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中国、日本和韩国抗癌药物的标价与临床价值:一项回顾性比较研究。

List prices and clinical value of anticancer drugs in China, Japan, and South Korea: a retrospective comparative study.

作者信息

Pan Jay, Wei Xiaolin, Lu Hao, Wu Xueer, Li Chunyuan, Hai Xuelian, Lan Tianjiao, Dong Quanfang, Yang Yili, Jakovljevic Mihajlo, Zhou Jing

机构信息

HEOA Group, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.

Institute for Healthy Cities and West China Research Center for Rural Health Development, Sichuan University, Chengdu, China.

出版信息

Lancet Reg Health West Pac. 2024 May 16;47:101088. doi: 10.1016/j.lanwpc.2024.101088. eCollection 2024 Jun.

Abstract

BACKGROUND

High prices of anticancer drugs have raised concerns due to their financial impact on patients and healthcare systems. This study aimed to assess the initial and latest list prices and clinical value of reimbursed anticancer drugs in China, Japan, and South Korea.

METHODS

We identified anticancer drugs newly approved by the National Medical Products Administration of China from January 2012 to June 2022, and by the Pharmaceuticals and Medical Devices Agency of Japan and the Ministry of Food and Drug Safety of South Korea up until June 2022. We compared initial and latest treatment prices between countries and assessed clinical value using patients' survival, quality of life (QoL), and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). We calculated Spearman rank correlation coefficients of treatment prices with clinical value for individual countries and employed regression analyses to investigate whether the relationship between prices and clinical value was modified by the country setting.

FINDINGS

Our cohort included 91 anticancer drug indications, with 60 listed for reimbursement in China, 91 in Japan, and 87 in South Korea. Median treatment prices were highest in Japan, followed by South Korea, and lowest in China, both for initial prices (US$64082 vs. US$45529 vs. US$19144, p < 0.0001) and latest prices (US$50859 vs. US$31611 vs. US$18666, p < 0.0001). Over time, China ( = -0.047, p < 0.0001) and South Korea ( = -0.049, p < 0.0001) witnessed more significant price reductions compared to Japan ( = -0.013, p = 0.011). The correlations between both initial and latest treatment prices and clinical value (QoL and ESMO-MCBS) were more significant and stronger in China and South Korea than in Japan, although Japan exhibited slightly stronger correlations in terms of survival compared to China and South Korea. The relationship between clinical value and treatment prices may not be modified by the country setting.

INTERPRETATION

In comparison, South Korea's list prices and their correlations with clinical value appear reasonable. Policymakers in Japan could enhance efficiency by controlling prices and aligning them with clinical value, while China would need to take substantial steps to expand anticancer drug coverage.

FUNDING

National Natural Science Foundation of China (72374149 and 72074163), and China Center for South Asian Studies, Sichuan University.

摘要

背景

抗癌药物的高价格因其对患者和医疗保健系统的经济影响而引发关注。本研究旨在评估中国、日本和韩国已报销抗癌药物的初始和最新标价以及临床价值。

方法

我们确定了中国国家药品监督管理局在2012年1月至2022年6月期间新批准的抗癌药物,以及日本药品和医疗器械管理局及韩国食品药品安全部截至2022年6月新批准的抗癌药物。我们比较了各国之间的初始和最新治疗价格,并使用患者生存率、生活质量(QoL)和欧洲医学肿瘤学会临床获益程度量表(ESMO-MCBS)评估临床价值。我们计算了各国治疗价格与临床价值之间的Spearman等级相关系数,并采用回归分析来研究价格与临床价值之间的关系是否因国家背景而有所不同。

研究结果

我们的队列包括91种抗癌药物适应症,其中60种在中国列入报销目录,91种在日本,87种在韩国。初始价格和最新价格方面,日本的中位治疗价格最高,其次是韩国,中国最低(初始价格分别为64082美元、45529美元和19144美元,p<0.0001;最新价格分别为50859美元、31611美元和18666美元,p<0.0001)。随着时间推移,与日本(r=-0.013,p=0.011)相比,中国(r=-0.047,p<0.0001)和韩国(r=-0.049,p<0.0001)的价格降幅更大。在中国和韩国,初始和最新治疗价格与临床价值(QoL和ESMO-MCBS)之间的相关性比日本更显著且更强,不过在生存率方面,日本与中国和韩国相比,相关性略强。临床价值与治疗价格之间的关系可能不会因国家背景而有所不同。

解读

相比之下,韩国的标价及其与临床价值的相关性似乎较为合理。日本的政策制定者可以通过控制价格并使其与临床价值保持一致来提高效率,而中国则需要采取重大措施来扩大抗癌药物的覆盖范围。

资金来源

中国国家自然科学基金(72374149和72074163),以及四川大学南亚研究所中国中心。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2da6/11107456/4841c1653b22/gr1.jpg

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