中成药集中带量采购分组规则对比研究

Comparative study on grouping rules in centralized volume-based procurement of Chinese Patent Medicine

目的:系统梳理全国及各省、市(区)中成药集中带量采购(以下简称集采)有关政策文件,对比分析各地集采分组规则和方法,为完善我国中成药集采分组规则提供借鉴。方法:通过文献分析法和比较分析法,对纳入研究的22个政策文本进行深入分析,总结全国及省际联盟中成药集采的进展情况。结果:全国和省际联盟中成药集采按照功能主治、给药途径、市场情况划分采购组,分组规则与药品剂型及质量的关联度不高;根据市场竞争格局划分竞价组别,忽视了部分中成药的创新价值,亦未考虑企业及其产品特有的品牌价值和中医药文化传播能力,分组规则的完备性有待提升。结论:中成药剂型繁多,质量控制指标复杂,现有分组规则沿用化学药集采分组思路,缺乏以中成药价值为导向的顶层设计。建议采取多元分组方式,将现有入围规则中的技术评价“前置”,即在制定分组规则时考虑药品剂型、质量、创新价值、弘扬中医药文化等因素,并对分组规则做进一步完善与细化。

Objective:Comprehensively review national and provincial policies related to centralized procurement of Chinese Patent Medicines(CPM)and to compare the grouping rules and methods of centralized procurement in different regions,with the goal of providing guidance for enhancing the grouping rules for CPM.Methods:Through literature analysis and comparative analysis,the 22 policies included in the study were analyzed in depth,and the progress of centralized volume-based procurement of CPM in national and inter-provincial alliances was compared and summarized.Results:National and inter-provincial alliances’centralized volume-based procurement of CPM divides procurement groups according to functional indications,route of administration,and market conditions.The grouping rules are not closely related to drug dosage forms and quality.Dividing bidding groups based on the market competition pattern ignores the innovative value of some CPM,and does not take into account the unique brand value of the company and its drugs.The completeness of the grouping rules needs to be improved.Conclusions:There are many dosage forms of CPM and complex quality control indicators.The existing grouping rules follow the idea of grouping chemical drugs and lack a top-level design oriented to the value of CPM.It is recommended to adopt a diversified grouping method and advance the technical evaluation link in the existing shortlisting rules.This means that factors such as drug dosage form,quality and innovation value should be considered when formulating grouping rules.At the same time,it is necessary to improve and refine the current grouping rules.