治疗转移性三阴性乳腺癌的sacituzumab govitecan与单药化疗的成本效益:基于试验的分析。

IF 1.7 4区 医学 Q3 HEALTH POLICY & SERVICES Cost Effectiveness and Resource Allocation Pub Date : 2024-04-24 DOI:10.1186/s12962-024-00539-y
Yilai Wu, Shanshan Hu, Xiaolin Liu, Yang Chen, Jiajie Luan, Shuowen Wang
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引用次数: 0

摘要

研究背景萨妥珠单抗戈维替康(SG)最近在中国获批用于转移性三阴性乳腺癌(mTNBC)的线后治疗。与单药化疗相比,SG可大幅提高预处理mTNBC的无进展生存期和总生存期。然而,鉴于 SG 的价格昂贵,有必要从成本和疗效的角度考虑其价值。本研究旨在从中国医疗系统的角度,估算SG与医生自选单药治疗(TPC)在mTNBC患者后线治疗中的成本效益:队列特征来自ASCENT随机临床试验,该试验于2017年11月至2019年9月期间招募了468名重度预处理mTNBC患者。构建了一个分区生存模型,以评估SG与TPC在mTNBC后线治疗中的长期成本和有效性。质量调整生命月(QALMs)和总成本(以2022年美元计算)用于得出增量成本效益比(ICER)。质量调整生命月和成本的贴现率为每年 5%。支付意愿(WTP)阈值定义为每 QALM 3188 美元,即 2022 年中国月人均国内生产总值的三倍。为估计结果的稳健性,进行了单向敏感性分析、概率敏感性分析和情景分析:结果:使用 SG 治疗可增加 5.17 个 QALM,每个 QALM 的成本为 44,792 美元,远高于中国 3188 美元/QALM 的 WTP 临界值。单向敏感性分析表明,SG 价格是影响 ICER 的关键因素。概率敏感性分析表明,在当前环境下,SG 的成本效益可接受性为 0%。情景分析表明,这一结果在 ASCENT 的所有分组或不同时间跨度下都是稳健的。此外,SG 必须降价才能进入中国大陆市场。当 SG 的每月费用降低到 2298 美元时,SG 成为 TPC 首选的可能性约为 50%:结论:以香港目前的价格(每 QALM 3188 美元的 WTP 临界值)估算,与 TPC 相比,SG 用于中国 mTNBC 后线治疗的成本效益不高。有必要大幅降价以提高其成本效益。
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Cost-effectiveness of sacituzumab govitecan versus single-agent chemotherapy for metastatic triple-negative breast cancer: a trial-based analysis.

Background: Sacituzumab govitecan (SG) has recently been approved in China for the post-line treatment of metastatic triple-negative breast cancer (mTNBC). SG substantially improves progression-free survival and overall survival compared with single-agent chemotherapy for pretreated mTNBC. However, in view of the high price of SG, it is necessary to consider its value in terms of costs and outcomes. This study aimed to estimate the cost-effectiveness of SG versus single-agent treatment of physician's choice (TPC) in the post-line setting for patients with mTNBC from a Chinese healthcare system perspective.

Methods: The cohort characteristics were sourced from the ASCENT randomized clinical trial, which enrolled 468 heavily pretreated patients with mTNBC between November 2017 and September 2019. A partitioned survival model was constructed to assess the long-term costs and effectiveness of SG versus TPC in the post-line treatment of mTNBC. Quality-adjusted life-months (QALMs) and total costs in 2022 US dollars were used to derive incremental cost effectiveness ratio (ICER). QALMs and costs were discounted at 5% annually. The willingness-to-pay (WTP) threshold was defined as $3188 per QALM, three times China's average monthly per capita gross domestic product in 2022. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analyses were performed to estimate the robustness of the results.

Results: Treatment with SG yielded an incremental 5.17 QALMs at a cost of $44,792 per QALM, much above the WTP threshold of $3188/QALM in China. One-way sensitivity analysis showed that SG price was a crucial factor in the ICER. Probabilistic sensitivity analysis revealed that the cost-effective acceptability of SG was 0% in the current setting. Scenario analyses indicated that the result was robust in all subgroups in ASCENT or under different time horizons. Furthermore, SG must reduce the price to enter the Chinese mainland market. When the monthly cost of SG reduce to $2298, SG has about 50% probability to be a preferred choice than TPC.

Conclusions: SG was estimated to be not cost-effective compared with TPC for post-line treatment for mTNBC in China by the current price in HK under a WTP threshold of $3188 per QALM. A drastic price reduction is necessary to improve its cost-effectiveness.

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来源期刊
Cost Effectiveness and Resource Allocation
Cost Effectiveness and Resource Allocation HEALTH POLICY & SERVICES-
CiteScore
3.40
自引率
4.30%
发文量
59
审稿时长
34 weeks
期刊介绍: Cost Effectiveness and Resource Allocation is an Open Access, peer-reviewed, online journal that considers manuscripts on all aspects of cost-effectiveness analysis, including conceptual or methodological work, economic evaluations, and policy analysis related to resource allocation at a national or international level. Cost Effectiveness and Resource Allocation is aimed at health economists, health services researchers, and policy-makers with an interest in enhancing the flow and transfer of knowledge relating to efficiency in the health sector. Manuscripts are encouraged from researchers based in low- and middle-income countries, with a view to increasing the international economic evidence base for health.
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