法国对已切除食管癌或胃食管交界癌患者进行 Nivolumab 辅助治疗的成本效益分析。

IF 2 Q2 ECONOMICS
PharmacoEconomics Open Pub Date : 2024-09-01 Epub Date: 2024-07-04 DOI:10.1007/s41669-024-00500-y
Paul Casabianca, Marc Massetti, François-Emery Cotte, Romain Moreau, Sarah Kassahun, Prianka Singh, Inkyu Kim, Anne-Françoise Gaudin, Guillaume Piessen, Henri Leleu
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引用次数: 0

摘要

导言:食管癌和胃食管交界癌(EC/GEJC)是一种预后不良的疾病,即使是治愈性切除的患者也有很高的复发风险。目前,尼妥珠单抗辅助治疗适用于完全切除(R0)的EC/GEJC患者,这些患者在接受新辅助化放疗后仍有病理残留。本研究旨在根据集体视角(不包括间接成本)确定 nivolumab 在法国该适应症中的成本效益:建立了一个简化的四健康状态半马尔可夫模型,以模拟在新辅助化放疗后R0的EC/GEJC患者在15年时间内的残留疾病情况,比较了辅助尼夫单抗与监测(免疫疗法到来之前法国推荐的临床实践)。来自CheckMate 577的复发时间(TTR)用于告知从无病到复发后健康状态的转变;复发患者根据试验期间观察到的复发类型分布进行划分。根据复发类型得出的复发后生存率(PRS)来自真实世界登记:结果:使用 nivolumab 进行辅助治疗可获得 1.19 年的增量生存期(+ 34%),其中大部分为无病生存期,增量成本为 48,634 欧元,QALY 为 0.98,因此增量成本效用比 (ICUR) 为 49,572 欧元/QALY,不确定性有限。5 年的 "治愈假设 "对结果产生了重要影响(41115 欧元/QALY;- 17%),因为这往往会增加生命年数和 QALY,而成本保持不变。概率敏感性分析证实了参考ICUR(52,542欧元/QALY),在75,000欧元/QALY的支付意愿阈值下,nivolumab具有成本效益的概率为80%:我们的分析表明,对于在新辅助CRT治疗后进行R0切除术并有残留疾病的EC/GEJC患者,nivolumab辅助治疗具有成本效益。与之前对其他用于转移性治疗的免疫检查点抑制剂进行的成本效益分析相比,ICUR在这种早期治疗中显得特别低,这要归功于其对健康结果的重要影响以及治疗时间的上限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Cost-Effectiveness Analysis of Adjuvant Nivolumab for Patients with Resected Esophageal Cancer or Gastroesophageal Junction Cancer in France.

Introduction: Esophageal and gastroesophageal junction cancer (EC/GEJC) is a poor prognosis disease with a high risk of recurrence even in patients curatively resected. Adjuvant nivolumab is currently used for patients with completely resected (R0) EC/GEJC who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. This study aimed to determine the cost effectiveness of nivolumab in this indication in France according to the collective perspective excluding indirect costs.

Materials and methods: A simplified four-health-state semi-Markov model was developed to model EC/GEJC patients who have residual disease after neoadjuvant chemoradiotherapy followed by R0 over a 15-year time horizon, comparing adjuvant nivolumab versus surveillance, which was the recommended French clinical practice before immunotherapy arrival. Time-to-recurrence (TTR) from CheckMate 577 was used to inform transition from disease-free to post-recurrence health state; patients who recurred were split according to the distribution of type of recurrence observed during the trial. Post-recurrence survival (PRS) according to the type of recurrence was derived from a real-world registry.

Results: Adjuvant treatment with nivolumab led to an incremental survival gain of 1.19 years (+ 34%), mostly in the disease-free state, an incremental cost of €48,634 and QALY of 0.98 resulting in an incremental cost-utility ratio (ICUR) of €49,572/QALY with limited uncertainty. 'Cure assumption' at 5 years had an important impact on the results (€41,115/QALY; - 17%), as that tends to increase life-years and QALYs while costs remain the same. Probabilistic sensitivity analyses confirmed reference ICUR (€52,542/QALY) with 80% probability of nivolumab being cost effective at a willingness-to-pay threshold of €75,000/QALY.

Conclusions: Our analysis suggests that adjuvant nivolumab is cost effective in the treatment of EC/GEJC patients who have residual disease after neoadjuvant CRT followed by R0 resection. Compared with previously evaluated cost-effectiveness analyses for other immune-checkpoint inhibitors indicated in metastatic settings, ICUR appears particularly low in this early setting thanks to the important impact on health outcomes and capped treatment duration.

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来源期刊
CiteScore
3.50
自引率
0.00%
发文量
64
审稿时长
8 weeks
期刊介绍: PharmacoEconomics - Open focuses on applied research on the economic implications and health outcomes associated with drugs, devices and other healthcare interventions. The journal includes, but is not limited to, the following research areas:Economic analysis of healthcare interventionsHealth outcomes researchCost-of-illness studiesQuality-of-life studiesAdditional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in PharmacoEconomics -Open may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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