Industry comment on the 1995 revised Australian pharmacoeconomic guidelines.

Abstract

This article is a critique of the 1995 revised Australian guidelines (the revised guidelines)lll for the pharmaceutical industry on preparation of submissions to the Phannaceutical Benefits Advisory Committee (PBAC). PBAC is the body responsible in Australia for recommending the approval of drugs for reimbursement on the Phannaceutical Benefits Scheme (PBS). The guidelines were first released to the pharmaceutical industry in Australia in August 1990, were revised in August 1992 and became mandatory in January 1993. The intention for the current revision of the guidelines was signalled in the preface to the 1992 guidelines,l21 The opinions expressed in this article are an interpretation of the collective opinion of the Health Economics Subcommittee of the Australian Pharmaceutical Manufacturers Association (APMA), of which the authors are members. The revised guidelines appear to primarily reflect a clinical preference in evaluation methodology. They fail to encourage the application of true economic theory to the evaluation of pharmaceuticals, and will therefore fail to foster the growth of sound health economic analysis. There has been a shift from encouraging the use of estimated final health outcomes in the former guidelines to specifying the selection of outcomes on scientific rather than economic criteria in the 1995 revised guidelines. This approach values the certainty of a measured outcome in a controlled experimental environment more highly than the relevance of the outcome in the estimation of actual benefit of a product in community use. Thus, the revised guidelines focus on the assessment and grading of the quality of the presented data, with little regard to the contribution these data will make in the final assessment of the true economic and clinical value of the product.