Authors' objectives: These Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee (PBAC Guidelines), version 5.0, assist applicants to prepare a submission to the PBAC for the public funding of a new medicine or medicinal product as part of the Pharmaceutical Benefits Scheme (PBS). The guidelines reflect best practice as far as possible, and seek to maximise the confidence of the PBAC in accepting the many inferences necessarily made in submissions for public funding. They are designed to facilitate the evaluation and translation of the best available comparative clinical evidence for the requested PBS listing, followed by the most appropriate economic evaluation. They also ensure that the predicted use of the medicine in clinical practice is aligned with a standardised Excel workbook to allow these analyses to be presented consistently across submissions. However, although the guidelines present the currently preferred approach to the preparation of submissions to the PBAC, the approach is not prescriptive. Alternative approaches are permitted when adequately justified and supported by data.

Project Status: Completed

Year Published: 2016

URL for published report: https://pbac.pbs.gov.au/content/information/files/pbac-guidelines-version-5.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)