国外促进仿制药使用政策实施效果研究

Analysis on the implementation effect of policies on promoting the use of generic drugs in foreign countries

目的:系统评估国外促进仿制药使用政策的实施效果,为我国制定和完善仿制药相关政策提供参考。方法:在PubMed数据库检索促仿制药使用政策执行效果的相关实证研究,检索时限为建库至2021年2月22日。按照拟定纳排标准进行文献筛选,对符合标准的文献进行系统综述。结果:促进仿制药使用政策能有效控制仿制药费用、降低药品价格、增加仿制药处方量、增加仿制药市场份额、减少患者因费用导致的不依从以及改善健康相关生命质量。但有研究表示扩大共付额差值可能会增加患者的自付费用、限制患者的药品用量或使患者的依从性降低。结论:促仿制药使用政策实施后,总体药费支出降低、仿制药的利用得到了改善,但患者个体水平上的获益仍有待进一步研究。

Objective: To systematically review the implementation effect of policies on promoting the use of generic drugs, and provide evidence for the subsequent formulation and improvement of relevant policies in China. Methods: PubMed was searched for relevant empirical studies on the implementation effect of policies on promoting the use of generic drugs. Studies published from database establishment until February 22, 2021 were included. The studies were screened according to the inclusion and exclusion criteria, and the eligible studies were systematically reviewed. Results: Generic drug policy can effectively control the cost of generic drugs, reduce drug prices, increase the amount of generic drug prescriptions, increase the market share of generic drugs, reduce patients’ non-compliance due to cost, and improve health-related quality of life. Nevertheless, certain studies have shown that cost-sharing may increase out-of-pocket cost and limit drug usage or reduce patient compliance. Conclusions: The implementation of policies on promoting the use of generic drugs has made progress in reducing the overall drug expenditure and improving the utilization of generic drugs. However, the benefits at individual patient level remain to be further studied.