WASHINGTON, D.C. — Despite recent FDA approval, new Alzheimer’s treatments- which experts say that can slow the progression of the disease- are not accessible to many Americans.
More than six million Americans are living with Alzheimer’s disease. That number is not expected to decrease anytime soon.
“Over the next two decades or so, it’s going to more than double,” said Dr. Kenneth E. Thorpe, Ph.D, Professor and Chair of the Department of Health Policy and Management, in the Rollins School of Public Health of Emory University.
According to Dr. Thorpe, as the number of Alzheimer’s patients grows, so does the cost to the U.S.
“We spend collectively about $355 billion a year to manage and treat Alzheimer’s,” said Thorpe who also serves as Chairman of the Partnership to Fight Chronic Disease.
Last July, the FDA approved two promising treatments to slow the progression of the disease.
“Two new medications, that have come through their process that they have found to be safe and effective and also to reduce the buildup of plaque in the brain, which is sort of the hallmark of identifying dementia and Alzheimer’s,” said Thorpe.
The approval is great news in the fight to treat early onset dementia. However, the bad news is the treatments are only covered by Medicare if the patient is enrolled in a clinical trial.
“This is unprecedented and highly unusual, for a public program like Medicare to not reimburse for an FDA approved medication that’s shown tremendous clinical progress,” said Thorpe.
Thorpe says the decision can impact innovation for chronic disease treatment.
“This decision could really hinder the incentives to innovate,” said Thorpe.
Additionally, Thorpe says slowing the progression of Alzheimer’s reduces the burden on family care givers and can lower costs across the board.
“To reduce the number of months that a patient is in a memory loss center or a skilled nursing facility saves the patient’s family money and will save Medicare money on the nursing facility side,” said Thorpe.
A bipartisan group of lawmakers have signed a letter to CMS, calling for changes to Medicare’s coverage of these Alzheimer’s treatments.
A CMS spokesperson shared the following statement:
“Alzheimer’s disease is a devastating illness that affects millions of Americans and their families. CMS is committed to helping people get timely access to treatments and improving care for people with Alzheimer’s disease and their families.
Broader Medicare coverage has been available for Leqembi since the Food and Drug Administration’s (FDA) move to grant traditional approval to the drug that treats individuals with Alzheimer’s disease. In July 2023, CMS began offering broader Medicare coverage for Leqembi (the brand name for lecanemab) under the National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease through the Anti-Aβ mAb Coverage with Evidence Development (CED) Study after the FDA granted traditional approval to the drug for the treatment of individuals with Alzheimer’s disease.
Under the NCD, to receive Medicare coverage for Leqembi, or any other anti-amyloid mAb that receives traditional approval from the FDA, people need to: 1) be enrolled in Medicare Part B; 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia; and 3) have a physician who participates in a qualifying study with an appropriate clinical team and follow-up care. CMS established a National Patient Registry where clinicians participating in the Anti-Aβ mAb CED Study only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.”
