FDA-approved Alzheimer’s drug likely blocked by CMS’s decision to deny coverage


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

A few months after it’s approved, Medicare and Medicaid will exclude it from people not in the experimental groups. This is a preliminary decision that could affect millions of Alzheimer’s patients.

When Medicare doesn’t cover something, private insurance often follows. It makes people who want access to this drug very uncomfortable.

Gary Longordo said: “I never thought I would talk about an illness like this.

To this day, Longordo has kept his Alzheimer’s diagnosis a secret from everyone but his family.

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

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

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

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

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

The Alzheimer’s Association says this is the beginning of a new era of treatments.

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

Time is especially important now. In January, the Centers for Medicare and Medicaid Services (CMS) made the preliminary decision to cover the drug only for clinical trial participants. Capable of leaving millions, including Gary, with no way to get it.

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

In a review of more than 250 evidence and 41 randomized trials, the agency was not convinced Aduhelm was working. They gave WINK News a partial statement that said: “None of the trials involving any intervention, alone or in combination, have yet to demonstrate a meaningful improvement in health outcomes .”

CMS is encouraging more experimentation. The drug is expensive and some patients have seen serious side effects, including bleeding in the brain and shrinkage. That’s why Gary’s infusion is closely monitored.

Karen said, “There is blood work involved. Related to brain scans. He has a fractured spine. “

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

Gary said: “I believe I can have a normal quality of life because of this opportunity.

If you would like to comment on CMS’ decision to reduce drug use only back into the experimental phase, you can learn how by multiply here.

February 10 is the last day for comment before a final ruling is made in April.

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