7.1 Notification of outcomes of PBAC
Table 7.1 shows the timeframe for notification of PBAC outcomes.
|
Timeframe |
PBAC outcome provided |
|---|---|
|
One week after PBAC meeting |
Emailed advice of type of PBAC outcome including any PBAC nominated pathways (recommended and not recommended submissions) |
|
Three weeks after PBAC meeting |
Ratified PBAC Minutes for positive recommendations by email (Section 7.1.1) |
|
Five weeks after PBAC meeting |
Ratified PBAC Minutes for deferred and not recommended submissions by email (Sections 7.1.2 and 7.1.3) |
7.1.1 Receipt of positive recommendation
For a positive recommendation, written advice (the PBAC Minutes) is provided to the applicant on Friday of week 20 of the PBAC cycle (three weeks after PBAC meeting). These Minutes provide the basis and rationale for the PBAC outcomes.
Requirements for listing a medicine on the PBS are outlined in Section 8. Applicants who are seeking PBAC reconsideration of a Recommendation are required to follow the processes outlined in Section 5.7.
7.1.2 Receipt of deferral of a recommendation
For deferrals of a recommendation by the PBAC, written advice (the PBAC Minutes) is provided to the applicant on Friday of week 22 of the PBAC cycle (five weeks after PBAC meeting).
The PBAC will defer making a decision where there is specific or missing information that cannot be obtained from the applicant and is required for PBAC decision-making (e.g. TGA delegate’s overview or MSAC advice in relation to a codependent technology).
Applicants who receive a deferred outcome are not required to provide any further information for the subsequent PBAC consideration. Applicants will be advised of the outcome once the PBAC has received the required information and has made a decision.
7.1.3 Receipt of a decision to not recommend
Where the PBAC decides to not recommend a submission, written advice (the PBAC Minutes) is provided to the applicant on Friday of week 22 of the PBAC cycle (five weeks after PBAC meeting). This also provides the basis and rationale for the PBAC outcomes.
Applicants can meet with the PBAC Chair to:
- develop a greater understanding of the PBAC decision to not recommend a submission (see Section 7.1.4)
- discuss a PBAC nomination for a Facilitated Resolution Pathway (see Section 9.4)
Applicants may seek an independent review of the PBAC decision, if eligible (refer to Section 7.2).
Applicants choosing to lodge a resubmission are required to follow the processes outlined in Section 9.
7.1.4 Procedures for requesting a post-PBAC meeting with the PBAC Chair
Applicants who have received a decision to ‘not recommend’ may request a meeting with the PBAC Chair to develop an understanding of the reasons for the PBAC decision.
The PBAC Chair has the discretion to offer a post-PBAC meeting for positive recommendations. It is expected that this meeting would provide the applicant with additional context and information on the recommendation to enable the applicant to proceed to a pricing pathway. The PBAC Chair remains unable to change the recommendation of the PBAC.
Applicants should email the department to request a meeting (refer to Appendix A for contact details). The dates of these meetings are set in the PBS calendar and occur on Tuesday and Wednesday of week 23 (six weeks after the meeting).
Refer to Section 4.4 regarding attendees and conduct of the meeting. In addition to the PBAC Chair and the PBAC Deputy Chair, officers from OHTA may also attend as requested by the PBAC Chair.
Meetings are usually 30 minutes in duration. To assist with preparations for the meeting, applicants are requested to submit a one-page outline of the matters proposed for discussion at the meeting. The outline should include sufficient information to ensure the matters for discussion are clear. No new data will be considered or discussed. The PBAC Chair and departmental officers do not keep records of the issues discussed at the meeting.
