7.3 PBAC Outcomes

Page last updated: October 2016

The PBAC has published its decisions since June 2003, excluding advice related to price only.

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, 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 six 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

Sponsors preview the PBAC Outcomes, which are compiled from the ratified PBAC Minutes of the meeting by PEB officers. The outcomes for each submission are forwarded to the sponsor on Monday or Tuesday six weeks after the PBAC meeting.

Sponsors have one to two working days to review the outcome statements. For medicines that the PBAC did not recommend or deferred making a recommendation on, the sponsor is asked to provide a comment, which is published with the outcome statement. Sponsors provide their comments by email (refer Appendix A for contact details).

If the sponsor believes that the PBAC Outcome has factual errors, the sponsor 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.

 

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