Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee

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 Pharmaceutical Benefits Advisory Committee (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.

Submission structure for a major submission

Section ADescribes the proposed medicine, its intended use on the PBS, and the therapy likely to be most replaced by prescribers in practice (the ‘main comparator’). Section BProvides the best available evidence comparing the clinical performance of the proposed medicine with the main comparator, preferably from direct randomised trials. Section CDescribes the methods used in premodelling studies to modify, or ‘translate’ the results of the clinical evaluation to the context of the requested listing. Section DPresents an economic evaluation of substituting the proposed medicine for the main comparator in the context of the listing requested. Section EIncludes extent of use and financial analyses for the PBS/Repatriation Pharmaceutical Benefits Scheme and government health budgets. Section FIncludes information about quality use of medicines, risk-sharing arrangements and other relevant information to support your submission.
summary Context Clinical Evaluation Translation Economic evaluation Bugetary Implications Other information
Details of proposed medicine and main comparator Systematic review of clinical evidence. Adapt clinical results for economic evaluation. Cost utility analysis. Cost minimilisation analysis. Epidemiological and/or market share analysis Quality of medicines. Risk sharing arrangements. Other relevant factors.