There are now two Alzheimer’s treatments with significant clinical benefit. It’s not clear how quickly patients will be able to benefit.
Nurse Christine Besso, center, helps Robert Williford, 66, during his first session of receiving the Alzheimer’s treatment Leqembi while Williford’s wife, Cynthia Byron-Williford, 59, watches at Abington Neurological Associates in Abington, Pennsylvania, on Nov. 7, 2023. ended in failure.
Eisai’s Leqembi received FDA approval more than a year ago after demonstrating a 27% decline in early disease progression; donanemab achieved 35%. But rather than cover the drug for seniors who need it, the Centers for Medicare and Medicaid Services , which administers Medicare, restricted access, citing the very safety concerns the FDA scrutinized before granting approval.
Though the FDA reviewed the data and determined lecanemab’s benefit outweighed the risks, CMS continues to press for more data on its clinical benefit and safety. The agency isn’t supposed to consider cost in a coverage decision, but that certainly seems to be a factor.
, who must enter patient data in an approved registry or study to secure Medicare coverage. This adds an uncompensated layer of bureaucracy to the management of a disease that is already very complex to diagnose and treat. CMS maintains that its digital database is easy to use, but the policy is disconnected from the reality on the ground.
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