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奥马珠单抗治疗慢性自发性荨麻疹的成本效益分析。

Cost-effectiveness of omalizumab for the treatment of chronic spontaneous urticaria.

机构信息

Institute for Medical Technology Assessment, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, the Netherlands.

Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands.

出版信息

Br J Dermatol. 2018 Sep;179(3):702-708. doi: 10.1111/bjd.16476. Epub 2018 Jun 15.

Abstract

BACKGROUND

Chronic spontaneous urticaria (CSU) is a skin disease with itchy hives and/or angio-oedema that last for at least 6 weeks without an obvious external trigger.

OBJECTIVES

To determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to four times the daily dose of H -antihistamines) in the Netherlands from a societal perspective.

METHODS

The Markov model used consisted of five health states based on Urticaria Activity Score over 7 days. Model settings and characteristics of the Dutch patient population were based on an online survey among clinical experts and were validated during an expert committee meeting. Transition probabilities were derived from the GLACIAL trial. Healthcare consumption, quality of life (using EuroQol-5D) and productivity losses were derived from a burden-of-illness study (ASSURE-CSU) among 93 Dutch patients. Healthcare consumption and productivity losses were evaluated using the Dutch costing manual. The comparator treatment was SoC, consisting of (updosed) antihistamines. A 10-year time horizon was used.

RESULTS

The incremental cost-effectiveness ratio (ICER) of omalizumab vs. SoC was €17 502 per quality-adjusted life-year (QALY) gained. Productivity costs played an important role in the value of the ICER; discarding productivity costs resulted in an ICER of €85 310 per QALY.

CONCLUSIONS

Omalizumab is cost-effective compared with SoC. The outcomes of this study were used to establish omalizumab as third-line therapy in the Dutch treatment guidelines for CSU.

摘要

背景

慢性自发性荨麻疹(CSU)是一种皮肤疾病,其特征为瘙痒性风团和/或血管性水肿,持续至少 6 周,且无明显外部诱因。

目的

从社会角度出发,确定奥马珠单抗相对于标准护理(SoC;H1 抗组胺药的日剂量增加 4 倍)在荷兰的成本效益。

方法

所使用的 Markov 模型由基于 7 天内荨麻疹活动评分的五个健康状态组成。模型设置和荷兰患者人群的特征基于对临床专家的在线调查,并在专家委员会会议期间进行了验证。转移概率来自 GLACIAL 试验。医疗保健消费、生活质量(使用 EuroQol-5D)和生产力损失来自 93 名荷兰患者的疾病负担研究(ASSURE-CSU)。医疗保健消费和生产力损失使用荷兰成本手册进行评估。对照治疗是 SoC,包括(加量)抗组胺药。使用了 10 年的时间范围。

结果

奥马珠单抗与 SoC 相比的增量成本效益比(ICER)为每获得一个质量调整生命年(QALY)增加 17502 欧元。生产力成本在 ICER 的价值中起着重要作用;丢弃生产力成本会导致每获得一个 QALY 的 ICER 为 85310 欧元。

结论

奥马珠单抗与 SoC 相比具有成本效益。本研究的结果被用于将奥马珠单抗确立为荷兰 CSU 治疗指南中的三线治疗药物。

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