Funding new cancer drugs in Ontario: Closing the loop in the practice guidelines development cycle

Purpose: The previously described practice guidelines development cycle fol lows an iterative model in which recommendations are reached by a process t hat incorporates practitioners at all phases. A key feature is the separati on of the evidence-based systematic review and the generation of recommenda tions from policy decisions surrounding implementation. This article descri bes how this implementation phase has evolved in Ontario and how implementa tion has affected the guidelines process. Methods: The development of the New Drug,Funding program in Ontario and the appointment of a policy advisory committee (PAC) to make funding recommend ations were reviewed. The decision-making framework of the PAC is described in this article. Results: The PAC hers herd to address a number of issues in making funding recommendations, These issues have included dealing with evidence arising s olely from phase II versus phase III trials, using economic information, an d involving community representatives in its deliberations. Its activities have had a substantial impact on the practice guidelines initiative. Conclusion: It is possible to integrate an evidence-based, practitioner-dri ven approach to clinical guideline development with ct funding program that takes policy considerations into account. However, even though these two r oles are conceptually separate, the needs of the funding program have inevi tably had an impact on the guidelines process. (C) 2001 by American Society of Clinical Oncology.