PBAC process facing major overhaul

Latest News

The Rapid Resolution Process considered by the Pharmaceutical Benefits Advisory Committee at its August meeting is just one part of a potential overhaul that could deliver substantial change to what is a longstanding and institutionalised listing process for medicines.

The committee did not endorse the process at the meeting, for a number of reasons, including that its adoption needs to be considered within the wider context of other potential changes to the PBAC process.

The RRP, developed by Cancer Drugs Access Committee of the Cancer Drugs Alliance, is focussed on the period after a first submission and its rejection by PBAC.

Consideration of change in this part of the process comes as Medicines Australia is about to embark on discussions with the Department of Health over potential changes to the entire PBAC process.

The association's strategic 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.

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.

It includes discussion of the post-rejection process, consistent with the objective of the CDAC proposal, and even the ambitious goal to reduce the time from PBAC recommendation to listing by an average of two months.

The agreement even includes reference to possible "amendments to the PBAC meeting cycle."

One option that has been 'in the ether' for a number of years is to actually reduce the number of formal PBAC meetings each year from three to two. 

It would not be unprecedented because PBAC used to meet four times per year. It was reduced to three last decade to allow more time in the pre-meeting process. Yet the process, underpinned by an economic evaluation, is now far more complex and demanding.

The options to be discussed under the Medicines Australia strategic agreement, which will result in an increase in cost recovery fees, essentially seek to change and introduce new processes within a fixed and highly pressured timeline. Resources will be shifted towards more complex submissions.

Yet the timeline will remain very tight. At present, PBAC sub-committees (Economic and Drug Utilisation) meet four weeks before the PBAC, giving companies, committee members and Department of Health officials, very little time to respond to or resolve identified issues.

Medicines Australia and the Department of Health will shortly hold the first meeting of the working group tasked with developing the proposals into trials. The PBAC is not currently represented on the working group.