Not Recommended outcome for a PBAC Submission

The Government cannot list a medicine or modify a listing on the PBS without a PBAC recommendation to do so. A ‘not recommended’ PBAC outcome does not necessarily represent a final view about the merits of the medicine. Applicants are able to lodge another submission (referred to as a resubmission) to a future PBAC meeting for the same medicine to address the issues identified by the PBAC (outlined in the PBAC Minutes). The resubmission may include new data to support the claimed benefits of the medicine, or otherwise change aspects of the PBS listing application.

For submissions with a ‘not recommended’ outcome, the applicant is able to provide a comment on this outcome. The comment is available with the PBAC outcome on the PBS website six (6) weeks after the PBAC meeting. The specific reasons for each PBAC decision are available in the Public Summary Documents published on the PBS website approximately four (4) months after the PBAC meeting.