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西米普利单抗作为复发性宫颈癌患者的二线治疗:一项基于美国的成本效益分析。

Cemiplimab as Second-Line Therapy for Patients with Recurrent Cervical Cancer: A United States-based Cost-effectiveness Analysis.

作者信息

Liu Kun, Zhu Youwen, Zhou Yangying, Zhu Hong

机构信息

Department of Oncology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.

National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.

出版信息

Adv Ther. 2023 Apr;40(4):1838-1849. doi: 10.1007/s12325-023-02472-7. Epub 2023 Mar 4.

Abstract

INTRODUCTION

The efficacy of cemiplimab in recurrent cervical cancer has been demonstrated in the clinical trial EMPOWER-Cervical 1. However, its high price makes patients and clinicians hesitate to use it. Therefore, we designed a study to evaluate its cost-effectiveness.

METHODS

We developed a Markov model based on phase III clinical trials to calculate the cost, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) over 20 years with a willingness-to-pay (WTP) threshold of $150,000/QALY. The economic data included were obtained from official US government websites and published literature. Sensitivity analysis was used to determine the uncertainties associated with the model, and a subgroup analysis was performed.

RESULTS

Compared with chemotherapy, cemiplimab produced an additional 0.597 QALYs (0.751 LYs), resulting in an ICER of $111,211.471/QALY in the United States. The cost of cemiplimab is the most influential factor in the model. The results of these models were robust in all sensitivity analyses. From the American public payers' perspective, subgroup analysis showed cemiplimab was a cost-effective regimen in patients with squamous cell carcinoma, adenocarcinoma, or programmed cell death ligand 1 (PD-L1) ≥ 1%.

CONCLUSION

From the American public payers' perspective, cemiplimab is a cost-effective treatment option for second-line treatment of recurrent cervical cancer. Meanwhile, cemiplimab was a cost-effective treatment for patients with PD-L1 ≥ 1 and all histological types.

摘要

引言

西米普利单抗在复发性宫颈癌中的疗效已在临床试验EMPOWER-Cervical 1中得到证实。然而,其高昂的价格让患者和临床医生在使用时有所顾虑。因此,我们设计了一项研究来评估其成本效益。

方法

我们基于III期临床试验开发了一个马尔可夫模型,以计算20年内的成本、生命年(LYs)、质量调整生命年(QALYs)和增量成本效益比(ICER),支付意愿(WTP)阈值为150,000美元/QALY。所纳入的经济数据来自美国政府官方网站和已发表的文献。采用敏感性分析来确定与模型相关的不确定性,并进行亚组分析。

结果

与化疗相比,西米普利单抗额外产生了0.597个QALYs(0.751个LYs),在美国ICER为111,211.471美元/QALY。西米普利单抗的成本是模型中最具影响力的因素。这些模型的结果在所有敏感性分析中都很稳健。从美国公共支付者的角度来看,亚组分析表明,西米普利单抗对于鳞状细胞癌、腺癌或程序性细胞死亡配体1(PD-L1)≥1%的患者是一种具有成本效益的治疗方案。

结论

从美国公共支付者的角度来看,西米普利单抗是复发性宫颈癌二线治疗的一种具有成本效益的治疗选择。同时,西米普利单抗对于PD-L1≥1且所有组织学类型的患者都是一种具有成本效益的治疗方法。

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