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在美国,帕尼单抗与贝伐单抗用于野生型RAS转移性结直肠癌患者一线治疗的试验内成本效益分析。

A within-trial cost-effectiveness analysis of panitumumab compared with bevacizumab in the first-line treatment of patients with wild-type RAS metastatic colorectal cancer in the US.

作者信息

Graham Christopher N, Christodoulopoulou Alexandra, Knox Hediyyih N, Sabatelli Lorenzo, Hechmati Guy, Garawin Tamer, Strickler John H

机构信息

a RTI Health Solutions, Research Triangle Park , NC , USA.

b Amgen Inc. , Thousand Oaks , CA , USA.

出版信息

J Med Econ. 2018 Nov;21(11):1075-1083. doi: 10.1080/13696998.2018.1510409. Epub 2018 Sep 28.

Abstract

AIMS

This analysis investigated the cost-effectiveness of panitumumab plus mFOLFOX6 (oxaliplatin, 5-fluorouracil, and leucovorin) compared with bevacizumab plus mFOLFOX6 in the first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC).

MATERIALS AND METHODS

The cost-effectiveness analysis was developed from a third-party payer perspective in the US and was implemented using a partitioned survival model with health states for first-line treatment (progression-free), disease progression with and without subsequent active treatment, and death. Survival analyses of patients with wild-type RAS mCRC from the PEAK head-to-head clinical trial of panitumumab vs bevacizumab were performed to estimate time in the model health states. Additional data from PEAK informed the amount of each drug consumed, duration of therapy, subsequent therapy use, and toxicities related to mCRC treatment. Literature and US public data sources were used to estimate unit costs associated with treatment and duration of subsequent active therapies. Utility weights were calculated from patient-level data from panitumumab trials in the first-, second-, and third-line settings. A life-time perspective was taken with future costs and outcomes discounted at 3% per annum. Scenario, one-way, and probabilistic sensitivity analyses were performed.

RESULTS

Compared with bevacizumab, the use of panitumumab resulted in an incremental cost of US $60,286, and an incremental quality-adjusted life-year (QALY) of 0.445, translating into a cost per QALY gained of US $135,391 in favor of panitumumab. Results were sensitive to wastage and dose rounding assumptions modeled.

LIMITATIONS

Progression-free and overall survival were extrapolated beyond the follow-up of the primary analysis using fitted parametric curves. Costs and quality of life were estimated from multiple and different data sources.

CONCLUSIONS

The efficacy of panitumumab in extending progression-free and overall survival and improving quality of life makes it a cost-effective option for first-line treatment of patients with wild-type RAS mCRC compared with bevacizumab.

摘要

目的

本分析研究了帕尼单抗联合mFOLFOX6(奥沙利铂、5-氟尿嘧啶和亚叶酸钙)与贝伐单抗联合mFOLFOX6相比,在野生型RAS转移性结直肠癌(mCRC)患者一线治疗中的成本效益。

材料与方法

成本效益分析是从美国第三方支付方的角度开展的,并使用了一个分区生存模型,该模型具有一线治疗(无进展)、疾病进展(有后续积极治疗和无后续积极治疗)以及死亡等健康状态。对帕尼单抗与贝伐单抗的PEAK头对头临床试验中野生型RAS mCRC患者进行生存分析,以估计模型健康状态下的时间。PEAK的其他数据为每种药物的消耗量、治疗持续时间、后续治疗使用情况以及与mCRC治疗相关的毒性提供了信息。利用文献和美国公共数据源来估计与治疗及后续积极治疗持续时间相关的单位成本。效用权重是根据帕尼单抗在一线、二线和三线治疗试验中的患者层面数据计算得出的。采用终身视角,未来成本和结果按每年3%进行贴现。进行了情景分析、单因素敏感性分析和概率敏感性分析。

结果

与贝伐单抗相比,使用帕尼单抗导致成本增加60,286美元,质量调整生命年(QALY)增加0.445,这意味着每获得一个QALY的成本为135,391美元,支持使用帕尼单抗。结果对所模拟的浪费和剂量舍入假设敏感。

局限性

无进展生存期和总生存期是使用拟合参数曲线在主要分析随访期之外进行外推的。成本和生活质量是根据多个不同数据源估计的。

结论

与贝伐单抗相比,帕尼单抗在延长无进展生存期和总生存期以及改善生活质量方面的疗效使其成为野生型RAS mCRC患者一线治疗的一个具有成本效益的选择。

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