- 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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- SECTION 5/
- 5 1 ISSUES INFLUENCING DECISION MAKING
5.1 Issues influencing decision making
Page last updated: September 2016
If applicable, provide relevant information not captured in the submission that may influence PBAC decision making. Refer to ‘Key factors influencing decision making by the PBAC’ in the introduction to these guidelines. For example, discuss how the proposed medicine might promote (or hinder) patient equity or access.