Aduhelm’s Revised Labeling Could Help Payers Navigate Reimbursement

The US Food and Drug Administration has revised labeling for Biogen, Inc.'s Aduhelm (aducanumab) to better clarify how it should be used in Alzheimer's patients one month after the drug was approved in the US and following some backlash from legislators, physicians and health care spending watch dogs. The new language could help balance potential broad use and a high price tag in payer negotiations.

The updated labeling was announced on 8 July, updating the indication section to better clarify that the drug should be used in patients with mild cognitive impairment or mild dementia,...