Alzheimer’s, diabetes, and cancer.’
“Three times now, the President gave the country his promise and his administration a clear directive to act against Alzheimer’s disease.
“And yet despite the President’s concern for people with Alzheimer’s and commitment to cure the disease the Centers for Medicare and Medicaid Services (CMS)appears set to break President Biden’s promise to the American people. The agency’s preliminary decision to delay and restrict coverage for an entire U.S. Food & Drug Administration (FDA) approved class of drugs — monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease — stands in direct opposition to the President’s commitment to address Alzheimer’s directly.
“This decision, should it stand, is nothing but a modern-day Trojan Horse.
“In June of 2021, the first Alzheimer’s disease modifying treatment was approved by the FDA. There is no historical or statutory precedent for CMS to block Medicare coverage of an approved drug, and all other drugs of its class now and in the future, for use according to the FDA label. The only explanation is that CMS allowed the potential cost for the federal government that would result from the coverage of the drug to drive its decision-making, which is highly illegal.
“Ironically, CMS is being brazenly short-sighted when it comes to cost and has put itself at ground zero in the Washington political debate on drug pricing — using vulnerable seniors as a political weapon against pharma. Here are the facts: There are over six million people with Alzheimer’s in the U.S. and the FDA approved drug is expensive. When considering treatments for other serious diseases (some cancers, Cystic Fibrosis, MS, etc.), while the drugs may be similarly priced, the size of the population to be treated or considered is significantly lower. Some are as low as 10,000.
“Fast forward to 2050 when there will be more than 14 million people with this disease and fewer drugs than anyone intended because President Biden’s directive ‘to develop breakthroughs to prevent, detect and treat diseases like Alzheimer’s, diabetes, and cancer’ has been largely ignored. Did the CMS make the right decision? Absolutely not. If not reversed, this CMS decision will be responsible for millions of lives lost and a destructive financial burden on families and the health care systems caused by refusing to address Alzheimer’s in its earliest stages. The taxpayer weight of long-term care for millions of people living with Alzheimer’s is far greater than the cost of a treatment for the earliest stages of the disease.
“CMS’ decision is robbing our country of critical future public health investments while allowing Alzheimer’s disease to continue to rob our loved ones of the opportunity to live longer, more productive and enriched lives, and more importantly it robs them of the opportunity to make informed choices for themselves while they are able.
“The CMS will deliver its final ruling on this FDA-approved class of drugs on April 11th and has the chance to live up to the President’s commitment of delivering new treatments and therapies to improve equity in care for people with Alzheimer’s and their families. Reversing this decision is imperative for people today and our economy tomorrow.
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About the Global Alzheimer’s Platform Foundation® (GAP)
The Global Alzheimer’s Platform Foundation® (GAP) is a person-centric nonprofit dedicated to accelerating the delivery of innovative therapies for neurological disorders by reducing the duration and cost of clinical trials. Research centers across the US, Canada, and Europe are part of the growing GAP Network (GAP-Net). GAP supports GAP-Net research centers by assisting with study start up and recruitment activities, promoting diversity in research studies, and offering international clinical trial infrastructure, resources, and programs that champion brain health and the citizen scientists who make research possible.