Donanemab In Medicare: Quick Reversal Of Alzheimer’s Coverage Limits Doubtful, Lilly Says

Eli Lilly and Company expects its donanemab to get an accelerated approval from the US Food and Drug Administration in Alzheimer’s disease early next year but is not counting on much in the way of sales during the balance of 2023 because Medicare coverage restrictions will be a continuing challenge, according to company executives.

Lilly has expressed confidence in the past that it will have the data that can convince the Centers for Medicare and Medicaid Services to reconsider its seven-month old national coverage determination for amyloid-directed monoclonal antibodies for Alzheimer’s disease, which restricts Medicare coverage to patients enrolled in a study