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目的:为我国医保预算影响分析(BIA)研究指南的制定及实施提出相关建议。方法:检索国际药物经济学与结果研究协会(ISPOR)以及加拿大、美国等国的医保BIA指南或相关文件,对比其异同点,总结其在医保BIA分析框架、数据来源、报告格式等方面的做法及对我国的启示。结果与结论:ISPOR、加拿大、美国等制定的医保BIA指南或相关文件在以医保基金运营方为研究视角、基于自然因素和流行病学数据计算目标人群、以3~5年为研究时限等要素的规范性要求上具有一致性,但有关药品加价、配送费等额外成本的核算各指南或相关文件均认为应根据各国或地区卫生体制的独有特征进行具体调整。我国在立足自身卫生体制实际情况的基础上,可制定包含模型设计、研究视角、适应人群、当前干预措施的使用现状及新干预措施引入对市场影响的预估、当前及新干预措施的成本、时间范围、贴现、不确定性分析及情景分析、验证等要素的医保BIA指南,更好地发挥其在医保目录制定、调整和药品价格谈判中的作用。
OBJECTIVE: To put forward relevant suggestions for formulating and implementing medical insurance budget impact analysis (BIA) research guideline in China. METHODS: The medical insurance BIA guidelines or relevant documents were retrieved from ISPOR, Canada and the United States. Their similarities and differences were compared. The experiences of them were summarized in respects of research framework, data source and report format of medical insurance BIA. RESULTS & CONCLUSIONS: ISPOR, Canada, USA and other guidelines or relevant documents have some similarities in normalization requirements of research perspectives, target population calculation based on natural reason and epidemiological data, 3-5 years as the research time limit and some other respects. But the calculation of additional costs as drug price addition, distribution fee should be specifically adjusted according to the unique characteristics of the health systems of countries or regions. Based on the actual conditions of our own health care system, our country can draw up the guidelines for medical insurance BIA impact analysis, which contain model design, research perspective, target population, current use of intervention measures, prediction on the effects of new intervention measure introduction on the market, cost, time range, discount and uncertainty analysis of current and new interventions, situational analysis and verification, so as to better play its role in the formulation and adjustment of medical insurance catalogues and in drug price negotiations.
医保预算影响分析指南药物经济学医疗保险
Budget impact analysisguidelinePharmacoeconomicsMedical insurance
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