Alzheimer’s drug approved by the FDA potentially blocked by CMS decision to deny coverage

Reporter: Amy Oshier Writer: Matthew Seaver
Published: Updated:
Alzheimer’s drug Aduhelm.

The excitement was short-lived for people encouraged by a new drug treatment for Alzheimer’s disease.

Months after it was approved, Medicare and Medicaid are excluding it from everyone outside of testing groups. This is a preliminary decision that could affect millions of Alzheimer’s patients.

When Medicare doesn’t cover something, private insurance typically follows. It has people who want access to this drug very upset.

“I never never thought that I would even be talking about a disease like this,” said Gary Longordo.

Up to this moment, Longordo has kept his Alzheimer’s diagnosis a secret from everyone but his family.

Longordo’s wife Karen said, “he’s only known for a few months, but it’s been going on for a lot longer than that.”

“Well, I didn’t notice any symptoms, to be honest with you. She would tell me that I would repeat myself or I would do different things,” said Gary.

He decided to speak up because the drug he is taking is in limbo. “I think it’s helped me in my mental stage and in my physical stage.”

Last June, for the first time in 18 years, the FDA approved a treatment for Alzheimer’s disease. The drug Aduhelm is a monoclonal antibody aimed at amyloid plaques that tangle in the brain. It sticks to the plaque so the body’s immune system can destroy it. It’s approved for early cases.

Amy Schenk, a program manager for the Alzheimer’s Association, said, “it is the first medication that has been shown, shown to slow the progression, which is why it’s such a breakthrough.”

The Alzheimer’s Association feels this is the beginning of a new age of treatments,

Schenk said, “it impacts the trajectory of the disease, which really helps us to be able to give people more time.”

Time is especially important now. In January, the Center for Medicare and Medicaid Services (CMS) made a preliminary decision to only cover the drug for people involved in clinical trials. Potentially leaving millions, including Gary, without a means to get it.

Gary’s wife Karen said, “I think that people are going to fight. And I think they’ll fight hard to get it. Because there is no reason not to try something that’s been approved by the FDA.”

In reviewing more than 250 pieces of evidence and 41 randomized trials, the agency is not convinced Aduhelm works. They gave WINK News a statement saying in part, “No trial involving any intervention, alone or combined, has yet demonstrated a meaningful improvement in health outcomes.”

The CMS is encouraging more trials. The drug is expensive, and some patients have seen serious side effects, including brain bleeds and shrinkage. It is why Gary’s drug infusions are closely monitored.

Karen said, “there’s blood work involved. There’s brain scans involved. He’s had a spinal tap.”

While the CMS is cautious about the drug, the Longordos are not.

“I believe that I could have a normal quality of life because of this opportunity,” Gary said.

If you want to comment on the CMS decision to reduce the use of the drug back to trials only, you can find out how by clicking here.

Feb. 10 is the last day to comment before a final ruling is released in April.

Copyright ©2024 Fort Myers Broadcasting. All rights reserved.

This material may not be published, broadcast, rewritten, or redistributed without prior written consent.