仿制药替代潜在最大费用节省研究

目的在仿制药替代背景下,比较原研药和仿制药的价格和采购量,测算仿制药替代的潜在最大费用节省,推动仿制药供应与使用。方法基于陕西省药品招标采购数据,选取2017年12月第一批通过仿制药质量和疗效一致性评价的17个品种(16个品规)药品,对其2017年至2018年的价格、采购量进行分析;采用成本分析法、推测预算法,对采购平台上该通用名、剂型的药品替换为通过仿制药质量和疗效一致性评价单价最低的仿制药,测算年均仿制药替代的潜在最大费用节省。结果价格由高到低依次为原研药、未通过一致性评价的仿制药、通过一致性评价的仿制药;采购量方面,5个品规药品的原研药采购量占比较高,11个品规药品的仿制药采购量占比较高,1个品规药品未发生仿制药替代;对16个品规药品进行仿制药替代后,测算出潜在最大费用节省为3243.63万元。结论仿制药替代可显著节省药品费用,我国的仿制药市场提升空间较大,后续应加快推进仿制药一致性评价和临床使用。

Potential Maximum Cost Savings of Generic Substitution

Objective To compare the price and purchase volume of brand drugs and generic drugs accurately,measure the potential maximum cost savings of generic substitution,and promote the supply and use of generic drugs under the background of generic substitution.Methods Based on the data of drug bidding and purchase in Shaanxi Province,t he price and purchase volume from 2017 to 2018 of the first batch of 17 drugs(16 specifications)approved by generic consistency evaluation(GCE)at the end of December 2017 were analyzed;by using the method of cost analysis and budget prediction methods,all drugs with the same the generic name and dosage form on the procurement platform were substituted with the lowest unit price of generic ones that were approved by GCE,and the potential maximum cost savings for annual generic substitution were estimated.Results In terms of price,the high to low price rank was brand drugs,generic drugs that were not approved by GCE,and generic ones that were approved by GCE.In terms of purchase volume,5specifications had higher brand drug proportion and 11 specifications had higher generic drug proportion;1 specification had no generic substitution.The cost savings of the 16 specifications was 32.4363 million yuan.Conclusion Generic substitution can save drug costs greatly.China still has great potentials for the market of generic drugs,and the policy of GCE and clinical application should be promoted.