集采和国谈背景下原研与仿制新型抗肿瘤药应用分析OA
Application Analysis of Original and Generic Novel Antineoplastic Drugs Under the Background of Centralized Procurement and National Medical Insurance Negotiation
目的 为医保支付与药品集中带量采购(简称集采)政策及用药管理优化提供参考.方法 基于中国药学会全国医药信息网及国家药品监督管理局、国家医疗保障局官网数据,纳入 2019-2023 年全国 859 家样本医院 15 种新型抗肿瘤药物(含原研药与仿制药)的基本信息[包括药物名称、价格、规格、剂型,上市/国家医保药品谈判(简称国谈)/集采/纳入医保目录时间,医保限定信息等],计算其使用金额、用药频度(DDDs)、限定日费用(DDDc)及使用金额排序/DDDs排序比值(B/A),并进行比较,评估国谈和集采政策干预效果.结果 研究期间各原研药的使用金额和DDDs整体呈下降趋势,其中,使用金额从 62.36 亿元降至 29.28 亿元,DDDs从 1.69×107 降至 0.93×107;而仿制药的使用金额和DDDs持续增长,其中,使用金额从 6.20 亿元升至 43.07 亿元,DDDs从0.67×107 升至 2.86×107;2021 年起,仿制药DDDs首次超过原研药;2022 年起,仿制药使用金额首次超过原研药;除 2019 年的阿比特龙外,原研药DDDc均高于仿制药;大部分药物原研药与仿制药的B/A≥1;其中 10 种药物在国谈、集采或纳入医保目录后出现DDDs增长,部分药物在相应年份的增长率超过 1000%.大部分调研药物的原研药与仿制药DDDc值在研究期内呈下降或基本持平的趋势.结论 随着国谈和集采政策的持续推进,与原研药比较,仿制药在价格和可及性上的优势逐渐显现,临床使用量持续增长,且价格-使用匹配度较好,可为进一步优化抗肿瘤药物医保准入与使用提供依据.
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.
杨晴晴;李伟;陆伟;叶露;陈红斗;余欢欢;周子亮;张晗;林奇泗
徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州生物工程职业技术学院药品食品学院,江苏 徐州 221000徐州医科大学附属宿迁医院·南京鼓楼医院集团宿迁医院,江苏 宿迁 223800徐州医科大学药学院,江苏 徐州 221000徐州医科大学药学院,江苏 徐州 221000
医药卫生
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
novel antineoplastic drugsoriginal druggeneric drugconsumption sumdefined daily dosesdefined daily dose cost
《中国药业》 2026 (6)
7-13,7
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].
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