Not all submissions to the Drug Programs Branch require a cost-effectiveness analysis, but the submitting manufacturer must either include one or justify its absence. Although the following guidelines provide a means for identifying and formatting the basic information necessary for a effectiveness analysis, and provide some guidance on an appropriate form of cost-effectiveness analysis in a particular instance, it is recognized that these suggestions will not always be appropriate for all clinical circumstances and products. Departures from it are therefore acceptable, if accompanied by a justification. In some cases, a full cost-effectiveness analysis will be impossible because the instrument for measuring various aspects of the analysis is not available (e.g., utility measurements for mental health). When drugs are equally effective and have a similar sideeffect profile, a comparison of total costs of therapy alone may be appropriate.

The DQTC will evaluate the need for a detailed analysis based on its estimation of the need for, and the feasibility of, such an analysis, and the overall impact of the new product on aggregate expenditures.

The questions asked in Table I constitute a checklist of questions or information requirements against which cost-effectiveness analyses included in submissions will be evaluated. They are guidelines for those preparing Formulary submissions in that they tell manufacturers what questions will be asked by the DQTC. Manufacturers can use this checklist to evaluate the evidence of cost-effectiveness presented in their submission. The submission should take the form of providing a document that describes the cost-effectiveness analysis and then listing the questions in Table 1 and providing answers to each question. Background documents including unpublished and published article(s) reporting the cost-effectiveness analysis should be provided, with the sections of the article(s) marked that directly address the information requirements identified in each question of the guidelines. A clear, concise answer to each question, with appropriate documentation that is clearly marked, will greatly facilitate review of the cost-effectiveness document. See also "Summary and suggested format" for more information on the format.

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