抗体-药物偶联物(adc)在乳腺癌患者中的经济评价:系统评价。

IF 2.7 3区 医学 Q3 PHARMACOLOGY & PHARMACY
Mohammad Ali Rezaei, Hamid Pourasghari, Fereshte Karimi, Soheila Rajaie, Amirreza Shahmohammady, Masoud Behzadifar, Amir Hossein Dehqan, Samad Azari
{"title":"抗体-药物偶联物(adc)在乳腺癌患者中的经济评价:系统评价。","authors":"Mohammad Ali Rezaei, Hamid Pourasghari, Fereshte Karimi, Soheila Rajaie, Amirreza Shahmohammady, Masoud Behzadifar, Amir Hossein Dehqan, Samad Azari","doi":"10.1007/s00228-025-03915-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Metastatic breast cancer (mBC) is a major global health challenge. Antibody-drug conjugates (ADCs), including trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), and sacituzumab govitecan (SG), offer clinical benefits but are associated with high costs, making cost-effectiveness assessments essential for policy decisions.</p><p><strong>Methods: </strong>This systematic review analyzed economic evaluations comparing T-DM1, T-DXd, and SG with conventional treatments in breast cancer. A search of four databases and gray Literature up to November 2024 included studies reporting ICERs, QALYs, and LYGs. Data were extracted per PRISMA and CHEERS guidelines.</p><p><strong>Results: </strong>Twenty-nine studies from the USA, China, Brazil, Germany, Finland, Singapore, and Canada were reviewed. In the USA, ICERs for T-DXd ranged from $194,424/QALY (HR-) to $406,900/QALY, often exceeding WTP thresholds ($100K-$200K). It was cost-effective in HR- patients and those with good ECOG. In China, ICERs > $50,000/QALY exceeded the national threshold (~ $36,475/QALY). In Finland, T-DXd was cost-effective vs. T-DM1 (€55,360/QALY). T-DM1 was cost-effective in Canada (-$3,844/QALY) and select U.S. studies, but not in Brazil ($99,699/QALY) or China. Drug pricing was a key driver; U.S. results varied, perhaps due to modeling differences and sponsor bias. SG was not cost-effective in any country. ICERs ranged from $237,816/QALY (Singapore) to > $1.3 million/QALY (USA). In China, the cost-effectiveness probability was 0% at current prices.</p><p><strong>Conclusion: </strong>T-DXd and T-DM1 may be cost-effective in select groups and high-income countries. SG is not cost-effective anywhere. Drug prices are the main determinant of value, highlighting the need for price negotiations and more regional studies.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Economic evaluation of antibody-drug conjugates (ADCs) in patients with breast cancer: systematic review.\",\"authors\":\"Mohammad Ali Rezaei, Hamid Pourasghari, Fereshte Karimi, Soheila Rajaie, Amirreza Shahmohammady, Masoud Behzadifar, Amir Hossein Dehqan, Samad Azari\",\"doi\":\"10.1007/s00228-025-03915-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Metastatic breast cancer (mBC) is a major global health challenge. Antibody-drug conjugates (ADCs), including trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), and sacituzumab govitecan (SG), offer clinical benefits but are associated with high costs, making cost-effectiveness assessments essential for policy decisions.</p><p><strong>Methods: </strong>This systematic review analyzed economic evaluations comparing T-DM1, T-DXd, and SG with conventional treatments in breast cancer. A search of four databases and gray Literature up to November 2024 included studies reporting ICERs, QALYs, and LYGs. Data were extracted per PRISMA and CHEERS guidelines.</p><p><strong>Results: </strong>Twenty-nine studies from the USA, China, Brazil, Germany, Finland, Singapore, and Canada were reviewed. In the USA, ICERs for T-DXd ranged from $194,424/QALY (HR-) to $406,900/QALY, often exceeding WTP thresholds ($100K-$200K). It was cost-effective in HR- patients and those with good ECOG. In China, ICERs > $50,000/QALY exceeded the national threshold (~ $36,475/QALY). In Finland, T-DXd was cost-effective vs. T-DM1 (€55,360/QALY). T-DM1 was cost-effective in Canada (-$3,844/QALY) and select U.S. studies, but not in Brazil ($99,699/QALY) or China. Drug pricing was a key driver; U.S. results varied, perhaps due to modeling differences and sponsor bias. SG was not cost-effective in any country. ICERs ranged from $237,816/QALY (Singapore) to > $1.3 million/QALY (USA). In China, the cost-effectiveness probability was 0% at current prices.</p><p><strong>Conclusion: </strong>T-DXd and T-DM1 may be cost-effective in select groups and high-income countries. SG is not cost-effective anywhere. Drug prices are the main determinant of value, highlighting the need for price negotiations and more regional studies.</p>\",\"PeriodicalId\":11857,\"journal\":{\"name\":\"European Journal of Clinical Pharmacology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-09-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Clinical Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00228-025-03915-6\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00228-025-03915-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

转移性乳腺癌(mBC)是一个主要的全球健康挑战。抗体-药物偶联物(adc),包括曲妥珠单抗emtansine (T-DM1),曲妥珠单抗deruxtecan (T-DXd)和sacituzumab govitecan (SG),提供临床益处,但与高成本相关,使得成本效益评估对政策决策至关重要。方法:本系统综述分析了T-DM1、T-DXd和SG与乳腺癌常规治疗的经济评价。截至2024年11月,我们检索了四个数据库和灰色文献,包括报告ICERs、QALYs和LYGs的研究。根据PRISMA和CHEERS指南提取数据。结果:对来自美国、中国、巴西、德国、芬兰、新加坡和加拿大的29项研究进行了综述。在美国,T-DXd的ICERs从194,424美元/QALY (HR-)到406,900美元/QALY不等,通常超过WTP阈值(10万美元- 20万美元)。在HR-患者和ECOG良好的患者中,它具有成本效益。在中国,ICERs的收入为5万美元/QALY,超过了国家标准(约36,475美元/QALY)。在芬兰,与T-DM1相比,T-DXd更具成本效益(55360欧元/QALY)。T-DM1在加拿大(- 3,844美元/QALY)和部分美国研究中具有成本效益,但在巴西(99,699美元/QALY)或中国没有成本效益。药品定价是一个关键驱动因素;美国的结果有所不同,可能是由于建模差异和赞助商偏见。SG在任何国家都没有成本效益。ICERs从237,816美元/QALY(新加坡)到130万美元/QALY(美国)不等。在中国,按当前价格计算,成本效益概率为0%。结论:T-DXd和T-DM1在特定人群和高收入国家可能具有成本效益。SG在任何地方都不划算。药品价格是价值的主要决定因素,这突出表明需要进行价格谈判和更多的区域研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Economic evaluation of antibody-drug conjugates (ADCs) in patients with breast cancer: systematic review.

Introduction: Metastatic breast cancer (mBC) is a major global health challenge. Antibody-drug conjugates (ADCs), including trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), and sacituzumab govitecan (SG), offer clinical benefits but are associated with high costs, making cost-effectiveness assessments essential for policy decisions.

Methods: This systematic review analyzed economic evaluations comparing T-DM1, T-DXd, and SG with conventional treatments in breast cancer. A search of four databases and gray Literature up to November 2024 included studies reporting ICERs, QALYs, and LYGs. Data were extracted per PRISMA and CHEERS guidelines.

Results: Twenty-nine studies from the USA, China, Brazil, Germany, Finland, Singapore, and Canada were reviewed. In the USA, ICERs for T-DXd ranged from $194,424/QALY (HR-) to $406,900/QALY, often exceeding WTP thresholds ($100K-$200K). It was cost-effective in HR- patients and those with good ECOG. In China, ICERs > $50,000/QALY exceeded the national threshold (~ $36,475/QALY). In Finland, T-DXd was cost-effective vs. T-DM1 (€55,360/QALY). T-DM1 was cost-effective in Canada (-$3,844/QALY) and select U.S. studies, but not in Brazil ($99,699/QALY) or China. Drug pricing was a key driver; U.S. results varied, perhaps due to modeling differences and sponsor bias. SG was not cost-effective in any country. ICERs ranged from $237,816/QALY (Singapore) to > $1.3 million/QALY (USA). In China, the cost-effectiveness probability was 0% at current prices.

Conclusion: T-DXd and T-DM1 may be cost-effective in select groups and high-income countries. SG is not cost-effective anywhere. Drug prices are the main determinant of value, highlighting the need for price negotiations and more regional studies.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
5.40
自引率
3.40%
发文量
170
审稿时长
3-8 weeks
期刊介绍: The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信