Patients will have to participate in registries that collect real-world data on how the drug works as a condition of coverage.
The drug regulator's committee of independent advisors is set to meet on June 9 to discuss the data supporting Eisai's and Biogen's application for the FDA to fully approve Leqembi.
The FDA granted accelerated approval to Leqembi in January, but Medicare severely restricts coverage for Alzheimer's antibody treatments that are cleared under that expedited pathway. The Alzheimer's Association, which lobbies for patients living with the disease, for months has called on Medicare to drop restrictions on Leqembi and fully cover the drug.
Brooks-LaSure told Congress in April a registry "in no way limits people getting access to the drug." She said at the time the goal is to set up the system when the FDA makes its decision on Leqembi on July 6.
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