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.


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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 www.hhs.gov/live.  Public comments will be allowed (2 minutes) from 4 to 4:30 pm.  Register to comment by emailing NAPA@hhs.gov.  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.


Headline:
"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.