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曲妥珠单抗-德鲁替康二线治疗芬兰不可切除和/或转移性 HER2 阳性乳腺癌的成本效果模型。

Cost-effectiveness model of trastuzumab deruxtecan as second-line treatment in HER2-positive unresectable and/or metastatic breast cancer in Finland.

机构信息

Department of Health Sciences, University Medical Center Groningen, Groningen, The Netherlands.

Asc Academics, Groningen, The Netherlands.

出版信息

Eur J Health Econ. 2024 Jun;25(4):689-699. doi: 10.1007/s10198-023-01617-3. Epub 2023 Jul 24.

DOI:10.1007/s10198-023-01617-3
PMID:37486557
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11136791/
Abstract

OBJECTIVES

Trastuzumab deruxtecan (T-DXd) was recently recommended by the Committee for Medicinal Products for Human Use as a treatment for adult patients with unresectable or metastatic HER2-positive breast cancer, who had received a prior anti-HER2-based regimen. In our study, we evaluated the cost-effectiveness of T-DXd compared with ado-trastuzumab emtansine (T-DM1) for this indication in Finland.

METHODS

A three-state partitioned survival analysis model was developed with a payer's perspective. Time to event data from the DESTINY-Breast03 (DB-03) trial were extrapolated over a lifetime horizon either directly-for progression-free survival and time to treatment discontinuation-or using an alternative approach utilizing long-term T-DM1 survival data and DB-03 data-for overall survival. Discount rates of 3% were applied for costs and effects. Inputs were sourced from the Medicinal Products Database from Kela, Helsinki University Hospital service price list, Finnish Medicines Agency assessments, clinical experts, and DB-03. Sensitivity analyses were performed to characterize and demonstrate parameter uncertainties in the model.

RESULTS

Total quality-adjusted life years (QALYs) and life years (LYs) gained for T-DXd compared with T-DM1 were 1.93 and 2.56, respectively. Incremental costs for T-DXd compared with T-DM1 were €106,800, resulting in an ICER of €55,360 per QALY gained and an ICER of €41,775 per LY gained. One-way sensitivity analysis showed the hazard ratio of T-DXd vs T-DM1 for OS was the most influential parameter. The probabilistic sensitivity analysis showed similar results to the base case.

CONCLUSIONS

T-DXd is cost-effective based on surrogate WTP thresholds of €72,000 and €139,000 per QALY.

摘要

目的

曲妥珠单抗-德鲁替康(T-DXd)最近被人用药品委员会推荐用于治疗不可切除或转移性 HER2 阳性乳腺癌的成人患者,这些患者之前接受过基于抗 HER2 的治疗方案。在我们的研究中,我们评估了 T-DXd 相对于 ado-曲妥珠单抗-美坦新偶联物(T-DM1)在芬兰该适应症下的成本效益。

方法

采用支付者视角,建立了三状态分区生存分析模型。来自 DESTINY-Breast03(DB-03)试验的生存数据,直接用于无进展生存期和治疗中断时间,或者采用替代方法,利用长期 T-DM1 生存数据和 DB-03 数据,用于总生存期。对成本和效果采用 3%的贴现率。投入来源于 Kela 的药品数据库、赫尔辛基大学医院服务价格清单、芬兰药品管理局评估、临床专家和 DB-03。进行敏感性分析以描述和展示模型中的参数不确定性。

结果

与 T-DM1 相比,T-DXd 获得的总质量调整生命年(QALY)和生命年(LY)分别为 1.93 和 2.56。与 T-DM1 相比,T-DXd 的增量成本为 106800 欧元,导致每获得一个 QALY 的增量成本效益比为 55360 欧元,每获得一个 LY 的增量成本效益比为 41775 欧元。单因素敏感性分析表明,T-DXd 与 T-DM1 相比的 OS 风险比是最具影响力的参数。概率敏感性分析显示与基本情况相似的结果。

结论

根据每 QALY 72000 欧元和每 LY 139000 欧元的替代意愿支付阈值,T-DXd 具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/139bd975883f/10198_2023_1617_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/cea232b825f4/10198_2023_1617_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/fa7ded423d21/10198_2023_1617_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/d4ddea9342dd/10198_2023_1617_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/139bd975883f/10198_2023_1617_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/cea232b825f4/10198_2023_1617_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/fa7ded423d21/10198_2023_1617_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/d4ddea9342dd/10198_2023_1617_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4622/11136791/139bd975883f/10198_2023_1617_Fig4_HTML.jpg

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