Australia has a well-developed system for the appraisal of pharmaceuticals and other health technologies. In January 1993, Australia was the world leader with mandatory economic evaluations for the government to consider subsidising pharmaceuticals on the Pharmaceutical Benefits Scheme. At the end of 2006, the Guidelines to sponsors underwent substantial revisions. In addition, other fundamental changes have recently occurred that present new challenges to the Pharmaceutical Benefits Advisory Committee (PBAC); these include the requirement for greater transparency of the PBAC process and appraisals following the Australia-United States Free Trade Agreement, and the appraisal of vaccines by the PBAC. This editorial describes some recent developments and their key features in the appraisal of pharmaceuticals in Australia. The PBAC standards and technical requirements seem to have lost ground on the world stage. For example, the lack of a reference case and absence of probabilistic sensitivity alysis requirements have hindered the ability to make judgements on the relative value for money of new pharmaceuticals. Thus, the guidelines do not go far enough to advance standards for best practice. A better approach may have been to specify an objective list of criteria for judging the quality of submissions. Nevertheless, this latest (2006) revision to the PBAC guidelines is a highly useful and comprehensive guide on health technology assessment.
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