Detsky A S
Departments of Health Administration and Medicine, University of Toronto and the Division of General Internal Medicine and Clinical Epidemiology, The Toronto Hospital, Ontario, Canada.
Pharmacoeconomics. 1993 May;3(5):354-61. doi: 10.2165/00019053-199303050-00003.
In Canada, provincial formulary review committees consider the effectiveness, safety, and cost of products when they derive advice for each Minister of Health. This article offers a draft set of guidelines for pharmaceutical manufacturers making submissions which include economic information, moving beyond a simple presentation of the unit price of the pharmaceutical product (e.g. price per day or course of therapy) and comparison to similar prices for alternative products. A full economic analysis compares all relevant costs and clinical outcomes of the new product with alternate therapeutic strategies for treating patients with a particular condition. The perspective of the decision maker must be clearly identified. The quality of the evidence supporting estimates of the variables incorporated in the analysis should be evaluated. Sensitivity analyses are used to assess the robustness of the qualitative conclusions. Reviewers will examine the answers to a set of 19 questions. Manufacturers can use these questions as a worksheet for preparation of an economic analysis to be incorporated in a submission. These guidelines are intended to be a starting point for further refinement, and discussion with health economists in industry and academia. Considerable flexibility will be used in reviewing documentation supporting economic analysis. Those preparing submissions should be encouraged to experiment with various approaches as part of the general development of this field and to engage provincial review committees in ongoing discussions.
在加拿大，省级药品目录审查委员会在为每位卫生部长提供建议时会考虑产品的有效性、安全性和成本。本文为制药商提交材料提供了一套指导方针草案，其中包括经济信息，不再仅仅简单呈现药品的单价（例如每天的价格或疗程价格），以及与替代产品的类似价格进行比较。全面的经济分析会将新产品的所有相关成本和临床结果与治疗特定病症患者的替代治疗策略进行比较。必须明确确定决策者的视角。应评估支持分析中纳入变量估计的证据质量。敏感性分析用于评估定性结论的稳健性。审查人员将审视对一组19个问题的回答。制造商可以将这些问题用作编制经济分析的工作表，以便纳入提交材料中。这些指导方针旨在作为进一步完善以及与行业和学术界卫生经济学家进行讨论的起点。在审查支持经济分析的文件时将采用相当大的灵活性。应鼓励准备提交材料的人员尝试各种方法，作为该领域总体发展的一部分，并与省级审查委员会进行持续讨论。
