Making a case for inclusion of new oral anti-diabetic agents in drug formularies

Diabetes mellitus represents a major burden upon healthcare resources with around 13% of the direct costs attributable to drug treatments. Therefore a justifiable approach to the selection of cost-effective drugs is a vital part of the management process. As the number of oral anti-diabetic agents increases, it would be useful to have a structured process or model to assess each new agent for addition to a local drug formulary and to define its place in the local management strategy. Since the introduction of unified budgets in April 1999, it is important that this process enables collaboration between clinicians in a primary and secondary care in order to encourage joint decisions on products prescribed in both sectors. In this article a model is presented, which could assist a clinical team to produce and present a substantive case for a new product to their Drug and Therapeutics or Local Area Prescribing Committee. The model proposed offers a template with which to make rigorous, justifiable and consistent assessments of anti-diabetic drugs for inclusion in a local formulary. The model is discussed in the context of oral anti-diabetic agents for type 2 diabetes in the UK, however, users may customise it to accommodate local requirements and circumstances. In principle this model could also be adapted for use with any group of drugs to treat a chronic metabolic disorder. Copyright (C) 2000 John Wiley and Sons, Ltd.