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法国局部晚期或转移性尿路上皮癌成人患者一线维持治疗avelumab 的成本效益分析。

Cost-effectiveness of avelumab first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma in France.

机构信息

Health Economics Department, Merck Santé S.A.S., Lyon, France.

Health Economics department, Pfizer S.A.S., Paris, France.

出版信息

PLoS One. 2024 May 10;19(5):e0302548. doi: 10.1371/journal.pone.0302548. eCollection 2024.

Abstract

BACKGROUND

This study evaluated the cost-effectiveness of avelumab first-line (1L) maintenance therapy plus best supportive care (BSC) versus BSC alone for adults with locally advanced or metastatic urothelial carcinoma (la/mUC) that had not progressed following platinum-based chemotherapy in France.

METHODS

A three-state partitioned survival model was developed to assess the lifetime costs and effects of avelumab plus BSC versus BSC alone. Data from the phase 3 JAVELIN Bladder 100 trial (NCT02603432) were used to inform estimates of clinical and utility values considering a 10-year time horizon and a weekly cycle length. Cost data were estimated from a collective perspective and included treatment acquisition, administration, follow-up, adverse event-related hospitalization, transport, post-progression, and end-of-life costs. Health outcomes were measured in quality-adjusted life-years (QALYs) and life-years gained. Costs and clinical outcomes were discounted at 2.5% per annum. Incremental cost-effectiveness ratios (ICERs) were used to compare cost-effectiveness and willingness to pay in France. Uncertainty was assessed using a range of sensitivity analyses.

RESULTS

Avelumab plus BSC was associated with a gain of 2.49 QALYs and total discounted costs of €136,917; BSC alone was associated with 1.82 QALYs and €39,751. Although avelumab plus BSC was associated with increased acquisition costs compared with BSC alone, offsets of -€20,424 and -€351 were observed for post-progression and end-of-life costs, respectively. The base case analysis ICER was €145,626/QALY. Sensitivity analyses were consistent with the reference case and showed that efficacy parameters (overall survival, time to treatment discontinuation), post-progression time on immunotherapy, and post-progression costs had the largest impact on the ICER.

CONCLUSIONS

This analysis demonstrated that avelumab plus BSC is associated with a favorable cost-effectiveness profile for patients with la/mUC who are eligible for 1L maintenance therapy in France.

摘要

背景

本研究评估了avelumab 一线(1L)维持治疗联合最佳支持治疗(BSC)对比 BSC 单药治疗在法国局部晚期或转移性尿路上皮癌(la/mUC)患者中的成本效益,这些患者在铂类化疗后未进展。

方法

采用三状态分区生存模型评估avelumab 联合 BSC 对比 BSC 单药治疗的终生成本和效果。采用 III 期 JAVELIN Bladder 100 试验(NCT02603432)的数据来评估考虑 10 年时间范围和每周周期长度的临床和效用值。从总体角度估计成本数据,包括治疗获得、管理、随访、与不良事件相关的住院、交通、进展后和生命终末期成本。健康结果以质量调整生命年(QALY)和生命年数表示。成本和临床结果按每年 2.5%贴现。增量成本效益比(ICER)用于比较法国的成本效益和支付意愿。采用一系列敏感性分析评估不确定性。

结果

avelumab 联合 BSC 治疗可获得 2.49 个 QALY 和 136917 欧元的总折扣成本;BSC 单药治疗可获得 1.82 个 QALY 和 39751 欧元。与 BSC 单药治疗相比,avelumab 联合 BSC 治疗的获得成本增加,但观察到进展后和生命终末期成本分别为-20424 欧元和-351 欧元的抵消。基本情况分析的 ICER 为 145626 欧元/QALY。敏感性分析与参考情况一致,表明疗效参数(总生存、治疗停止时间)、免疫治疗后进展时间和进展后成本对 ICER 的影响最大。

结论

本分析表明,对于有资格接受 1L 维持治疗的法国局部晚期或转移性尿路上皮癌患者,avelumab 联合 BSC 具有良好的成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40a7/11086848/a983e6fcde44/pone.0302548.g001.jpg

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