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从西班牙卫生系统角度对阿贝西利辅助治疗激素受体阳性、人表皮生长因子受体2阴性乳腺癌的经济学评估

Economic assessment of abemaciclib for the adjuvant treatment of luminal HER2- breast cancer from the perspective of the Spanish health system.

作者信息

Fenix-Caballero Silvia, Sanchez-Vegas Adrián, Alegre Del-Rey Emilio Jesús, Epstein David, Garcia-Mochon Leticia, Olry de Labry Lima Antonio

机构信息

Pharmacy Department, Hospital Universitario Puerto Real, Puerto Real, Spain.

Programa de doctorado en farmacia, Universidad de Granada, Granada, Spain.

出版信息

Eur J Health Econ. 2025 Feb;26(1):49-62. doi: 10.1007/s10198-024-01681-3. Epub 2024 Apr 22.

DOI:10.1007/s10198-024-01681-3
PMID:38647974
Abstract

INTRODUCTION

Abemaciclib is an oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Data from the clinical trial monarchE (2023) showed improved survival from invasive disease. The aim of the present article was to conduct an economic assessment of adjuvant treatment with abemaciclib in women with luminal, HER2- and node-positive breast cancer.

METHODS

A Markov model was constructed with four mutually exclusive health states (disease-free, local recurrence, distal recurrence and death). Analyses were based on the clinical trial monarchE which compared an intervention group (abemaciclib + hormone therapy [HT]) with HT alone. The effectiveness measure used was quality-adjusted life years (QALY), with unit costs and utilities being obtained from existing literature. The incremental cost-utility ratio (ICUR) was used to compare the two treatment strategies.

RESULTS

Total costs were €98,765 and €17,935 for the abemaciclib plus HT group and the HT alone group, respectively. The health outcome was 10.076QALY for the intervention group and 9.495QALY for the control group, with the ICUR being€139,173/QALY.

CONCLUSION

Despite the significant gains of abemaciclib as adjuvant treatment in terms of progression-free survival, this treatment is not cost-effective for the Spanish National Health System at published prices. It may be cost-effective with an appropriate discount on the official price.

摘要

引言

阿贝西利是一种细胞周期蛋白依赖性激酶4和6(CDK4/6)的口服抑制剂。临床试验monarchE(2023)的数据显示,侵袭性疾病的生存率有所提高。本文的目的是对阿贝西利辅助治疗激素受体阳性、人表皮生长因子受体2阴性且淋巴结阳性的乳腺癌女性患者进行经济学评估。

方法

构建了一个具有四个相互排斥健康状态(无病、局部复发、远处复发和死亡)的马尔可夫模型。分析基于临床试验monarchE,该试验将干预组(阿贝西利+激素治疗[HT])与单纯HT组进行了比较。使用的有效性指标是质量调整生命年(QALY),单位成本和效用值来自现有文献。采用增量成本-效用比(ICUR)来比较两种治疗策略。

结果

阿贝西利联合HT组和单纯HT组的总成本分别为98,765欧元和17,935欧元。干预组的健康结局为10.076QALY,对照组为9.495QALY,ICUR为139,173欧元/QALY。

结论

尽管阿贝西利作为辅助治疗在无进展生存期方面有显著获益,但就西班牙国家卫生系统而言,按公布价格,这种治疗不具有成本效益。如果官方价格有适当折扣,可能具有成本效益。

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