Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)

Version 5.0

September 2016

The PBAC Guidelines explain in detail how to prepare a submission to list a new medicine or medicinal product on the Pharmaceutical Benefits Schedule (ie for public funding). The guidelines provide detailed instructions on what information is required by the PBAC and the Economic Sub-Committee (ESC) to support a proposed new medicine, and the most appropriate form of clinical evidence and economic evaluation for specific submissions.

For information on processes, procedures, timelines and documents required, refer to the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme.

Submission structure for submissions requiring evaluation

Section 1 Context Section 2 Clinical evaluation Section 3 Economic evaluation Section 4 Use of the medicine in practice Section 5 Options to present additional relevant information
Section 3A Cost-effectiveness analysis
Section 3B Cost minimisation