7.3 PBAC Outcomes
PBAC Outcomes are published to inform the public about the PBAC’s advice to the Minister for Health. The documents report the PBAC’s decisions in each case and summarise the reasons for the decision. These include PBAC decisions about submissions to list medicines/vaccines on the PBS/NIP, reports on currently listed medicines, general submissions from organisations and individuals, and other matters on the PBAC agenda.
7.3.1 Timeframe for publishing PBAC Outcomes
PBAC Outcomes are published on the Friday afternoon at week 23 of the PBAC cycle.
If a medicine has not completed the TGA review, the outcome will be withheld pending receipt of the TGA delegate’s overview. After receiving this information, the outcome will be added to the outcomes for the respective PBAC meeting on the PBS website.
7.3.2 Preparing the PBAC Outcomes
Applicants preview the PBAC Outcomes, which are compiled from the ratified PBAC Minutes of the meeting by OHTA officers. The outcomes for each submission are forwarded to the applicant on Monday or Tuesday six weeks after the PBAC meeting.
For submissions with a not recommended or deferred outcome, the applicant has the opportunity to provide a comment to be published with the outcome statement. Applicants choosing to provide a comment are required to do so by Wednesday of week 23 of the PBAC cycle.
If the applicant believes that the PBAC Outcome has factual errors, the applicant can request that the PBAC Outcomes be revised.
The department will consider all requested changes before publishing the outcomes. As the outcome statement reflects the PBAC consideration, changes that substantially alter the wording of the decision or the intention of the PBAC will not be accepted by the department.