Monday, June 28, 2021

HHS: July 19: Meeting on "Implications Posed by Aducanumab" for Alzheimer's; PLUS "Closed-Door" Meeting at Duke

Update - A rough computer generated transcript is in the cloud, here.


HHS First Meeting on Aduhelm  - July 19, 2021

The Department of Health and Human Services has a longstanding Advisory Council on Alzheimer's Research, Care, and Services.

The Council will meet to discuss "the implications and opportunities presented by the approval of aducanumab [Aduhelm] on July 19, 2021.   A very brief meeting announcement has been posted in the Federal Register.

  • See the home page for the Council here.
  • See the agenda page for all meetings, here.
  • The last meeting was on May 5, 2021 here.
  • See the placeholder webpage for the new July 19 meeting here.
  • See the Federal Register webpage for the meeting announcement, here.
  • The prepublication PDF is here, the Federal Register paginated announcement is to appear June 29.
The meeting will be held on July 19, 2021 from 12:30pm to 4:30pm EST.  The meeting will be virtual, streaming live at  Public comments will be allowed (2 minutes) from 4 to 4:30 pm.  Register to comment by emailing  Please submit your written copy of oral comments by July 20.   Alternatively, submit written comments only to the same email.

As stated above, the only remark on Aduhelm is a brief phrase, "the implications and opportunities presented by the approval of aducanumab" will be considered.

"Duke to host private meeting with payers and biopharma on how to pay for Alzheimer's drugs"

Separately, Endpoints reports that "at the request of the FDA" the Duke-Margolis Center for Health Policy will hold a "closed door meeting" to discuss "to convene public and private payers, clinicians, academics, patient groups, and industry" to discuss "coverage and evidence challenges" for A-beta drugs as a class.   It's unusual for FDA to go very far in convening meetings on "coverage" and they usually take themselves to be their own gold standard for "evidence."  Article here.