The number of PBAC meetings held each year could be reduced to allow for a longer submission and evaluation process.
Discussions are currently underway between industry and the Department of Health as part of the strategic agreement between government and Medicines Australia.
The agreement includes an entire section on reforms to the PBAC process, significantly focussed on the period leading up to the first submission, with the explicit objective to reduce the resubmission rate by 50 per cent.
The agreement even includes reference to possible "amendments to the PBAC meeting cycle."
According to the agreement, the goal by mid-2018 is to create "revised pathways" for PBAC submissions, including streamlining processes and doubling sponsor access to early advice through two pre-submission meeting.
The "revised pathways" will result in higher cost recovery fees.
Part of the change could be extending the current 17-week submission cycle. It has been changed in the past, from a 12-week cycle in around 2004, when the number of formal PBAC meetings per year was reduced from four to three.
One option is to extend the cycle for major submissions, with just two PBAC meetings per year for majors, with possible retention of more for minor submissions. The committee holds a number of special meetings during the year, in the month after their formal meetings and then as required, and that would continue.
Extending the 17-week cycle for major submissions would allow for more interactions on a submission during the pre-PBAC evaluation process. This might include an extension of the current four week timeframe between consideration by the economic sub-committee and the PBAC. The goal would be to reduce pressure on the process and allow for potential pre-PBAC resolution of issues that might otherwise create cause for a rejection.
A challenge is the duration of PBAC meetings. The external demands on committee members makes any extension of the current three day meeting scheduled problematic.
