15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look at the early resolution resubmissions for 2022.

As their name implies, submissions nominated by the PBAC for early resolution following a rejection or deferral should otherwise be resolved quickly. (i.e. they should be recommended soon after).

Applicants who accept the early resolution pathway are eligible for PBAC consideration out-of-session (before the main meeting), unless the department, in consultation with the PBAC Chair, identifies an unexpected issue such that the resubmission needs consideration at the next main PBAC meeting.

The PBAC only nominated one submission (medicine) for early resolution in March this year. Burosomab was rejected for the second time in March but was recommended soon after at the May intracycle meeting.

Interestingly, the PBAC considered an early resolution resubmission from MSD for pembrolizumab at the March meeting.  It was deferred rather than being recommended; MSD was clearly not impressed. The PBAC considered and recommended a second resubmission at the May intracycle meeting.

Four submissions (medicines) were nominated by the PBAC for early resolution in July:

• Azacitidine
• Ruxolitinib phosphate
• Trastuzumab deruxtecan
• Vosoritide

Azacitidine, ruxolitinib phosphate and vosiritide were all considered by the PBAC at this month's intracycle meeting. The outcomes for this meeting have not yet been made public.

Trastuzumab deruxtecan did not appear on the agenda for the September meeting, nor has it appeared on the agenda for the November meeting. Could it be a late addition?  Watch this space.