PBS Process Improvements

Page last updated: 17 July 2019

The Department of Health and Medicines Australia have been working since late 2017 to deliver on commitments to streamline medicines listing processes and revise cost recovery arrangements as set out under clause 10 of the Strategic Agreement.

Changes Commencing from 1 July 2019

  • Changes to pre-submission meetings to provide additional guidance and support for complex submissions.
  • Introduction of a compulsory intent to apply step for Major and Minor submissions.
  • Introduction of four new transparent pathways following a positive PBAC recommendation

Updated Procedure Guidance

New PBS Forms to support the process changes:

Pre-submission

  1. Application Form for Pre-submission Services  (Pre-submission Meeting Request form) (Word 84KB)
  2. Pre-submission Briefing Paper (Word 94KB)
  3. Pre-submission Meeting Outcomes template  (Word 76KB)

Submission

  1. Application Form for Submission Services (Word 114KB):
  • PART A – Intent to Apply
  • PART B – Application to accompany PBAC Submission
  • PART C – Application for New Brand of existing pharmaceutical item

Pricing & Listing

  1. Application Form for Pricing Services (Word 102KB):
  • PART A – Notice of Intent for Pricing
  • PART B – Pricing Application

List Management

  1. Application Form for List Management Services (Word 84KB), to be used for:
  • Ministerial Discretion not to apply a Statutory Price Reduction request
  • Price increase requests
  • Brand Premium requests
  • New item recognised as a new presentation request.

The Cost Recovery Implementation Statement and Cost Recovery Administration Guidelines are available on the Cost Recovery web page.

Transition Arrangements summary table

Commencement Date

Activity

1 July 2019

Revised cost recovery arrangements apply for all requests for services.

PRE-SUBMISSION

3 July 2019

First opportunity for lodgement of a Pre-submission Meeting Request Form.

5 August 2019

First Pre-submission meetings available.

INTENT TO APPLY

26 July 2019

Intent to Apply deadline for Minor submissions to be considered at the November 2019 PBAC meeting.

9 October 2019

Intent to Apply deadline for Major submissions to be considered at the March 2020 PBAC meeting.

22 November 2019

Intent to Apply deadline for Minor submissions to be considered at the March 2020 PBAC meeting.

POSITIVE RECOMMENDATION PATHWAYS

9 August 2019

First opportunity for lodgement of Notice of Intent for Pricing form (and case managers assigned for Pathway A) – minimum 7 days after ratified Minutes for positive recommendations are issued.

16 August 2019

First opportunity for lodgement of pricing offer packages (minimum 7 days after lodgement of Notice of Intent for Pricing).

Background

In April 2017, the Government made a commitment to streamline PBS listing processes under clause 10.3 of the Strategic Agreement with Medicines Australia. The aim of this commitment is to improve the efficiency, transparency and timeliness of the PBS listing process over the five year term of the agreement. 

The department and industry, through the Access to Medicines Working Group – Streamlined Pathways Subgroup collaborated with key stakeholders to develop the revised pathways framework for the Minister’s approval by July 2018.

In August 2018, the Minister for Health approved broad consultation on the revised pathways framework and endorsed a staged implementation approach. Two consultation forums with consumers, clinicians and industry occurred in September 2018.

Further public consultations were held in March, April and June to inform the Stage 1 PBS Process Improvements, which will be implemented incrementally from July 2019.

Resources

Contact Us

If you have any questions regarding the PBS Process Improvements, please contact the implementation team via email (PBSimprovements@health.gov.au).

Information regarding future consultations will be sent via PBS News notifications, if you would like to receive email notification from PBS News and updated publications you can subscribe via the PBS website.