Pharmaceutical Benefits Advisory Committee Guidelines Review
Page last updated: 1 February 2017
The Minister for Health approved a review of the Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (the Guidelines).
The Guidelines are used to prepare submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) so it can assess whether a product should be included on the Pharmaceutical Benefits Scheme (PBS).
The Guidelines help ensure Australians have access to safe, clinically proven and cost-effective medicines as soon as possible, while safeguarding the sustainability of the PBS so it can benefit future generations.
The Guidelines were reviewed to ensure assessment processes are consistent, transparent, and continue to address contemporary methodological issues associated with the PBS.
Scope and Outline of the Review
The Review addressed technical methods issues raised by the PBAC and stakeholders since the last substantial revision.
The Review developed a methods guidance replacing Parts II and III and some of the appendices of the PBAC Guidelines version 4.5.
An external contractor, Adelaide Health Technology Assessment (AHTA), developed the methods guidance with the support of the Guidelines Review Steering Committee. The Guidelines Review Steering Committee consisted of the following representatives from the PBAC, the Economics Sub-Committee (ESC), the Drug Utilisation Sub-Committee (DUSC), industry, other health technology assessment experts and the Australian Government Department of Health to ensure that the Guidelines are of the highest quality and that they continue to reflect best international practice.
- Ms Adriana Platona (Chair) - Departmental Officer
- Ms Julie Cutts (Secretariat) - Departmental Officer
- Professor Andrew Wilson - PBAC Chair
- Professor Rosalie Viney - ESC Chair
- Professor Geoff McColl - DUSC Chair
- Professor Lloyd Sansom - Technical expert
- Professor Jonathan Craig - Technical expert
- Ms Maxine Freeman-Robinson - Technical expert
- Ms Elizabeth de Somer (proxy Dr Greg Cook) - Industry representative
- Dr Michael Coory - Departmental Officer
- Mr Andrew Mitchell - Departmental Officer
- Ms Jan‑Marie Bojadziski/Ms Kellie Gavin - Departmental Officer
Items to be Included in the Review
AHTA was contracted to undertake the Guidelines Review, including the following Items:
- Review of the Guidelines content identifying the methods and current research. Identify significant new developments for methods in relevant sections of parts II and III of the current Guidelines (i.e. since 2008). In undertaking this service the Contractor will consider the relevance to PBAC practice of existing guidance documents on relevant methodologies contained within guidelines published by comparable international health technology assessment agencies, regulators and internationally recognised authorities in the assessment of evidence. The Contractor should note that some early preparation has been undertaken for a new version of the Guidelines and this work must be considered in preparing any revision.
- Preparation of a technical paper for discussion on each issue for the revision, including
identifying any issues of scientific debate and consideration of Australian and International
best practice. Recommendations on editorial and obsolete matters for deletion.
Preparation of proposals for how to address each technical issue for the revision of the Guidelines undertaken by the Contractor for consultation with the Guidelines Review Steering Committee. The current version 4.4 of the Guidelines is a long document and the PBAC is seeking to develop a more concise, clear, focused and up-to-date methods Guidance to replace Parts II and III of version 4.4.
- Consolidation of these into a revised set of Guidelines for methods (with any matters related to process identified and agreed as out-of-scope). Following the Guidelines Review Steering Committee feedback, the Contractor will present the consolidated revised methods Guidelines to the Guidelines Review Steering Committee for review and any additional comment.
- Management of a public consultation process for the proposed revised Guidelines for
The revised methods Guidelines for consultation agreed between the Contractor and the Guidelines Review Steering Committee will be publicly released on the website (pbac.pbs.gov.au) and submissions will be invited. The Contractor will present a summary of the consultation feedback and proposals for further improvements to the Guidelines for consideration and endorsement by the Guidelines Review Steering Committee.
- Incorporate accepted consultation feedback into the draft revised Guidelines.
- Present the finalised revised Guidelines for consideration by the DUSC and the ESC, and for endorsement by the PBAC.
Public Consultation on Items Included in the PBAC Guidelines Review
The public consultation process for the Items Included in the PBAC Guidelines Review closed on 14 September 2015. The public submissions are available at the public consultation page for Items included in the PBAC Guidelines Review.
A number of these submissions included comments about process matters. These process matters were referred to the department for consideration, allowing the Guidelines Review Steering Committee to focus on the methodological issues to be included in the PBAC Guidelines. Many of these process matters have been addressed through the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme.
Policy matters have been referred to the Policy Branch to be addressed as part of ongoing work.
Public Consultation on the draft revised PBAC Guidelines
The public consultation process for the draft revised PBAC Guidelines closed on 5 April 2016. The public submissions are now available at the draft revised PBAC Guidelines public consultation page.
Public Consultation on the draft Assessment of Co-dependent Technology Chapter of the draft revised PBAC Guidelines
The public consultation process for the draft assessment of co-dependent technology chapter of the draft revised PBAC Guidelines closed on 11 April 2016.
The public submissions are now available on the public consultation page for the draft assessment of co‑dependent technology chapter.
Presentation forum on the changes to the structure of the revised PBAC Guidelines
A presentation forum was held on 15 March 2016 to inform interested stakeholders about the revised structure of the PBAC Guidelines including ‘what has changed and what is new’.
AHTA provided an overview of the structural changes as well as details about changes to the clinical and economic components.
Members of the Guidelines Review Steering Committee, along with the AHTA, responded to questions from interested stakeholders.
Focus Group Meeting - the comparator subsection
A focus group meeting was held on 15 August 2016 with key industry representatives, the Chair of the PBAC, and senior departmental officers to discuss the comparator subsection of the guidelines.
Drug Utilisation Subcommittee and Economics Subcommittee
Presentations and regular updates were provided at each meeting of the DUSC and ESC throughout the review. The DUSC and ESC commented on the draft PBAC Guidelines in February 2016 and commented on the final draft document in August 2016.
Endorsement of the PBAC Guidelines
On 19 September 2016, the PBAC endorsed version 5.0 of their guidelines.
Whilst submissions to the PBAC will now need to follow the guidance provided in the PBAC Guidelines version 5.0, the PBAC 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.
Education workshops were arranged to assist industry organisations who will be making a PBAC submission using version 5.0 and for evaluators who prepare commentaries on major submissions to the PBAC. The workshops sought to promote a common understanding and interpretation of the guidance within the PBAC Guidelines.
Workshops for industry organisations
The workshops for industry organisations were presented by Adelaide Health Technology Assessment and facilitated by ARCS Australia.
A total of five workshops were held - three in Sydney (14, 19 and 20 October 2016) and two in Melbourne (17 and 24 October).
- provided an overview of the structural and content changes between version 4.5 and version 5.0 of the PBAC Guidelines
- discussed key areas of the guidelines and provided worked examples
- advised on where to put relevant information when preparing a submission
- discussed approaches that can be taken when presenting the information
- discussed submissions for codependent technologies
- explained the structure and use of the Section 4 workbook.
Workshops for evaluators
An education workshop has been arranged for evaluators of PBAC submissions to:
- provide an overview of the structural and content changes between version 4.5 and version 5.0 of the PBAC Guidelines
- discuss key areas of the guidelines and provide worked examples
- advise on how to assess relevant information when evaluating a submission
- discuss evaluations for codependent technologies
- discuss the preparation of commentaries.
The current PBAC Guidelines are available through the PBS website.
Information on the Post-Market Reviews Framework is also available on the PBS website.
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