FDA narrows use for controversial new Alzheimer’s drug after criticism

The Food and Drug Administration (FDA) on Thursday approved an update to the prescribing label for a controversial new Alzheimer’s drug in an attempt to narrow its intended use.

The agency recommended that Biogen’s Aduhelm drug should only be used in patients with mild Alzheimer’s dementia or mild cognitive impairment, a departure from the initial approval that was much broader.

The change, which was announced by Biogen, emphasizes that the drug was only studied in people with mild forms of the disease. It makes clear “there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

What it means: The narrow label could make it cheaper for Medicare to cover the drug, which was priced at a staggering $56,000 a year per patient.

Physicians and drug pricing advocates criticized the high cost and broad approval, saying it could wreak havoc on Medicare spending, especially for a drug that had an unproven benefit.

Still really expensive: Under the narrower label, the company has estimated about 1.5 million people with mild Alzheimer’s would be eligible for the drug.

But total Medicare spending for all prescription drugs was $37 billion in 2019. That amount could be blown out of the water if Medicare paid for all eligible patients.

The controversy: It’s extremely rare for a company to change a drug’s indication so soon after getting approval. But the decision to narrow the label was started at FDA. Agency officials approached Biogen and initiated meetings with the company to clarify labeling. Critics said the move by FDA is an attempt to clean up a mess of its own making.