中国药业2026，Vol.35Issue(6)：7-13,7.DOI:10.3969/j.issn.1006-4931.2026.06.002
集采和国谈背景下原研与仿制新型抗肿瘤药应用分析
Application Analysis of Original and Generic Novel Antineoplastic Drugs Under the Background of Centralized Procurement and National Medical Insurance Negotiation
摘要
Abstract
Objective To provide a reference for the optimization of medical insurance payment and centralized drug volume-based procurement(referred to as centralized procurement)policy and drug management.Methods Based on the data from the National Pharmaceutical Information Network of the Chinese Pharmaceutical Association and the official websites of the National Medical Products Administration and the National Healthcare Security Administration,the basic information of 15 novel antineoplastic drugs(including original and generic drugs)from 859 sample hospitals in China from 2019 to 2023[including drug name,price,specification,dosage form,time of market launch/national medical insurance negotiation(hereinafter referred to as the national negotiation)/centralized procurement/inclusion in medical insurance listing,medical insurance restrictive information]were included,the consumption sum,defined daily doses(DDDs),defined daily dose cost(DDDc)and ratio of consumption sum ranking to DDDs ranking(B/A)values of which were calculated and compared to evaluate the intervention effect of the national negotiation and centralized procurement policy.Results During the study period,the consumption sum and DDDs of original drugs showed an overall downward trend,in which the consumption sum decreased from CNY 6.236 billion to CNY 2.928 billion,and DDDs decreased from 1.69×107 to 0.93×107;but the consumption sum and DDDs of generic drugs increased continuously,in which the consumption sum increased from CNY 0.620 billion to CNY 4.307 billion,and DDDs increased from 0.67×107 to 2.86×107.Since 2021,DDDs of generic drugs exceeded those of original drugs for the first time;since 2022,the consumption sum of generic drugs exceeded those of the original drugs for the first time;except for abiraterone in 2019,the DDDc of the original drugs was higher than that of generic drugs.The B/A of most original and generic drugs were≥1.DDDs of 10 kinds of drugs increased after national negotiation,centralized procurement or inclusion in the medical insurance listing,and the growth rate of some drugs in the corresponding years exceeded 1 000%.The DDDc value of the original drugs and generic drugs of most investigational drugs showed a downward or basically flat trend during the study period.Conclusion With the continuous promotion of the national negotiation and centralized procurement policy,compared with the original drugs,the advantages of generic drugs in terms of price and accessibility have gradually emerged,the clinical use continues to grow,and the price-use matching degree is good,which can provide a basis for further optimizing the medical insurance access and use of antineoplastic drugs.关键词
新型抗肿瘤药/原研药/仿制药/使用金额/用药频度/限定日费用Key words
novel antineoplastic drugs/original drug/generic drug/consumption sum/defined daily doses/defined daily dose cost分类
医药卫生引用本文复制引用
杨晴晴,李伟,陆伟,叶露,陈红斗,余欢欢,周子亮,张晗,林奇泗..集采和国谈背景下原研与仿制新型抗肿瘤药应用分析[J].中国药业,2026,35(6):7-13,7.基金项目
江苏省新药研究与临床药学重点实验室开放研究课题[KFKT-2305] （）
江苏省宿迁市科学技术局市级指导性科技计划项目[Z2021114] （）
江苏省徐州市科技项目[KC25124] （）
徐州医科大学附属医院发展基金项目[XYFM202453]. （）
