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 * Version 5.0
 * About the Guidelines
 * Table of Contents

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 * Home
 * 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
 * Contacts


GUIDELINES FOR PREPARING SUBMISSIONS TO THE PHARMACEUTICAL BENEFITS ADVISORY
COMMITTEE (PBAC)


VERSION 5.0


SEPTEMBER 2016

The PBAC Guidelines explain in detail how to prepare a submission to list a new
medicine or medicinal product on the Pharmaceutical Benefits Schedule (ie for
public funding). The guidelines provide detailed instructions on what
information is required by the PBAC and the Economic Sub-Committee (ESC) to
support a proposed new medicine, and the most appropriate form of clinical
evidence and economic evaluation for specific submissions.

Whilst submissions to the PBAC will now need to follow the guidance provided in
the PBAC Guidelines version 5.0, the PBAC has approved a transitional
arrangement of two PBAC cycles in regard to the structure of submissions. That
is, submissions to the PBAC for consideration at either the March or July 2017
PBAC meetings may follow the structure of either version 4.5 or version 5.0 of
the Guidelines. Submissions for consideration at the November 2017 meeting must
follow the structure of version 5.0 of the PBAC Guidelines.

For information on processes, procedures, timelines and documents required,
refer to the Procedure guidance for listing medicines on the Pharmaceutical
Benefits Scheme.


SUBMISSION STRUCTURE FOR SUBMISSIONS REQUIRING EVALUATION




PBAC HELP CENTRE FOR MAKING A SUBMISSION


DOWNLOADS

Printable version of PBAC guidelines

Checklists, Templates & Workbooks

Utilisation and cost model workbook

Forms


INFORMATION

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

Appendix 6 Including nonhealth outcomes in a supplementary analysis


CONTACT

Enquiries about PBAC submissions can be mailed or emailed to the Pharmaceutical
Evaluation Branch at the following address:

Pharmaceutical Evaluation Branch
MDP 910
Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
Email: PBAC@health.gov.au

 


DEPARTMENT OF HEALTH AND AGED CARE

Department of Health and Ageing


PBAC GUIDELINES

© Commonwealth of Australia
ABN: 83 605 426 759


USEFUL LINKS

 * Glossary of terms
 * PBAC Manual
 * PBAC Meetings
 * Listing Unit Requirements
 * PBS Calendar
 * PBS.gov.au Website


PBAC INFORMATION

 * Abbreviations and acronyms
 * Flowcharts and figures
 * Document table
 * Tables


SUBMISSION STRUCTURE FOR SUBMISSIONS REQUIRING EVALUATION

 * Submission executive summary
 * Section 1
 * Section 2
 * Section 3
 * Section 3A
 * Section 3B
 * Section 4
 * Section 5


REQUESTS FOR PRODUCT TYPES

 * Product type 1
 * Product type 2
 * Product type 3
 * Product type 4


APPENDIXES

 * Appendix 1
 * Appendix 2
 * Appendix 3
 * Appendix 4
 * Appendix 5
 * Appendix 6
 * Printable versions
 * Contacts
 * Forms