中成药医保准入的影响因素分析

Analysis of influencing factors on the inclusion of Chinese patent medicines in the national reimbursement drug list

目的分析影响中成药在国家医保目录准入的因素,助力中成药在医保准入中充分体现实际价值。方法从国家医保局官网获取2021-2023年通过形式审查的目录外中成药的申报材料,包括药品的基本信息、安全性、有效性、创新与传承信息,并参考药典和药智网等进行补充;经济性信息和企业信息通过药智网等网站获取。对药品的首次申报信息和准入结果进行单因素分析、多因素Logistic回归分析和逐步回归分析;并将在不同年份进行多次申报的药品均作为独立样本进行敏感性分析。结果与结论2021-2023年通过形式审查的目录外中成药有27个,涉及37次申报。单因素分析结果显示,药品说明书中适应证/功能主治描述中含有中医证型、有明确的特殊人群用药方案调整信息、上市时间短、注册类型为1~6类中成药或Ⅰ类中药创新药/Ⅲ类古代经典名方中药复方制剂、生产企业申报当年在“中国医药工业百强企业榜单”的中成药更有可能进入国家医保目录(P<0.05);多因素Logistic回归分析结果显示差异暂不显著,逐步回归与单因素分析的结果显示出较好的一致性。敏感性分析结果与基础分析呈现出相同趋势。建议中成药企业进一步明确对产品说明书内容的描述,增强创新能力,传承发展古代经典名方,并及时完善临床试验证据。

OBJECTIVE To analyze the factors affecting the inclusion of Chinese patent medicines in China’s National reimbursement drug list(NRDL),and assist these medicines in fully reflecting their actual value in the reimbursement admission process.METHODS From the official website of the China’s National Healthcare Security Administration,the application materials of Chinese patent medicines outside the list that passed the formal review from 2021 to 2023 were obtained,including basic information on the medicines,safety,efficacy,innovation and heritage information,and supplemented with references from the pharmacopeia and the Yaozhi Database.Economic information and enterprise information were obtained through websites such as the Yaozhi Database.Univariate analysis,multivariate Logistic regression analysis and stepwise regression analysis were conducted on the initial application information and admission outcomes of the medicines.Sensitivity analysis was also performed on medicines that applied multiple times in different years as independent samples.RESULTS&CONCLUSIONS There were 27 Chinese patent medicines that passed the formal review from 2021 to 2023,involving 37 applications.The univariate analysis results showed that medicines with descriptions of traditional Chinese medicine(TCM)syndrome types,clear adjustment information for medication plans for specific population groups,short time to market in the indications of the package insert,registered as Class 1 to 6 following or classⅠinnovative TCM/classⅢancient classic prescription compound TCM registered,and those produced by enterprises listed in the“Top 100 Chinese Pharmaceutical Industry Enterprises”list for the current year were more likely to be included in the NRDL(P<0.05).The results of the multivariate Logistic regression analysis were not statistically significant,but the stepwise regression results indicated good consistency with the univariate analysis.The results of the sensitivity analysis were consistent with the trend of basic analysis.It is recommended that Chinese patent medicine enterprises further clarify the description of product instructions,expand innovation capabilities,inherit and develop ancient classic prescriptions,and promptly complete clinical trial evidence.