Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme

(including consideration of vaccines for the National Immunisation Program)

Page last updated: 29 October 2020

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.

Content

  1. Purpose
    1.1  Purpose of this document

  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  Cost recovery
    4.5  Pre-submission meetings
    4.6  Integrated codependent submissions

  5. Lodging submissions for listing medicines or vaccines
    5.1  Intent to Apply form
    5.2  Lodging a submission
    5.3  Compliance with standard IT capability
    5.4  Major submissions
    5.5  Minor submissions
    5.6  Committee secretariat submissions
    5.7  New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
    5.8  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  Positive Recommendation 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. Review of PBS listings
    9.1  Drug Utilisation Sub-Committee review
    9.2  Post-market reviews
    9.3  PBAC commissioned reviews of listed medicines

Appendix A - Information sources and contacts

Appendix B - Supporting Guidance for PSDs

Shortened forms and 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