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Reframing NICE's Cost-Effectiveness Threshold: Technical Benchmark or Policy Signal? A Documentary Content Analysis. 重构NICE的成本效益门槛:技术基准还是政策信号?纪录片内容分析。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-06 DOI: 10.1016/j.jval.2026.07.004
Hesam Ghiasvand, Seyran Naghdi
{"title":"Reframing NICE's Cost-Effectiveness Threshold: Technical Benchmark or Policy Signal? A Documentary Content Analysis.","authors":"Hesam Ghiasvand, Seyran Naghdi","doi":"10.1016/j.jval.2026.07.004","DOIUrl":"10.1016/j.jval.2026.07.004","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to examine how governmental, industry, academic, consultancy, journalistic, and international health technology assessment (HTA) stakeholders framed the cost-effectiveness threshold (CET) uplift announced for the National Institute for Health and Care Excellence (NICE) in December 2025 during the early phase of policy debate.</p><p><strong>Methods: </strong>A qualitative documentary content analysis was conducted following the READ framework (Ready your materials, Extract data, Analyse data, and Distil your findings) for systematic document analysis in health policy research. Twenty-seven publicly available documents published between October 2025 and March 2026 were purposively sampled across government, NICE, industry, academia, consultancy, journalism, civil society, and international HTA actors. Data were analyzed through iterative coding and thematic synthesis.</p><p><strong>Results: </strong>The 2025 to 2026 debate extended beyond technical discussions of cost-effectiveness and revealed 5 interrelated themes. First, government documents explicitly reframed the CET as an instrument of industrial policy, economic growth, and pharmaceutical competitiveness. Second, substantial disagreement emerged regarding HTA governance and ministerial involvement in threshold setting. Third, stakeholders advanced competing interpretations of the consequences of the reform, with government and industry emphasizing innovation access, whereas academic and public-interest sources highlighted opportunity costs, service displacement, and population-health impacts. Fourth, many documents situated the reform within broader geopolitical and pharmaceutical-policy dynamics, including trade negotiations, investment incentives, and potential international spillovers. Finally, stakeholders expressed contrasting views regarding transparency, consultation, and procedural legitimacy.</p><p><strong>Conclusions: </strong>The NICE threshold uplift was framed as a politically mediated reform with implications for industrial strategy, HTA governance, healthcare resource allocation, and public trust. The findings demonstrate how CETs can become sites of broader political, economic, and institutional contestation, extending beyond their conventional role within health-economic evaluation.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148685752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Swimming in the Sea of Real-World Evidence Guidance: Why More Guidance Will Not Help Researchers Swim. 在RWE指南的海洋中游泳:为什么更多的指导不会帮助研究人员游泳。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-06 DOI: 10.1016/j.jval.2026.06.026
Ashley Jaksa
{"title":"Swimming in the Sea of Real-World Evidence Guidance: Why More Guidance Will Not Help Researchers Swim.","authors":"Ashley Jaksa","doi":"10.1016/j.jval.2026.06.026","DOIUrl":"10.1016/j.jval.2026.06.026","url":null,"abstract":"<p><p>The global use of real-world data and real-world evidence (RWE) in regulatory and health technology assessment decisions has led to a crucial need for alignment on what constitutes high-quality RWE. Regulators, health technology assessment bodies, and professional societies have issued an abundance of guidance documents, resulting in a state of guidance oversaturation. The existence of multiple initiatives to track this guidance is itself indicative of the challenge researchers face in interpreting and aligning with decision-maker expectations. Although the proliferation of guidance forces researchers into exhaustive \"compare and contrast\" exercises, multiple publications have documented substantial alignment on core principles, including study design, data quality, the importance of fit-for-purpose data, and methodological rigor. For example, the fundamental requirements for real-world data quality are similar between the Food and Drug Administration and European Medicines Agency. This convergence suggests that additional, redundant guidance is not the answer to addressing remaining gaps. Instead of producing new, high-level guidance, future efforts should pivot toward 2 critical areas. First, global harmonization of existing guidance is necessary to reduce the resource burden on sponsors and prevent evidentiary fragmentation across jurisdictions. Second, a transparent, annotated repository of diverse case studies must be developed to build operational transparency in RWE use and decision making. This repository should capture why specific data and methodological decisions were made, how the evidence was evaluated, and how it was ultimately used in decision making. By shifting the focus from guidance to transparent, precedent-based learning and harmonized standards, the industry can establish a more predictable and efficient pathway for decision-grade RWE integration.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148685774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reasons for Distributional Preferences for Health Outcomes: A Mixed-Method Interview Study. 健康结果分布偏好的原因:一项混合方法访谈研究。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-06 DOI: 10.1016/j.jval.2026.07.005
Kyoko Shimamoto, Aki Tsuchiya
{"title":"Reasons for Distributional Preferences for Health Outcomes: A Mixed-Method Interview Study.","authors":"Kyoko Shimamoto, Aki Tsuchiya","doi":"10.1016/j.jval.2026.07.005","DOIUrl":"10.1016/j.jval.2026.07.005","url":null,"abstract":"<p><strong>Objectives: </strong>Policy makers need information on how members of the public value improving population health (efficiency) relative to reducing socioeconomic health inequality (equity). Quantitative evidence of the trade-off using benefit trade-off (BTO) is emerging, but not qualitative or mixed-method evidence. This mixed-method study aimed to elicit distributional preferences among the general population in Japan over socioeconomic inequality in lifetime health using BTO tasks and understand the underlying reasonings.</p><p><strong>Methods: </strong>Individual online interviews (n = 50) were conducted in 2022, comprising 2 main elements: (1) BTO tasks and (2) qualitative questions regarding the participant's understanding and reasonings behind their BTO task choices.</p><p><strong>Results: </strong>The median BTO response was inequality averse (prioritarian). The qualitative analysis found the relevance of nonhealth considerations such as prioritizing the health of the rich because they make more tax contributions, violating the symmetry assumption of the standard BTO, self-interested motivations despite the exercise using a social perspective, indecisive choices, and inconsistent reasonings across BTO subtasks.</p><p><strong>Conclusions: </strong>This is the first mixed-method interview study on BTO preferences of the public, involving an in-depth qualitative component. Some of the reasonings observed were similar to those in existing qualitative studies, albeit based on non-BTO methods. The findings also suggest heterogeneous reasonings by participant gender and geographic region. Some participants gave coherent explanations for behavior such as choosing a more unequal distribution in favor of the rich (\"inequality seeking\") or choosing a less unequal distribution even when nobody is better off (violation of monotonicity).</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148685802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Economic Evaluations of Hypertension Interventions in Pregnancy Lack Standardization: Results of a Systematic Review. 妊娠期高血压干预的经济评价缺乏标准化:一项系统评价的结果。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-06 DOI: 10.1016/j.jval.2026.06.025
Ling Jie Cheng, Lucy Abel, Svetlana Ratushnyak, Oliver Rivero-Arias, Richard J McManus, Lucy C Chappell, Helen E Campbell
{"title":"Economic Evaluations of Hypertension Interventions in Pregnancy Lack Standardization: Results of a Systematic Review.","authors":"Ling Jie Cheng, Lucy Abel, Svetlana Ratushnyak, Oliver Rivero-Arias, Richard J McManus, Lucy C Chappell, Helen E Campbell","doi":"10.1016/j.jval.2026.06.025","DOIUrl":"10.1016/j.jval.2026.06.025","url":null,"abstract":"<p><strong>Objectives: </strong>Hypertensive disorders of pregnancy (HDP), including preeclampsia, pose lifelong health risks for women and infants. Although HDP interventions are increasingly evaluated for cost-effectiveness, methodological challenges and heterogeneity between studies exist. This systematic review examines how economic evaluations have been conducted, focusing on methodology, outcome measurement, perspectives, time horizons, and cost-effectiveness conclusions.</p><p><strong>Methods: </strong>Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines, we searched MEDLINE, Embase, EconLit, and Web of Science from inception to December 31, 2024 for cost-effectiveness, cost-utility, cost-benefit, cost-consequence, and cost-minimization analyses of HDP interventions. Searching was updated on November 4, 2025. Data on costs, outcomes, and methodology were extracted. Reporting quality was evaluated using Consolidated Health Economic Evaluation Reporting Standards 2022.</p><p><strong>Results: </strong>Thirty-five included studies covered interventions from prevention to management. One-third of cost-effectiveness and cost-utility studies reported only women's outcomes. Among those capturing maternal and infant outcomes, more than half estimated cost-effectiveness using outcomes for only 1 party. The remainder generated results for mothers and infants but using different approaches. Long-term maternal cardiovascular risks and infant outcomes were rarely extrapolated. Most studies adopted healthcare perspectives. Screening, prevention, and diagnostic interventions were frequently cost-effective, whereas evidence for treatment and management strategies was mixed. Most studies reported cost per preeclampsia case averted; fewer applied generic measures, limiting comparability.</p><p><strong>Conclusions: </strong>Economic evaluations of HDP interventions face methodological challenges, particularly in capturing joint maternal and infant impacts. Furthermore, future studies should use adequate time horizons, wider perspectives, and generic health outcomes to ensure that cost-effectiveness evidence captures the full value of HDP interventions and informs policies optimizing maternal and neonatal health.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148685824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Psychometric Evaluation of Self- and Proxy-Reported EQ-5D-Y-3L and EQ-5D-Y-5L in Children With Attention-Deficit/Hyperactivity Disorder. 注意缺陷/多动障碍儿童自我和代理报告EQ-5D-Y-3L和EQ-5D-Y-5L的心理测量学评价
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-05 DOI: 10.1016/j.jval.2026.07.003
Richard Huan Xu, Chenxi Yang, Zhuxin Mao, Xiao Liang, Fanni Rencz
{"title":"Psychometric Evaluation of Self- and Proxy-Reported EQ-5D-Y-3L and EQ-5D-Y-5L in Children With Attention-Deficit/Hyperactivity Disorder.","authors":"Richard Huan Xu, Chenxi Yang, Zhuxin Mao, Xiao Liang, Fanni Rencz","doi":"10.1016/j.jval.2026.07.003","DOIUrl":"10.1016/j.jval.2026.07.003","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to assess the psychometric properties of 2 versions of EuroQol 5-Dimension Youth version (EQ-5D-Y) (3 level [Y-3L] and 5 level [Y-5L]) in children with attention-deficit/hyperactivity disorder (ADHD) and to compare their performance across self- and proxy-reported responses.</p><p><strong>Methods: </strong>Overall, 188 child-caregiver dyads (mean age 9 years with a clinical ADHD diagnosis) completed a cross-sectional survey, followed by a 2-week assessment to examine test-retest reliability. Outcome measures included the Y-3L and Y-5L, Child Health utility 9D, Child Behavior Checklist, and the Swanson, Nolan, and Pelham Rating Scale for ADHD severity. Ceiling, informativity, convergent and known-group validity, patient-proxy agreement, and test-retest reliability were assessed.</p><p><strong>Results: </strong>Self-reported Y-3L (48%) and Y-5L (28%) had higher ceilings than proxy versions (32% and 25%), and the Y-5L showed higher absolute informativity for both self- and proxy-reports. Self-reports correlated more strongly with the child-completed Child Health utility 9D, whereas proxy reports were more aligned with Child Behavior Checklist. Self-report version showed good known-groups validity: the Y-3L discriminated 11 of 14 groups, and the Y-5L discriminated 13 of 14. The proxy versions showed slightly weaker discrimination. Item-level test-retest reliability and patient-proxy agreement were good (Gwet's agreement coefficient [AC] 0.71-0.98 and 0.70-0.97), but scale-level reliability and agreement were lower.</p><p><strong>Conclusion: </strong>In Chinese children with ADHD, the Y-3L appears more suitable for self-report, whereas the Y-5L may be better for proxy report, depending on the population and study aims. Further research is needed to identify the optimal version across age groups and clinical conditions.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":" ","pages":""},"PeriodicalIF":6.2,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148679891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Informing the US Medicare Drug Price Negotiation for Trelegy Ellipta and Breo Ellipta: Evaluating the Impact of Real-World Evidence 通报Trelegy Ellipta和Breo Ellipta的美国医疗保险药品价格谈判:评估真实世界证据的影响。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-01 Epub Date: 2026-03-18 DOI: 10.1016/j.jval.2026.03.003
Marina Richardson PhD, Abigail C. Wright PhD, Shahariar Mohammed Fahim PhD, Jeffrey A. Tice MD, Kangho Suh PharmD, PhD, Josh J. Carlson PhD, David M. Rind MD
{"title":"Informing the US Medicare Drug Price Negotiation for Trelegy Ellipta and Breo Ellipta: Evaluating the Impact of Real-World Evidence","authors":"Marina Richardson PhD,&nbsp;Abigail C. Wright PhD,&nbsp;Shahariar Mohammed Fahim PhD,&nbsp;Jeffrey A. Tice MD,&nbsp;Kangho Suh PharmD, PhD,&nbsp;Josh J. Carlson PhD,&nbsp;David M. Rind MD","doi":"10.1016/j.jval.2026.03.003","DOIUrl":"10.1016/j.jval.2026.03.003","url":null,"abstract":"<div><h3>Objectives</h3><div>The Institute for Clinical and Economic Review (ICER) conducted a special assessment of Trelegy Ellipta and Breo Ellipta for chronic obstructive pulmonary disease to inform the Centers for Medicare and Medicaid Services (CMS) drug price negotiation process. In this manuscript, we examine the type, quality, and impact of the observational evidence included.</div></div><div><h3>Methods</h3><div>We described the type of observational evidence used in ICER’s assessment with a primary focus on adherence and persistence data. Risk of bias was assessed using the ROBINS-I.</div></div><div><h3>Results</h3><div>Observational data included in ICER’s review primarily informed the assessment of differential adherence and persistence between single and multiple inhaler products. The majority of studies were real-world evidence (RWE), utilizing claims or electronic health record data, and were deemed to be at moderate or severe risk of bias. RWE reported that Trelegy Ellipta and Breo Ellipta were associated with greater adherence and persistence compared with generic multiple-inhaler or multiple-daily-dosing alternatives. Persistence data were critical for differentiating between products in the cost-effectiveness analysis; however, persistence was based on prescription refills which is an imperfect measure of treatment continuation.</div></div><div><h3>Conclusions</h3><div>RWE played a critical role in evaluating the comparative clinical and cost-effectiveness of Trelegy Ellipta and Breo Ellipta to inform Centers for Medicare and Medicaid Services drug price negotiations. Differences in persistence informed differential pricing to generic multiple-inhaler or multiple-daily-dosing alternatives, demonstrating how data collected outside of clinical trials can inform value assessments. However, RWE limitations and the lack of evidence linking adherence or persistence to clinical outcomes highlight the need for future research.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 8","pages":"Pages 1360-1367"},"PeriodicalIF":6.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147491696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of the Medical Device Economic Evaluation Methodological Quality (DEEM-Q) Assessment Checklist 医疗器械经济评价方法质量(DEEM-Q)检查表的制定。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-01 Epub Date: 2026-03-18 DOI: 10.1016/j.jval.2026.03.002
Ilke Akpinar MD, Jeff Round PhD, Mike Paulden PhD
{"title":"Development of the Medical Device Economic Evaluation Methodological Quality (DEEM-Q) Assessment Checklist","authors":"Ilke Akpinar MD,&nbsp;Jeff Round PhD,&nbsp;Mike Paulden PhD","doi":"10.1016/j.jval.2026.03.002","DOIUrl":"10.1016/j.jval.2026.03.002","url":null,"abstract":"<div><h3>Objectives</h3><div>Economic evaluations increasingly inform adoption and reimbursement decisions for medical devices; yet, existing quality assessment tools were largely developed for pharmaceuticals and may not adequately capture device-specific methodological challenges. The objective of the medical Device Economic Evaluation Methodological Quality assessment study was to develop a consensus-based instrument for assessing the methodological quality of economic evaluations of medical devices.</div></div><div><h3>Methods</h3><div>Candidate items were identified through a systematic review of existing methodological quality assessment tools and economic evaluation guidelines, including those from Canada’s Drug Agency. A 2-round modified e-Delphi study was conducted with 40 health economists experienced in Canadian medical device evaluation (response rates: 100% and 90% for rounds 1 and 2, respectively). Using a 9-point importance scale, items were retained if ≥70% of participants rated them as critical (scores 7-9) and ≤15% rated them as not important (scores 1-3). The resulting checklist underwent pilot testing for clarity, applicability, and consistency.</div></div><div><h3>Results</h3><div>The initial 49 items were refined to 39, covering general economic evaluation domains (decision problem, comparators, perspective, time horizon, modeling, analysis, and uncertainty) and device-specific considerations (evidence gaps, learning curve, organizational impacts, incremental innovation, and diversity). Pilot testing confirmed clarity and consistent application.</div></div><div><h3>Conclusions</h3><div>The Device Economic Evaluation Methodological Quality assessment represents the first consensus-based checklist for assessing the methodological quality of medical device economic evaluations. It provides a practical tool for researchers, reviewers, and decision makers. A companion explanation and elaboration document has been developed to support consistent interpretation and application across decision contexts.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 8","pages":"Pages 1348-1359"},"PeriodicalIF":6.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147491660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retraction notice to Integrating Generative AI Into Evidence Synthesis: Opportunities, Safeguards, and Methodological Refinements 将生成式人工智能集成到证据合成中:机会,保障和方法改进的撤回通知:[JVAL vol . 29, June 2026, 4609]。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-01 Epub Date: 2026-07-30 DOI: 10.1016/j.jval.2026.06.008
Weihao Cheng BEng, Hangyu Zhu BEng, Yuanyuan Lian BEng
{"title":"Retraction notice to Integrating Generative AI Into Evidence Synthesis: Opportunities, Safeguards, and Methodological Refinements","authors":"Weihao Cheng BEng,&nbsp;Hangyu Zhu BEng,&nbsp;Yuanyuan Lian BEng","doi":"10.1016/j.jval.2026.06.008","DOIUrl":"10.1016/j.jval.2026.06.008","url":null,"abstract":"<div><div>This article has been retracted: please see Elsevier Policy on Article Withdrawal (<span><span>https://www.elsevier.com/about/policies/article-withdrawal</span><svg><path></path></svg></span>).</div><div>This letter has been retracted at the request of the Editors-in-Chief.</div><div>The undisclosed use of artificial intelligence in the preparation of this work represents a clear violation of the journal’s editorial policies and publishing ethics standards.</div><div>Apologies to the readers of the journal that this was not detected during the submission process.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 8","pages":"Page 1537"},"PeriodicalIF":6.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148631606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bayesian Indirect Comparison and Cost-Effectiveness of Sacituzumab Govitecan Versus Sacituzumab Tirumotecan in Metastatic Triple-Negative Breast Cancer Sacituzumab Govitecan与Sacituzumab替鲁莫替康治疗转移性三阴性乳腺癌的贝叶斯间接比较和成本-效果
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-01 Epub Date: 2026-02-24 DOI: 10.1016/j.jval.2026.02.004
Yamin Shu MSc, Ying Tang MD, Yiling Ding PhD, Wenting Zhang MD, Qilin Zhang MD
{"title":"Bayesian Indirect Comparison and Cost-Effectiveness of Sacituzumab Govitecan Versus Sacituzumab Tirumotecan in Metastatic Triple-Negative Breast Cancer","authors":"Yamin Shu MSc,&nbsp;Ying Tang MD,&nbsp;Yiling Ding PhD,&nbsp;Wenting Zhang MD,&nbsp;Qilin Zhang MD","doi":"10.1016/j.jval.2026.02.004","DOIUrl":"10.1016/j.jval.2026.02.004","url":null,"abstract":"<div><h3>Objectives</h3><div>Sacituzumab govitecan (SG) and sacituzumab tirumotecan (sac-TMT) are 2 approved antibody-drug conjugates for metastatic triple-negative breast cancer but lack direct comparison. Given their similar indications and high costs, an indirect cost-effectiveness analysis is essential to inform pricing and reimbursement decisions from the perspective of the Chinese healthcare system.</div></div><div><h3>Methods</h3><div>A partitioned survival model using Bayesian network meta-analysis and flexible parametric modeling estimated long-term survival, quality-adjusted life-years (QALYs), and costs. Participants were derived from the ASCENT and OptiTROP-Breast01 randomized controlled trials. Key outcomes included time-varying hazard ratio, life-years, costs, incremental cost-effectiveness ratio (ICER), incremental net health benefit, and incremental net monetary benefit. Multiple sensitivity and scenario analyses tested model robustness.</div></div><div><h3>Results</h3><div>In the base-case analysis, SG yielded 0.095 additional QALYs compared with sac-TMT at an incremental cost of $68 266, resulting in an ICER of $719 726 per QALY and an incremental net monetary benefit of −$64 400. Sensitivity analyses identified SG price and model time horizon as key drivers of ICER. In all plausible scenarios, SG remained not cost-effective versus sac-TMT. Probabilistic results showed a 0% probability of cost-effectiveness at a willingness-to-pay threshold of $40 763 per QALY. Scenario analysis confirmed the robustness of findings across assumptions on time horizon, utility, wastage, and discounting.</div></div><div><h3>Conclusions</h3><div>SG showed slightly greater health gains but much higher costs than sac-TMT, leading to poor cost-effectiveness at current prices. Given the high substitutability between antibody-drug conjugates in metastatic triple-negative breast cancer, indirect comparisons with economic modeling can help guide payer decisions and pricing negotiations when head-to-head data are lacking.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 8","pages":"Pages 1385-1394"},"PeriodicalIF":6.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147310618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Valuation of EQ-5D-5L With 2 Bolt-On Items: Further Evaluation of the Scaling Factor Model 用两个附加项评价EQ-5D-5L:比例因子模型的进一步评价。
IF 6.2 2区 医学
Value in Health Pub Date : 2026-08-01 Epub Date: 2026-03-10 DOI: 10.1016/j.jval.2026.02.012
Zhihao Yang PhD, Kim Rand PhD, Aureliano Finch PhD, Nan Luo PhD
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