Friday, June 23, 2023

Very Brief Blog: AAN Resubmits Complaint about Amyloid Drugs NCD

With the initial accelerated approval of an Alzheimer's amyloid drug CMS wrote a controversial NCD that it wouldn't cover it (outside a phase 4 RCT).   In early 2023, American Academy of Neurology and other stakeholders asked CMS to revisit that, and it said "nope."

Less well known, on June 12, 2023, AAN again asked CMS to reconsider the NCD.  As far as I know, there's no reply yet.  Here's the nine-page, June 12, AAN letter to CMS.

Tidbit - the letter is addressed to Ms. Syrek-Jensen as head of Coverage; she's now moved to a different position in the CMS quality and coverage division.

This week, CMS announced that it would require a bare-bones clinical registry (with fields like doctor name, patient name, and drug name) via a portal it will open as soon as Leqembi gets FDA full approval (any day now).  I wrote two brief blogs about the registry announcement.

Blog #1 - Amyloid tests in the registry.
Blog #2 - Data in the registry.