FDA Now Says New Alzheimer’s Drug Should Have Limited Use. What Are the Implications?

• The Food and Drug Administration is limiting the use of the drug Aduhelm to treat Alzheimer’s disease.
• It’s now being recommended only for people in the early stages of the disease.
• Medical professionals and officials at the Alzheimer’s Association say they support the limitations.

Following pushback and resignations over the decision to approve the use of Aduhelm to treat Alzheimer’s disease, officials at the Food and Drug Administration (FDA) have now narrowed their recommendations for the drug to only be used to treat people in the early stages of the disease.

That pullback came just weeks after the approval of the drug, the first approved to treat Alzheimer’s in 18 years.

Medicare has also just launched a review on how — and if — they should cover the cost of the drug.

That review, a seldom-used process called “coverage determination,” will consider Aduhelm’s usefulness along with its price tag, said to be as high as $56,000 a year.

That decision could reduce access to the drug even more.