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}
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.
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.
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