目的 分析中国药物经济学评价指南的应用现状和主要挑战。方法 梳理中国卫生政策对药物经济学的需求,分析中国药物经济学研究和指南应用现状,对国际上主要国家或地区药物经济学指南的应用和发展情况进行汇总。结果 在中国医药卫生决策方面,药物经济学评价及其证据在新药研发、药品定价、医保支付及临床合理用药方面将发挥重要作用。由于《中国药物经济学评价指南》是专家建议指南,而非政府强制使用,加之中国缺乏开展高质量药物经济学研究的临床和流行病学基础数据,使得其在实际应用中遇到了诸多困难和挑战,远未发挥其应有的作用。结论 基于国际经验和中国实际,建议国家强制或鼓励药物经济学评价指南在医疗卫生和医保决策中发挥作用;建议成立药物经济学评价的国家认证机构;建议定期更新和补充指南内容;同时加强临床、合理用药、药物流行病、生命质量等基础性研究。
Abstract
OBJECTIVE Analyze the applications and challenges of guidelines for pharmacoeconomic evaluation (PE) in China. METHODS Reviewing what Chinese health policy need from pharmacoeconomics; analyzethe applications and challenges of guidelines for PE in China; summarize the application and development of the guidelines for PE in the world. RESULTS PE plays an important role in Drug development, pricing, reimbursement and evidenc-based clinical pathway. Since PE guidelineis not mandatory in healthcare policy decision making in China, and there are lack of high-quality, reliable database for PE, the guideline encountered many difficulties and challenges in practice and hasn′t play its due role yet. CONCLUSION Based on the experience from other counties and practical in China, we recommended that PEguideline shouldbe mandatory. It is recommended to set up national research institutions for PE, and update or supplementthe guidelines regularly. Moreover, the basic research should be strengthened, such as rational drug use, pharmacoepidemiology, quality of life.
关键词
药物经济学 /
中国药物经济学评价指南 /
药物经济学评价
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Key words
pharmacoeconomics /
China guidelines for pharmacoeconomic evaluation /
pharmacoeconomic evaluation
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中图分类号：
R956
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