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免疫检查点抑制剂和靶向治疗进展后晚期黑色素瘤患者中 lifileucel 的成本-效用:中等收入经济体背景

英文原题:Cost-utility of lifileucel in patients with advanced melanoma after progression on immune checkpoint inhibitors And targeted therapies: a middle-income economy setting.

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Cost-utility of lifileucel in patients with advanced melanoma after progression on immune checkpoint inhibitors And targeted therapies: a middle-income economy setting.

PubMed 2025/07/18(内容时间) Br J Clin Pharmacol Q2 · IF 3(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究概要

使用 TIL(lifileucel)治疗难治性晚期黑色素瘤目前在小型、中等收入经济体中不具备成本效益,并且在不久的将来也不太可能具备成本效益。

研究思路结论见上方概要

自体TIL(肿瘤浸润淋巴细胞)疗法用于治疗耐药性晚期黑色素瘤近期已获得上市许可。本研究旨在比较TIL疗法用于转移性或不可切除恶性黑色素瘤与当前治疗方案的成本效益,当前治疗方案包括化疗以及涉及B-Raf抑制剂、丝裂原活化蛋白激酶抑制剂和PD-1阻断剂的三联疗法。

本研究采用建模方法,包括构建和模拟分区生存模型。目标人群为黑山共和国(一个中等收入小型经济体)的难治性晚期黑色素瘤患者。

研究表明,与化疗或三联疗法相比,使用源自黑色素瘤浸润组织的修饰淋巴细胞(lifileucel)进行一次性治疗,对于靶向治疗和免疫治疗耐药的晚期黑色素瘤而言,并非一种具有成本效益的治疗选择。增量净货币效益分别为-417 270.26 3748.33 EUR和-368 813.66 4220.11 EUR。增量成本效果比分别为550 276.80 1 134 093.26 EUR(95%置信区间)和675 364.93 1 181 289.48 EUR(95%置信区间),远高于黑山最高可接受的成本效果阈值86 382.00 EUR每质量调整生命年。敏感性分析未改变这一结论,涉及每组75-100名患者的临床或前瞻性队列研究可明确证实这一点,需要投资4500-5000万欧元。

展开英文摘要原文

This study used a modelling approach that involved the construction and simulation of a partitioned survival model. The target population consisted of patients with treatment-resistant advanced melanoma in Montenegro, a small, middle-income economy.

The study showed that a 1-time therapy with modified lymphocytes derived from the melanoma-infiltrated tissue (lifileucel) is not a cost-effective treatment option for advanced melanoma resistant to targeted and immunotherapy when compared to chemotherapy or triple therapy. The incremental net monetary benefit was -417 270.26 3748.33 EUR and -368 813.66 4220.11 EUR, respectively. The incremental cost-effectiveness ratio was 550 276.80 1 134 093.26 EUR (95% confidence interval) and 675 364.93 1 181 289.48 EUR (95% confidence interval), respectively, which is much above the highest acceptable cost-effectiveness threshold for Montenegro of 86 382.00 EUR per quality-adjusted life year. The sensitivity analysis did not alter this conclusion, which could be clearly confirmed by clinical or prospective cohort studies involving 75-100 patients per arm, requiring an investment of 45-50 million euros.

The treatment of therapy-resistant advanced melanoma using TILs (lifileucel) is currently not cost-effective in small, middle-income economies and is unlikely to become so in the near future.

论文信息

作者
Obrenovic S、Folic MM、Folic ND、Jankovic SM
第一作者单位
Faculty of Medicine, University of Montenegro, Podgorica, Montenegro.
通讯作者单位
Faculty of Medical Science, University of Kragujevac, Kragujevac, Serbia.
期刊
British journal of clinical pharmacology2025 Jul 18
原文标识
PubMed 40678924 · DOI 10.1002/bcp.70172