Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?

The new data for Eisai Co., Ltd./Biogen, Inc.’s Alzheimer’s candidate lecanemab appears sufficient to win FDA approval despite its safety signals, but whether the results are sufficient to clear the next critical hurdle – Medicare reimbursement – remains an open question.

In its final Medicare national coverage determination (NCD) limiting reimbursement for Alzheimer’s drugs to patients enrolled in a study, the Centers for Medicare and Medicaid Services said it could adjust the restrictions once the drugs are supported by solid evidence of clinical cognitive benefit