中国大陆与其他国家(地区)药物经济学评价指南的比较研究

Comparative Study on the Pharmacoeconomic Evaluation Guidelines between China's Mainland and Other Countries(or Regions)

目的比较中国大陆药物经济学评价指南与其他国家/地区药物经济学评价指南的一致性和差异性,为中国大陆药物经济学评价指南的发展和完善提供有益参考。方法使用国际药物经济学与结果研究协会(ISPOR)制定的药物经济学评价指南比较框架对中国大陆与其他国家/地区指南的主要内容进行比较,阐述其异同点。结果全球43个国家/地区药物经济学评价指南纳入了比较研究,与其他国家/地区的指南相比,中国大陆指南的大多数条目都与全球国家/地区指南一致,存在差异的几个条目主要是指南的类型/制定主体/使用要求、分析方法以及对预算影响分析的要求。结论建议未来中国大陆药物经济学评价指南的发展和完善可以从丰富指南的制定主体、强化指南执行力度和预算影响分析的运用、加快药物经济学相关基础研究资料的积累和相关概念的宣讲等方面进行。

Objective To provide a useful reference for the development and improvement of the pharmaecomonic evaluation guidelines （PE guidelines） in China's Mainland by comparing to other countries or regions＇ guidelines according to the consistency and difference.Methods The comparative framework of the PE guidelines developed by the International Society of Pharmacoeconomics and Outcomes Research （ISPOR） was used to compare the main contents, especially the similarities and differences between the PE guidelines in China's Mainland and those in other countries or regions.Results Total 43 PE guidelines from the whole world were included and most items of the PE guidelines in China's Mainland are well consistent with other countries and regions, however some differences exist in the guidelines＇ category/constitutor/requirement for use, analysis methods and the requirements for budget impact analysis.Conclusion The pharmacoeconomic evaluation guidelines in China's Mainland could be updated and improved by increasing the types of guideline constitutors, enforcing the implementation of the guidelines and the application of budget impact analysis, speeding up the accumulation of basic research materials and promotion of the concepts related to pharmacoeconomics, etc.