23 February 2022 - Some interesting insights from version 1 of the agenda for the May 2022 PBAC (intracycle) meeting.

The first version of the agenda for the May 2022 meeting, published on 11 February 2022, has just three items:

• Faricimab (Vabysmo) - new medicine for patients with age-related macular degeneration and patients with diabetic macular oedema (a submission for each indication/patient population) (Roche)
• Post-market review of medicines for patients wanting to stop smoking - review of report

The agenda may well expand with the addition of items rejected or deferred by the PBAC next month.

One could almost think that the intracycle meeting was established for the sole benefit of Roche. Some may recall that the PBAC was scheduled to consider the report of the post-market review of the medicines for smoking cessation next month.  It has now been put back by two months. 

While the PBAC's consideration of the post-market review was noted in the published agenda for the March meeting, the submissions for faricimab were not.

What is going on here? The initial consideration of a submission for a new medicines by the PBAC at an intracycle (or similar) meeting is most unusual. When was the submission received by the Department? If it was lodged at the time of the cut-off for the March 2022, then why did it not appear in the agenda for the March meeting? If was lodged after the November cut-off, then was Roche given special dispensation.  The Department has not published cut-off date for submissions for intra-cycle meetings. The Department has some non-trivial questions to answer. It could be the start of a new norm.