12 September 2022 - We compare and contrast the submissions nominated by the PBAC in March for an early re-entry resubmission.

The PBAC nominated four medicines for this pathway:

• Cannabidiol
• Enfortumab vedotin
• Pegcetacoplan
• Vericiguat

According to the PBAC "an Early Re-entry Pathway may be nominated by the PBAC where the PBAC considers that the remaining issues could be easily resolved and the medicine or vaccine does not represent high added therapeutic value for the proposed population. Applicants who accept this pathway are eligible for PBAC consideration at the immediate next meeting."

Does this mean the next scheduled meeting or the next meeting (i.e. the next intracycle meeting)?

The Public Summary Documents for these four medicines all make the following statement "the early re-entry resubmission must be lodged by week 7 of the current PBAC cycle or the next cycle. If the issues cannot be addressed by the sponsor in a simple resubmission and the early re-entry timing is not acceptable, a standard re-entry pathway is available."

The key points here are that the resubmission must be lodged by week 7 of the current cycle or the next cycle.  If the resubmission is not lodged by the week 7 of the current cycle, then must it be lodged by week 3 of the following cycle or can it be lodged by week 7? Again this is not clear.  Are there any penalties if a resubmission is not lodged by the following cycle?

Let's examine the timing of the early re-entry resubmissions for the four medicines:

• Cannabidiol - early re-submission was lodged by week 7 of the then current cycle and considered by the PBAC in July
• Enfortumab vedotin - early-resubmission was lodged by week 7 of the following cycle and will be considered by the PBAC in November
• Pegcetacoplan -  early re-submission was lodged by week 7 of the then current cycle and considered by the PBAC in July
• Vericiguat - early re-submission was lodged by week 7 of the then current cycle and considered by the PBAC in July

It is therefore seem possible to lodge an early re-entry resubmission by week 7 of the cycle for the next scheduled PBAC meeting. Nonetheless, the Department could provide more clarity to applicants on the timelines for early re-entry submissions. 

We will revisit this issue with a review of the medicines nominated by the PBAC in July for the early re-entry resubmission pathway in a future issue of MAESTrO Daily.