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Department of Health and Aged CarePBAC Guidelines
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  • PBAC Information
      About the Guidelines Contents
  • Submission structure for submissions requiring evaluation
      Submission executive summary Section 1 Context Section 2 Clinical evaluation Section 3 Economic evaluation Section 3A Cost-effectiveness analysis Section 3B Cost minimisation Section 4 Use of the medicine in practice Section 5 Options to present additional relevant information
  • Requests for Product Types
      Product type 1 – Fixed-dose combination products Product type 2 – Nutritional products Product type 3 – Vaccine products Product type 4 – Codependent technologies
  • 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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    • Abbreviations and acronyms
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  • Submission structure for submissions requiring evaluation
    • Submission executive summary
    • Section 1 Context
      • 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
      • 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
      • 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
      • 4.1 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
      • 5.1 Issues influencing decision making
      • 5.2 Supplementary analyses
      • 5.4 Basis for any claim for the ‘rule of rescue’
      • 5.3 Prudent-use principles for antimicrobial agents
  • Requests for Product Types
    • Product type 1 – Fixed-dose combination products
      • P1.1 Listing fixed-dose combination 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
      • 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
      • 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 194 Introduction
    • Appendix 6 Including nonhealth outcomes in a supplementary analysis
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Flowcharts and figures

    Page last updated: September 2016

    • Flowchart 1.1 Overview of information requests for Section 1 of a submission to the PBAC
    • Flowchart 2.1 Overview of information requests for Section 2 of a submission to the PBAC
    • Flowchart 2.2 Selection of trials for inclusion in the clinical evaluation
    • Figure 2.5.1 Cumulative distribution function
    • Flowchart 3A.1 Overview of information requests for Section 3A of a submission to the PBAC based on a full cost-effectiveness analysis
    • Flowchart 3B.1 Overview of information requests for Section 3B of a submission to the PBAC based on a cost-minimisation approach
    • Flowchart 4.1 Overview of information requests for Section 4 of a submission to the PBAC
    • Flowchart 5.1 Overview of information requests for Section 5 of a submission to the PBAC
    • Flowchart P4.1 Classification of integrated and streamlined codependent submissions
    • Figure P4.2 Preferred structure of an integrated codependent submission for Section 1
    • Figure P4.3 Preferred structure of an integrated codependent submission for Section 2
    • Figure P4.4 Preferred structure of an integrated codependent submission for Sections 3 and 4
    • Figure A3.1 PRISMA flowchart for presenting initial search results
    • Figure A3.2 Example network diagram of the trials included to inform an indirect comparison of the proposed medicine with the main comparator

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      Submission structure for submissions requiring evaluation

      • Submission executive summary
      • Section 1
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      • Section 3
      • Section 3A
      • Section 3B
      • Section 4
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      Requests for Product Types

      • Product type 1
      • Product type 2
      • Product type 3
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      Appendixes

      • Appendix 1
      • Appendix 2
      • Appendix 3
      • Appendix 4
      • Appendix 5
      • Appendix 6
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