- PBAC Guidelines
- Submission structure for submissions requiring evaluation
- Submission executive summary
- Section 1 Context
- Section 2 Clinical evaluation
- 2.1 Literature search methods
- 2.2 Identify relevant trials
- 2.3 Trial design and execution
- 2.4 Trial characteristics
- 2.5 Trial results: whole trial population
- 2.6 Trial results: additional analyses
- 2.7 Assessment of differences between the trial setting and the Australian setting after listing
- 2.8 Interpretation of the clinical evidence
- Section 3 Economic evaluation
- Section 3A Cost-effectiveness analysis
- 3A.1 Overview and rationale of the economic evaluation
- 3A.2 Computational methods and structure of the economic analysis
- 3A.3 Population and setting
- 3A.4 Model transition probabilities or variables, transformation and extrapolation
- 3A.5 Health outcomes
- 3A.6 Health care resource use and costs
- 3A.7 Model validation
- 3A.8 Results of the base-case economic evaluation
- 3A.9 Uncertainty analysis: model inputs and assumptions
- Section 3B Cost minimisation
- Section 4 Use of the medicine in practice
- 4.1 Justification of the selection of data sources
- 4.2 Estimation of use and financial impact of the proposed medicine
- 4.3 Estimation of changes in use and financial impact of other medicines
- 4.4 Estimated financial impact for the PBS/RPBS or the NIP
- 4.5 Estimated financial implications for the health budget
- 4.6 Identification, estimation and reduction of uncertainty
- 4.7 Quality use of medicines
- Section 5 Options to present additional relevant information
- Requests for Product Types
- Appendixes
- Appendix 1 Expert opinion
- Appendix 2 Literature search methods
- Appendix 3 Identify relevant trials
- Appendix 4 Heterogeneity of treatment effect across studies
- Appendix 5 Translating comparative treatment effects of proposed surrogate measures to target clinical outcomes 194 Introduction
- Appendix 6 Including nonhealth outcomes in a supplementary analysis
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Page last updated: 3 November 2024
Forms that may be required to list a medicine on the Pharmaceutical Benefits Scheme can be found on the PBS website.