Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme

(including consideration of vaccines for the National Immunisation Program)

Page last updated: 21 December 2022

Information within the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme supersedes all other procedural information on the same topic that may be located elsewhere on the PBS website.

• Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme v2.5 (PDF 1MB) - (Word 280KB)

Content

1. Purpose
   1.1  Purpose of this document
   1.2 Cost recovery

2. Listing process

3. Confidentiality and transparency
   3.1  Managing and assessing confidential material
   3.2  Managing conflicts of interest
   3.3  Managing outcomes processes transparently

4. Pre-submission requirements
   4.1  Types of submissions
   4.2  Guidelines for preparing submissions
   4.3  Timeframes for the PBS
   4.4  Pre-submission meetings
   4.5  Integrated codependent submissions

5. Lodging submissions for listing medicines or vaccines
   5.1  Intent to Apply
   5.2  Lodging a submission
   5.3  Compliance with standard IT capability
   5.4 Category 1 and Category 2 submissions
   5.5 Category 3 and Category 4 submissions
   5.6  Committee secretariat submissions
   5.7  Reconsideration of a Recommendation
   5.8  New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
   5.9 Providing documents after lodging a submission

6. Procedures for consideration of submissions
   6.1  PBAC subcommittees
   6.2  Evaluation of submissions
   6.3  Management of parallel process submissions
   6.4  Input of the applicant into the PBAC consideration
   6.5  Role of the Australian Technical Advisory Group on Immunisation for requests to list vaccines
   6.6  Role of the Nutritional Products Working Party
   6.7  Consumer input
   6.8  Additional clinical input
   6.9  PBAC and subcommittee members attending other meetings
   6.10 Stakeholder meetings
   6.11 Codependent submission processes

7. Post-PBAC procedures for applicants
   7.1  Notification of outcomes of PBAC
   7.2  Independent review
   7.3  PBAC Outcomes
   7.4  Public Summary Documents

8. Procedures for a positive recommendation to list
   8.1  Pricing pathways
   8.2  Notice of Intent for Pricing
   8.3  Pricing offer package
   8.4  Negotiation and agreement
   8.5  Finalisation of the budget impact
   8.6  Finalisation of Restriction wording
   8.7  Preparation and finalisation of additional access arrangements
   8.8  Other listing documents required
   8.9  Notification of listing on the PBS
   8.10  Listing a vaccine on the NIP

9. Procedures for submissions not recommended
   9.1 Resubmission pathways
   9.2 Intent to Apply – resubmission pathways
   9.3 Lodging a submission for a resubmission pathway
   9.4 Facilitated Resolution Workshop
   9.5 Resubmission requirements and procedures for consideration of resubmissions
   9.6 Post-PBAC procedures for applicants

10. Review of PBS listings
    10.1 Drug Utilisation Sub-Committee review
    10.2 Post-market Reviews
    10.3 PBAC requested research report

Appendix A - Information sources and contacts

Appendix B - Supporting Guidance for PSDs

Shortened forms and definitions

• Acronyms and abbreviations
• Definitions

 

Record of updates

Record of updates

Date	Version	Summary of changes
October 2016	Version 1.0	Procedure guidance released.
September 2017	Version 1.1	Updated parallel process guidance at 6.3 and Department of Health Branch and Division names
January 2018	Version 1.2	Updated Procedures for consideration of submissions at 6.6 Role of the Nutritional Products Working Party
September 2018	Version 1.3	Updated parallel processing of a biosimilar medicine at 6.3 Management of parallel process submissions.
February 2019	Version 1.4	Updated documentation requirements at 5.7 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration). Updated contact information at A.2.6 Matters relating to confirming the price and other post-PBAC recommendation matters.
June 2019	Version 1.5	Updated documentation requirements at 5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration). Updated contact information at A.2.6 Matters relating to confirming the price and other post-PBAC recommendation matters
October 2019	Version 1.6	Updated procedures at:  2. Listing process, 4.4 Cost Recovery, 4.5 Pre-submission meetings, 8. Procedures for a positive recommendation to list. Updated document to include 5.1 Intent to Apply form. Updated contact information at A.2.2 Matters related to pre-submission meetings and post-PBAC meetings with the Chair.
April 2020	Version 1.7	Updated procedures at: 7.4 Public Summary Documents
June 2020	Version 1.8	Added Definitions, updated references to ‘days’ and timelines and other minor updates for clarification across the document. Updated procedures at: 2. Listing process, 3.1.1 Material contained in submissions, 4.3.2 Timeframes for integrated codependent submissions, 5. Lodging submissions for listing medicines or vaccines including 5.1 Intent to Apply form, 6.5 Role of the Australian Technical Advisory Group on Immunisation for requests to list vaccines, 7.4 Public Summary Documents. Updated document to include 3.3.6 Medicine Status Website and Appendix B.
July 2020	Version 1.9	Updated procedures at: 7.4 Public Summary Documents
November 2020	Version 1.10	Updated procedures at: 5.7 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
December 2020	Version 2.0	Added definition and updated Section 1. Purpose. Updated procedures to reflect the introduction of Stage 2 PBS process improvements including revised submission categories and new resubmission pathways includes changes to processes at 2. Listing process, 3. Confidentiality and transparency, 4. Pre-submission requirements, 5. Lodging submissions for listing medicines or vaccines, 6. Procedures for consideration of submissions, 7. Post-PBAC procedures for applicants, 8. Procedures for a positive recommendation to list and the addition of a new ‘Section 9 – Procedures for submissions not recommended’. Updated contact details at Appendix A.2
September 2021	Version 2.1	Updated requirements under Criterion 2 at: 7.4 Public Summary Documents and Appendix B
October 2021	Version 2.2	Updated Section 5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration) to provide guidance for applications to list new brands on the Repatriation Pharmaceutical Benefits Scheme.
December 2021	Version 2.3	Updated Section 8.9 Notification of listing on the PBS
April 2022	Version 2.4	Updated procedures at: 4.1.3 Category 3 submissions, 4.1.4 Category 4 submissions, 4.1.6 Application for a new brand or new oral form of an existing pharmaceutical item, 5.5 Category 3 and Category 4 submissions, 5.8 New brand or new oral form of existing pharmaceutical item submissions (not requiring PBAC consideration), 6.3 Management of parallel process submissions, and 9.1 Resubmission Pathways.  References to remade National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022 updated throughout the procedure guidance.
November 2022	Version 2.5	Updated procedures at: 7.4.3 Timeframe for Public Summary Document publication, to ensure consistency with Section 6.3. Updating the Department’s name to the Department of Health and Aged Care.