7.1 Notification of outcomes of PBAC
Table 7.1 shows the timeframe for notification of PBAC outcomes.
PBAC outcome provided
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 (referred to as the PBAC Minutes) is provided to the sponsor 15 working days after each PBAC meeting. These Minutes provide the basis and rationale for the PBAC outcomes.
The sponsor can accept the PBAC’s recommendation. Refer to Section 8 for the requirements of listing a medicine on the PBS.
The sponsor can decide to not accept the PBAC recommendation. Section 7.1.3 sets out the sponsor’s options in this situation.
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 sponsor 25 working days after the PBAC meeting.
7.1.3 Receipt of a decision to not recommend
Where the PBAC decides to not recommend a submission, written advice (referred to as the PBAC Minutes) is provided to the sponsor 25 working days after the PBAC meeting. This also provides the basis and rationale for the PBAC outcomes.
Sponsors can make another submission to the PBAC (referred to as a resubmission). Information about resubmissions is located in the PBAC Guidelines for preparing submissions to the PBAC. Where the PBAC has already considered a major submission, any resubmission is usually required in the form of a major submission; however, in certain circumstances, in liaison with the PBAC Chair or the department, a minor submission may be accepted.
Sponsors can meet with the PBAC Chair to develop a greater understanding of the PBAC decision to not recommend a major submission (see Section 7.1.5).
Sponsors may seek an independent review of the PBAC decision, if eligible (refer to Section 7.2).
7.1.4 Preparation for resubmission
Sponsors seeking to prepare a resubmission are eligible for a presubmission meeting with OHTA officers if:
- the outstanding issues raised in a resubmission require a substantial rewrite of the submission evidence or revision of the model, and further technical advice from the department would provide useful input that cannot be obtained from another source
- the sponsor is proposing a complex RSA that is integral to the consideration of the PBAC (refer to Section 8.4)
- the sponsor is proposing an MAP that involves prospective collection of evidence as per the draft Managed Access Program Framework.
Refer to Section 4.5 for additional information on, and links to dates allocated for, presubmission meetings.
7.1.5 Procedures for requesting a post-PBAC meeting with the PBAC Chair
Sponsors 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.
Sponsors should email the department to request a meeting (refer to Appendix A for contact details). The dates of these meetings are not set in the calendar of dates. OHTA aims to hold these meetings before the date for receipt of minor submissions to the next PBAC meeting.
Meetings are usually 30 minutes in duration. Officers from OHTA may also attend as requested by the PBAC Chair.
The PBAC Chair and departmental officers do not keep records of the issues discussed at the meeting.
Refer to Section 4.5 regarding attendees and conduct of the meeting. An agenda paper is not usually required, because the PBAC Minutes are considered the agenda papers; however, sponsors may provide a brief document to assist discussion.