质量与疗效一致性评价视角下的仿制药替代费用节省、临床效果与处方行为机制研究

From the perspective of the quality and efficacy of the generic drug and the promotion for the supply and use of generic drugs national policies, generic substitution is our inevitable choice to meet the major needs of people's livelihood and to promote supply-side structural reform of generic pharmaceutical industry in our country. Based on previous research, we found that empirical research on the economic benefits, basic assumptions and incentive mechanisms of generic drug substitution policies in China is limited. Therefore, the project will carry out the following studies: (1) to measure the generic drug substitution rate and the potential maximum cost savings; (2) to compare the effectiveness between generic drugs and original drugs through the real world data; (3) to explore the doctor's prescribing behavior mechanism controlling factors of behavior preferences and state dependence. Based on the Urban Employee Basic Medical Insurance (UEBMI) and Urban Rural Basic Medical Insurance (URBMI) database in Shananxi Province, this study will calculate the potential maximum cost savings of generic substitution from patient out-of-pocket, medical insurance and medical provider perspectives, respectively. The comparative effectiveness research was used to compare the clinical equivalence between generic drugs and original drugs. Finally, we try to link the doctor Knowledge-Attitude-Practice (KAP) research data with the medical insurance database to control the preference of doctors prescribing behavior and the state dependence, and intent to use dynamic panel model to explore the doctor prescription behavior mechanism. Address the above issues will be helpful to establish generic substitution mechanism and push forward the process of promotion for the supply and use of generic drugs national policies in China.

在仿制药质量和疗效一致性评价工作与促进仿制药供应保障与使用的国家政策背景下，实现仿制药替代是满足民生重大需求，促进仿制药产业供给侧结构改革的重大科学和现实问题。基于前期研究发现，我国对于仿制药替代政策的经济效益、基础假设与激励机制的实证研究还比较匮乏。为此，本课题进行以下深入研究：（1）仿制药替代率与潜在最大费用节省的测量；（2）真实世界仿制药与原研药比较效果研究；（3）控制行为偏好与现状依赖的医生处方行为机制研究。基于陕西省城镇职工/城乡居民基本医疗保险数据库，将从患者、医疗保险与医疗机构三个角度分别测算仿制药替代的潜在最大费用节省。采用真实世界比较效果研究方法对比仿制药与原研药的临床等效性。将医生KAP调研数据与医疗保险数据库进行链接，控制处方行为偏好与现状依赖，采用动态面板模型探索医生处方行为机制。破解以上基础性科学问题将为我国仿制药替代政策及其激励机制的出台提供有力循证支持。

本项目从经济、临床与人文的视角探究仿制药替代的经济效果、临床等效性与医生处方行为机制。有如下发现：（1）少数药品（“4+7带量采购的25中药品”）的仿制药替代即可达到大量的费用节省；不同地区节省费用差异较大；（2）通过meta分析的研究结果显示，抗癫痫药的疗效与安全性在仿制药与原研药中的差异并不显著；（3）在我国仿制药替代政策实施的初期，不到1/3的医生对于仿制药的知识良好，不到一半的大夫倾向于仿制药替代。如果医生对于仿制药的临床效果、替代政策更为了解以及加以经济激励，医生进行仿制药替代的积极性会更高；真实世界数据结果显示对于城镇职工医疗保险的参保人而言，尤其是省医保中大多数的干部人群，一方面，医生与患者均没有仿制药替代的意愿；另外，由于报销政策导致其对于价格的敏感性消失，无论是慢性病还是肿瘤患者，这部分人群更倾向于开处原研药。此外，从促进仿制药供应保障的角度，课题负责人开展了药品价格放开政策对于低价药的供应的影响研究。针对仿制药与原研药的价格敏感性，开展了药品价格弹性研究。依托本项目，课题主持人以第一作者在JCR1区《Frontiers in Pharmacology》发表论文2篇，《International Journal of Environmental Research and Public Health》和《中国药业》发表相关论文，积极促进我国仿制药替代政策的实施与推进。

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