April 02, 2022

The Continued Fight Between Medicare and Alzheimer’s Association for New Treatment

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The debate between the Alzheimer’s Association and the U.S. federal government over a potential treatment for Alzheimer’s disease took another turn in March 2022, as the Centers for Medicare and Medicaid Services (CMS) announced that the drug Aduhelm will only be covered by Medicare for those who receive it as part of a clinical trial.

This is despite the U.S. Food and Drug Administration (FDA) approving the treatment for approximately 1.5 million eligible people.

Centers Health Care has a look at the debate from both sides and what the potential next steps are regarding the treatment.

What Is Aduhelm?

Aduhelm, the name for the drug aducanumab created by Biogen, was approved by the FDA a year ago, but trial data just came out in early 2022.

The drug is given in the form of an infusion of monoclonal antibodies on a monthly basis. It is designed to slow the progression of Alzheimer’s by trying to reduce the production of amyloid, an abnormal protein that is produced in bone marrow and ends up in the brain of dementia patients.

Why the Controversy?

It seemed to start in June 2021, when in the FDA approval process, the agency said that it was unclear if the drug was beneficial. It was initially authorized for those with mild cognitive decline due to Alzheimer’s.

In addition, clinical trials found that some patients had a slowing of cognitive decline, but patients in another one found no difference. Brain swelling or bleeding was also a side effect reported by around 40% of people in one study.

Also complicating matters is the fact that some researchers believe that reducing the amyloid protein won’t make a difference when it comes to slowing down cognitive decline.

The Alzheimer’s Association’s Stance

While Medicare denied full coverage due to these questions, the Alzheimer’s Association argues that Medicare has always covered FDA-approved treatments for cancer, heart disease, and HIV/AIDS. The group is also concerned that the decision will also be automatically handed down to other similar drugs that are coming down the pipeline.

Medicare, however, said that each drug will be considered on its own merits and results of clinical trials, which is a minor win for advocates of Aduhelm because decisions on a certain drug are typically applied to other similar drugs.

A drug typically needs two convincing clinical trials to win full FDA approval, so the news on these potential Alzheimer’s treatments could change rapidly.

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