[1]王佳玮sup>,徐俊芳.外部参考定价在我国创新药医保准入中的应用研究[J].卫生经济研究,2025,42(09):29-33.
　WANG Jiawei,XU Junfang.Research on the Application of External Reference Pricing in Innovative Drug Medical Insurance Access in China[J].Journal Press of Health Economics Research,2025,42(09):29-33.
点击复制

外部参考定价在我国创新药医保准入中的应用研究

卫生经济研究[ISSN:1004-7778/CN:33-1056/F]

卷:
42
期数:
2025年09期
页码:
29-33
栏目:
他山之石
出版日期:
2025-08-28

文章信息/Info

Title:
Research on the Application of External Reference Pricing in Innovative Drug Medical Insurance Access in China
作者:
王佳玮sup>1; 徐俊芳1; 2
1.浙江大学公共卫生学院，浙江大学医学部卫生政策学研究中心，浙江 杭州 310058
2.浙江大学医学院附属第二医院，浙江 杭州 310009
Author(s):
WANG Jiawei;  XU Junfang
School of Public Health, Zhejiang University, Hangzhou Zhejiang 310058, China
关键词:
外部参考定价; 创新药; 价值评估; 医保准入
Keywords:
external reference pricing;  innovative drugs;  value assessment;  medical insurance access
分类号:
R95；F840.684
文献标志码:
A
摘要:
目的：研究外部参考定价（ERP）在我国创新药医保准入中的应用。方法：通过政策分析和文献研究，系统梳理日本、法国、韩国等国家ERP应用情况，探讨ERP与创新药价值评估的联动应用。结果：ERP作为辅助工具，与临床效益评估、成本核算等工具共同应用于创新药医保准入定价；参考国家的选取是ERP的关键，“国家篮子”的经济水平、定价方式等会影响定价的准确性。结论：ERP在创新药定价中发挥了重要作用，但作用程度不一；我国对ERP的应用，需紧密结合药品定价政策，综合考虑药品的研发成本、市场需求等因素，避免盲目套用国际标准；为抵消创新药在不同人群中临床价值的内生差异，还需根据参考国家药物价值评估方案，结合临床试验数据和药品费用数据，对拟入医保的创新药进行价值评估和预算影响分析，从而实现创新药定价和医保支付能力之间的平衡。
Abstract:
Objective To investigate the application of External Reference Pricing(ERP) in innovative drug medical insurance access in China. Methods Through policy analysis and literature research, the application of ERP in several countries/regions was systematically sorted out, and the linkage application of ERP and value assessment of innovative drugs was explored. Results As an auxiliary tool, ERP was used alongside clinical benefit assessments and cost accounting in the pricing strategies for innovative drugs. The selection of reference countries/regions was a key element of ERP, and economic level and pricing method affected the accuracy of pricing. Conclusion ERP plays an important role in the pricing of innovative drugs, but the extent of its role varies. In China, the application of ERP needs to be closely integrated with the drug pricing policy, taking into account the research and development cost of drugs, market demand and other factors, and avoiding the blind application of international standards. In order to offset the endogenous differences in clinical value of innovative drugs among different populations, it is necessary to evaluate the value and budget impact of innovative drugs proposed for inclusion in medical insurance in accordance with the value assessment program of the drug in the reference countries/regions, combined with clinical trial data and drug cost data, so as in to achieve a balance between innovative drug pricing and medical insurance payment ability.

参考文献/References:

[1] 科睿唯安.2022年医药研发趋势年度分析[EB/OL].[2024-03-05].https://ipis.cpu.edu.cn/77/e1/c1251a161761/page.htm.
[2] Garon E B,Hellmann M D, Rizvi N A,et al. Five-year overall survival for patients with advanced non-small-cell lung cancer treated with Pembrolizumab: results from the phase I KEYNOTE-001 study[J].Journal of Clinical Oncology:Official Journal of the American Society of Clinical Oncology,2019,37(28):2518-2527.
[3] 胡善联.中国医保药品价格谈判回顾和展望[J].卫生经济研究， 2024，41（01）：9-13.
[4] 国家医疗保障局统计数据.2022年医疗保障事业发展统计快报[EB/OL].[2024-12-17].https://www.nhsa.gov.cn/art/2023/3/9/art_7_ 10250.html.
[5] 国家医疗保障局 统计数据.2023年医疗保障事业发展统计快报[EB/OL].[2024-12-17].https://www.nhsa.gov.cn/art/2024/4/11/art_ 7_12348.html.
[6] 沈秋欢.药品参考价格制度典型国家创新药品定价与补偿机制[J].中国新药杂志，2017，26（14）：1612-1617.
[7] External reference pricing of medicinal products: simulation-based considerations for cross-country coordination-European Commission[EB/OL].[2024-03-25].https://health.ec.europa.eu/latest-updates/externa-reference-pricing-medicinal-products-simulation-based-considerations-cross-country-2014-03-10_en.
[8] Zaheer-Ud-Din Babar.Encyclopedia of Pharmacy Practice and Clinical Pharmacy[M].Academic Press,2019.
[9] Policy Brief 1—External Reference Pricing[EB/OL].[2024-03-25].https://haiweb.org/media-resource/policy-brief-1-external-reference-pricing.
[10] 王亮，李爱花，岳晓萌，等.日本药品价格制度研究及对我国药品价格管理的启示[J].中国卫生经济，2017，36（10）：87-91.
[11] 中国中药协会.药品定价原则酝酿调整[EB/OL].[2024-06-02].https://www.catcm.org.cn/129/200709/697.html.
[12] 范长生，赵蒙蒙，谢洋，等.关于医保谈判药品价值评估和支付标准形成的若干探讨[J].中国医疗保险，2020（11）：73-77.
[13] 常峰， 李思函.药品国际参考定价制度对我国的启示——以加拿大、荷兰、日本三国为例[J].价格理论与实践，2013（07）：62-63.
[14] Sullivan S D,Sullivan K D,Dabbous O,et al.International reference pricing of pharmaceuticals in the United States: implications for potentially curative treatments[J].Journal of Managed Care & Specialty Pharmacy,2022,28(05):566-572.
[15] Rand L Z,Kesselheim A S.International reference pricing for prescription drugs in the United States:administrative limitations and collateral effects[J].Value in Health:the Journal of the International Society for Pharmacoeconomics and Outcomes Research, 2021,24(04): 473-476.

相似文献/References:

[1]付瑞枫,茅宁莹.“双通道”背景下国谈创新药零售终端流通现状[J].卫生经济研究,2023,40(2):24.
　FU Ruifeng,MAO Ningying.Analysis on the Circulation and Obstacles of Innovative Drugs in Retail Terminal under the Dual-channel Policy in China[J].Journal Press of Health Economics Research,2023,40(09):24.
[2]谭清立,李永盈,崔洪瑞.创新药医保谈判的博弈分析[J].卫生经济研究,2024,41(06):5.
　TAN Qingli,LI Yongying,CUI Hongrui.Game Analysis of Health Insurance Negotiation for Innovative Drug[J].Journal Press of Health Economics Research,2024,41(09):5.
[3]赵舸争,夏 凡,方心悦,等.创新药和创新医疗技术临床使用的影响因素：系统综述[J].卫生经济研究,2026,43(01):8.
　ZHAO Gezhen,XIA Fan,FANG Xinyue,et al.Systematic Review on the Factors Influencing the Clinical Application of Innovative Drugs and Medical Technologies[J].Journal Press of Health Economics Research,2026,43(09):8.
[4]王闻萱,赵力佳,唐跃洺.耐心资本赋能创新药产业发展的内在机理与实现路径[J].卫生经济研究,2026,43(04):21.
　WANG Wenxuan,ZHAO Lijia,TANG Yueming.The Internal Mechanism and Realization Path of Patient Capital in Empowering the Development of the Innovative Drug Industry[J].Journal Press of Health Economics Research,2026,43(09):21.
[5]马振涛,文晓初,郎 堃.“三医”协同体系下商业健康险支持创新药发展：模式、问题与建议[J].卫生经济研究,2026,43(04):25.
　MA Zhentao,WEN Xiaochu,LANG Kun.Commercial Health Insurance Supporting Innovative Drug Development under the "Three Medical" Collaborative System: Models, Issues and Recommendations[J].Journal Press of Health Economics Research,2026,43(09):25.

更新日期/Last Update: 2025-08-28