The November 1995 revised Australian guidelines for the economic evaluation of pharmaceuticals.

In November 1995, the revised Australian Guidelines for the Economic Evaluation of Pharmaceuticals ('the Guidelines') were published. The new document is to be seen as a measured bureaucratic response to the perceived shortcomings of the August 1992 document. The new document sets substantially more demanding and more rigorous evidentiary standards in the reporting of randomised clinical trials and in the justification of the selected evaluation methodology. It also introduces the requirement for a trial- or efficacy-based preliminary economic evaluation, and it recognises the need, under certain circumstances, to model economic evaluations. Although this document has an immediate appeal to those coming to pharmacoeconomic evaluations from a clinical perspective, the approach taken is unlikely to appeal either to economists (the Guidelines continue to discourage cost-benefit analysis) or to health system evaluators working in a competitive delivery environment (such as the US). The Guidelines, in a US environment, would be seen as not only unreasonable in their evidentiary demands and in the task imposed on evaluators, but limited in their failure to take an explicit modeling or system approach to therapy intervention evaluations.