恩扎卢胺治疗转移性前列腺癌的成本-效果分析  

Cost-effectiveness analysis of enzalutamide in the treatment of metastatic prostate cancer

作　　者：杨雷 王凤玲 黄玲[2] 李燕[2] 郑寒蕊 郑玲利[2] 陈力[4] YANG Lei;WANG Fengling;HUANG Ling;LI Yan;ZHENG Hanrui;ZHENG Lingli;CHEN Li(Department of Urology,The First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,China;Department of Pharmacy,The First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,China;Department of Clinical Pharmacy,West China Hospital of Sichuan University,Chengdu 610041,China;Department of Pharmacy/Evidence-based Pharmacy Center,West China Second Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]成都医学院第一附属医院泌尿外科,成都610500 [2]成都医学院第一附属医院药学部,成都610500 [3]四川大学华西医院临床药学部,成都610041 [4]四川大学华西第二医院药学部/循证药学中心,成都610041

出　　处：《药物流行病学杂志》2024年第3期269-276,共8页Chinese Journal of Pharmacoepidemiology

基　　金：四川省科技厅项目(2019JDR0163);成都市医学科研课题(2023089)。

摘　　要：目的从我国医疗卫生角度出发,评价恩扎卢胺在转移性前列腺癌治疗中的成本-效果。方法基于已发表的Ⅲ期临床随机对照试验(ENZAMET研究),将转移性前列腺癌的的疾病发展过程分为无进展生存期、进展生存及死亡三种状态,模型周期定义为28 d,研究时限为终生,建立Markov模型,评价恩扎卢胺与标准抗雄激素药物治疗转移性前列腺癌的成本-效果,以3倍我国2022年人均国内生产总值作为意愿支付(WTP)阈值,通过敏感性分析验证模型分析结果的稳健性。结果与标准抗雄激素治疗相比,恩扎卢胺增量效果为0.92质量调整生命年(QALYs),增量成本为311863.30元,增量成本-效果比(ICER)为338981.85元/QALY,高于WTP阈值(257094元/QALY)。单因素敏感性分析结果显示,恩扎卢胺组总成本、疾病无进展期效用值、疾病进展期状态恩扎卢胺组的成本、恩扎卢胺单价对于模型结果影响较大。概率敏感性分析结果提示,在WTP阈值范围内,恩扎卢胺治疗方案不具有经济性。结论与标准抗雄激素药物相比,恩扎卢胺治疗转移性前列腺癌不具有成本-效果优势。Objective To evaluate the cost-effectiveness of enzalutamide in the treatment of metastatic prostate cancer from the perspective of healthcare in China.Methods Based on the published phaseⅢrandomized controlled trial(ENZAMET),the disease process of metastatic prostate cancer was classified into three states:progression-free survival,progression survival and death,and the model period was defined as 28 days,and the study period was lifelong,and a Markov model was established to evaluate the cost-effectiveness of the treatment of enzalutamide versus standard antiandrogen drugs in metastatic prostate cancer.Setting the willingness-to-pay(WTP)threshold at 3 times our 2022 gross domestic product(GDP)per capita and the robustness of the model analysis was verified by sensitivity analysis.Results Compared to the control group standard antiandrogen therapy,the incremental effect of enzalutamide was 0.92 quality-adjusted life years(QALYs),the incremental cost was 311863.30 yuan,and the incremental cost-effectiveness ratio(ICER)was 338981.85 yuan/QALY,which was higher than WTP threshold(257094 yuan/QALY).The results of univariate sensitivity analyses showed that the total cost of the enzalutamide group,the PFS utility value,the cost of the PD status of enzalutamide group,and the unit price of enzalutamide had a greater impact on the model results.The results of the probabilistic sensitivity analysis suggested that the enzalutamide treatment regimen was not economical within the willingness-to-pay threshold of 3 times our 2022 GDP per capita.Conclusion Compared with the standard anti-androgen drugs,enzalutamide does not offer a cost-effectiveness advantage in the treatment of metastatic prostate cancer.

关 键 词：恩扎卢胺 转移性前列腺癌 MARKOV模型 成本-效果分析 

分 类 号：R737.25[医药卫生—肿瘤] R956[医药卫生—临床医学]