目的: 系统分析国家组织开展的四次（包括三批国采和一批接续）高值医用耗材集中带量采购规则与中选结果,以研判我国高值医用耗材集中带量采购趋势与走向。方法: 通过分析三批国采文件与一批接续文件,从带量比例、分组规则、报价规则、中选规则与分量规则五个方面对比采购规则;并从中选价格与中选企业两个方面分析中选结果,归纳总结出我国高值医用耗材集中带量采购趋势和走向。结果: 根据规则对比可知,四次国采带量比例提升;分组体现“同质同组竞争”;价格组成更为细致;中选规则趋于稳定临床供应;分量规则体现“以量换价”。根据中选结果分析可知,中选降幅收敛于80%;中选价差逐渐缩小至1.5倍以下;国采品种国产占有率稳步提升;国产替代进一步加强;企业中选率逐步提升并稳定在90%;头部企业均中选;产业集中度进一步提升。结论: 结合上述分析与集采现状,归纳出我国高值医用耗材集中带量采购的七个趋势,即采购规则设计更注重于保障市场的稳定性;采购范围不断扩大,品种逐渐无禁区;形成上下联动、协同推进的医药集中带量采购新格局;多项举措配合集采迈向价格综合治理新征程;聚焦低国产化领域,国产替代进程加快;集采正向促进企业创新,实现医药行业高质量方向发展;集采协同“三医联动”推进医药健康发展。

Objective: The paper systematically analyzes the four batches (including three batches of national procurement and a batch of follow-up procurement) of national high-value medical consumables centralized volume-based procurement rules and selected results, in order to reflect the trend of China's high-value medical consumables centralized volume-based procurement. Methods: By analyzing the four batches of procurement documents, the procurement rules are compared from five aspects, i.e. the proportion of intended procurement, grouping rules, quotation rules, selection rules, and volume allocation rules. Also we analyze the selected results from two aspects of selected price and selected enterprises and summarize the trend of centralized volume-based procurement of high-value medical consumables in China. Results: According to comparison of the rules, the proportion of intended procurement is increasing, grouping rules reflect homogeneous competition in the same group, the price composition becomes more detailed, selection rules tend to stabilize the clinical supply, and volume allocation rules reflect quantity-price linkage. According to the selected results, the prices of selected drugs decrease to 80%, the difference of selected price gradually narrows to less than 1.5 times, the domestic share of national varieties steadily increases, domestic substitution further strengthens, the selected rate of enterprises gradually increases and stabilizes at 90%, the leading enterprises are selected and the industry concentration further increases. Conclusion: Combining the analysis above with the current situation of the procurement, the paper summarizes the seven trends of high-value medical consumables centralized volume-based procurement in China, namely, procurement rules design is more focused on the protection of market stability, procurement scope continues to expand and almost all varieties can be selected, we form a new pattern of pharmaceutical centralized volume-based procurement with collaborative promotion, a number of initiatives support the procurement to move towards a new journey of comprehensive price management, varieties focus on low localization rate areas and domestic replacement process accelerated, centralized procurement promotes enterprise innovation and realizes the high-quality development of pharmaceutical industry, centralized procurement synergy "medical insurance-medical treatment-drugs linkage" to promote the development of pharmaceutical industry.