国家组织药品集中带量采购价格降幅影响因素分析

Analysis on influencing factors of price reduction in national volume-based drug procurement

目的:分析国家组织药品集中带量采购过程中生产企业是否中选及中选价格的影响因素,探讨带量采购政策效果及是否仍有提升空间。方法:选取第二批至第五批药品集中带量采购涉及品种进行分析,以中选企业是否中选以及价格降幅为因变量,企业特征和竞争因素相关指标为自变量,采用Heckman两阶段模型分析药品价格降幅及是否中选的影响因素,并控制潜在的选择偏倚。结果:原研企业相较于仿制药企业中选概率更低,但是一旦中选其价格降幅相较于仿制药企业高41%;市场份额较小企业相较于原有市场份额较高企业(>50%)中选概率更大,但价格降幅低7%;具备原料药生产加工资质的企业更易中选,但是价格降幅相较于不具备相关资质企业没有显著差异;潜在竞争者数量每增加1%,中选价格降幅增加0.26个百分点,企业中选概率也更低。结论:药品带量采购可以有效促进原研药产生“专利悬崖”现象,理顺药品价格形成机制。具备原料药生产加工资质的企业体现出更强的成本控制能力。同时,在规则设计中可以进一步突出保障供应在中标规则中的重要性、制定动态触发机制或者尝试建立组合投标机制,有利于进一步运用市场机制降低药品价格。

Objectives:To analyze the influencing factors on price reduction in national volume-based procurement(NVBP)in China,so as to investigate the effect of NVBP and probable improvements.Methods:The varieties involved in the 2nd~5th rounds of NVBP were selected for analysis.Taking whether the bid-winning enterprise was selected or not and the price decline as dependent variables,and the related indicators of enterprise characteristics and competitive factors as independent variables,Heckman two-stage model was used to analyze the influencing factors of drug price decline and whether it was selected or not and control the potential selection bias.Results:Manufacturers of brand drugs are less likely to become bid-winner but their price reduction is 41%higher than manufacturers of generics.Small enterprises with smaller market shares have a higher probability of winning compared with the original enterprises with higher market share(>50%),but the price drop is 7%lower.Manufactures with the ability to extract active pharmaceutical ingredients from raw materials are more likely to win but no significant difference in price reduction was observed.When potential competitors in the group increased by 1%,the price reduction increased by 0.26 percentage points and companies are less likely to win.Conclusion:VBP program can effectively promote the appearance of the“patent cliff”in China and rationalize the pricing mechanism of drugs.However,more importance could be attached to improve supply security and the establishment of a dynamic trigger or multiple bidding mechanism,which can further lower prices under market mechanisms.