Table of contents
Page last updated: September 2016
- Foreword
- Record of updates
- Abbreviations and acronyms
- About the guidelines
- Who uses the guidelines?
- Structure of a submission to the PBAC
- Structure of the PBAC Guidelines
- Key factors influencing decision making by the PBAC
- Key points for preparing a PBAC submission
- Associated documents
- Contact details
- Document table
Part A – Guidelines for preparing the main body of a submission
Section 1 Context
- Introduction
- 1.1 Clinical issue addressed by the submission
- 1.2 Clinical management
- 1.3 Regulatory process
- 1.4 Proposed PBS listing
Section 2 Clinical evaluation
- Introduction
- 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
- Introduction
- 3A.1 Overview and rationale of the economic evaluation
- 3A.2 Computational methods and structure of the economic evaluation
- 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
- Introduction
- 3B.1 Overview and rationale for the cost-minimisation approach
- 3B.2 Estimation of equi-effective doses
- 3B.3 Additional costs and/or cost offsets
- 3B.4 Results
Section 4 Use of the medicine in practice
- 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
- Introduction
- 5.1 Issues influencing decision making
- 5.2 Supplementary analyses
- 5.3 Prudent-use principles for antimicrobial agents
- 5.4 Basis for any claim for the ‘rule of rescue’
Part B – Information requests for specific product types
Product type 1 – Fixed-dose combination products
Product type 2 – Nutritional products
- Product type 2 – Nutritional products
- P2.1 Details of proposed product and its comparators (Section 1)
- P2.2 Clinical evaluation (Section 2)
Product type 3 – Vaccine products
- Product type 3 – Vaccine products
- P3.1 Details of the proposed vaccine and its comparator (Section 1)
- P3.2 Clinical evaluation (Section 2)
- P3.3 Economic evaluation (Section 3)
- P3.4 Budgetary implications (Section 4)
Product type 4 – Codependent technologies
- Introduction
- P4.1 Overview of information requested in codependent submissions
- P4.2 Specific codependent technology information requests
- Section 1 – Context
- Section 2 – Clinical evaluation
- Section 3 – Economic evaluation
- Section 4 – Use of the medicine in practice
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
- Appendix 6 Including nonhealth outcomes in a supplementary analysis
- References