6.1 PBAC subcommittees

Page last updated: October 2016

Under the Act, the PBAC may also establish subcommittees to help it perform its functions. There are currently two subcommittees – ESC and DUSC.

6.1.1   Composition of PBAC and its subcommittees

The PBAC membership is prescribed in the National Health Act 1953. The members provided for in the Act are appointed by the Minister for Health, and include medical practitioners (specialists, general practitioners and clinical pharmacologists), pharmacists, consumers, health economists and industry representatives. The membership is published in the Government Gazette and details are available on the PBS website.

The Minister for Health appoints the PBAC Chair and the Deputy Chair.

The membership of DUSC includes clinicians, pharmacists, pharmacoepidemiologists, industry representatives and consumers who have a broad range of relevant expertise in the evaluation of medicine use. The membership of DUSC is published on the PBS website.

The membership of ESC includes clinicians, clinical epidemiologists, health economists, biostatisticians and clinical pharmacologists who have a broad range of relevant expertise in clinical epidemiology and health economics. The membership of ESC is published on the PBS website.

6.1.2   Role of the Economics Sub-Committee

ESC reviews and interprets economic analyses submitted by the sponsor and the evaluations performed by evaluation entities on submissions to list medicines on the PBS. ESC advises the PBAC on the quality, validity and relevance of these submissions. ESC is also responsible for advising the PBAC on methodological developments on the collection, analysis and interpretation of clinical and economic data.

The subcommittee also provides advice on the content of the Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee.

Selection of submissions and reports for consideration

ESC considers all major submissions to the PBAC. ESC reviews the information provided in the submission and considers the commentary prepared by the evaluation group (refer to Section 6.2.2) and the TGA documents provided. ESC identifies important uncertainties and key issues for the PBAC about listing the medicine on the PBS or the vaccine on the NIP.

ESC also reviews reports on currently listed medicines where there are potential issues of comparative clinical effectiveness and cost-effectiveness.

How ESC provides advice to the PBAC

ESC advises the PBAC as a document called the ESC Advice. This is also provided to the sponsor. An ESC Advice is prepared for each major submission and report considered by ESC.

6.1.3   Role of the Drug Utilisation Sub-Committee

DUSC monitors the patterns and trends of medicine use, and makes such data publicly available. DUSC evaluates use and financial forecasts of selected major submissions to the PBAC.

DUSC considers a selection of submissions to the PBAC. DUSC advises the PBAC and the sponsor on important matters relating to use and cost, and reviews utilisation of currently listed PBS medicines.

Selection of submissions and reports for consideration

DUSC does not consider submissions where the estimated use and cost of the medicine, or a medicine of the same class, for the indication has already been reviewed, or where previous DUSC advice has been incorporated into the submission. DUSC does not consider submissions only relating to pricing matters, or where the utilisation and cost issues are unlikely to be substantially altered by the addition of the new medicine to the PBS. Examples of the latter include where there is a small clearly defined patient group, or the market is stable or where the medicine is for a non-PBS program.

DUSC reviews the PBS listing for medicines that have been listed for an initial period of 24 months. The subcommittee selects individual medicines or groups of medicines to be reviewed (refer to Section 9.1). The sponsor is informed of the review after the meeting at which the selection of the medicine for review is made. Planned reviews are also listed in the outcomes of the DUSC meeting, which are published on the PBS website.

How DUSC provides advice to the PBAC

DUSC advises and reports about selected submissions to PBAC as a document called the DUSC Advice. The DUSC Advice is also provided to the sponsor.

 

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