THE ROLE OF PHARMACOECONOMIC GUIDELINES FOR FORMULARY APPROVAL - THE AUSTRALIAN EXPERIENCE

This paper provides a review and critique of the recently introduced A ustralian Guidelines for the Presentation of Submissions to the Pharma ceutical Benefits Advisory Committee (Guidelines), which require pharm aceutical companies seeking recommendation for national formulary list ing and subsidization to provide a detailed economic analysis to suppo rt their case. As Australia is the first country to mandate such a req uirement, it is important not only to consider the details of the Guid eline's requirements for economic analysis and the expectations of the authors, but also to consider, from both theoretical and practical pe rspectives, whether the Guidelines are appropriate for drug evaluation purposes. Although the Guidelines have raised the level of awareness of the need to integrate economic analysis into the formulary approval process, their contribution as a model for other jurisdictions must b e qualified by the prescriptive and unduly narrow view that is taken o f allowable analytical techniques. By forcing drug evaluations into a straightjacket, the Guidelines run the risk of undermining the credibi lity and contribution of economic analysis to formulary decisions.