Posted by Michael Wonder on 17 Jul 2023
Novel Alzheimer disease treatments and reconsideration of US pharmaceutical reimbursement policy
17 July 2023 - While donanemab appears to be among the first therapies to demonstrate measurable clinical benefit for Alzheimer's disease, it is also associated with statistically significant and potentially important adverse effects (again, similar to lecanemab).
Concern about adverse effects may be part of the rationale for a June 2023 CMS' National Coverage Determination that will require patients to be enrolled in a registry for monoclonal antibody treatments for AD that receive traditional (as opposed to accelerated) approval to be covered under Medicare.
