奥加伊妥珠单抗用于难治或复发性B细胞急性淋巴细胞白血病的成本效用分析  

Cost-utility analysis of inotuzumab ozogamicin for refractory or relapsed B-cell acute lymphoblastic leukemia

作　　者：马国强 郑淼淼 洪望龙 朱文涛 沈爱宗 MA Guoqiang;ZHENG Miaomiao;HONG Wanglong;ZHU Wentao;SHEN Aizong(School of Pharmacy,Anhui University of Chinese Medicine,Anhui Hefei 230011,China;Department of Pharmacy,The First Affiliated Hospital of University of Science and Technology of China,Anhui Hefei 230001,China)

机构地区：[1]安徽中医药大学药学院,安徽合肥230011 [2]中国科学技术大学第一附属医院药剂科,安徽合肥230001

出　　处：《中国医院药学杂志》2023年第20期2275-2279,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:从中国卫生体系的角度评价奥加伊妥珠单抗方案与标准治疗方案治疗难治或复发性B细胞急性淋巴细胞白血病(R/R B-ALL)的经济性。方法:基于Ⅲ期临床试验(INO-VATE ALL),构建分区生存模型,模拟时限50年或模拟队列中99%的患者死亡,循环周期4周,评价奥加伊妥珠单抗组相对于标准治疗组治疗时所产生的增量成本-效用比,采用5%贴现率,并进行敏感性分析验证基础分析结果的稳定性。结果:奥加伊妥珠单抗组患者比标准治疗组患者多获得1.49个质量调整生命年(QALYs)的同时,增加了770238.88元成本,ICER为518412.63元/QALY,高于我国的意愿支付(WTP)阈值;单因素敏感性分析显示对ICER影响最大的3个因素分别为贴现率、无进展状态效用值、奥加伊妥珠单抗的价格;概率敏感性分析显示,当WTP阈值为3倍人均国内生产总值(GDP)时,奥加伊妥珠单抗方案对于标准化疗方案不具有经济性。结论:对于难治或复发性B细胞急性淋巴细胞白血病,奥加伊妥珠单抗方案不具有经济性。OBJECTIVE To evaluate the economics of ogaituzumab regimen versus standard regimen for the treatment of refractory or relapsed B-cell acute lymphoblastic leukemia(R/R B-ALL)from the perspective of China's health system.METHODS Based on the phaseⅢclinical trial(INO-VATE ALL),a partitioned survival model was constructed,with a simulated time frame of 50 years or the death of 99%of patients in the simulated cohort,with a cycle period of 4 weeks,and the incremental cost-utility ratio generated by the experimental group of oxaituzumab compared with the control group of standard therapy was evaluated,and a discount rate of 5%was used,and sensitivity analysis was performed to verify the stability of the basic analysis results.RESULTS Patients in the ogaituzumab group obtained 1.49 more quality-adjusted life years(QALYs)than those in the standard treatment group,while increasing the cost by 770238.88 yuan,and the ICER was 518412.63 yuan/QALY,which was higher than the willingness-to-pay(WTP)threshold in China.Univariate sensitivity analysis showed that the three factors with the greatest impact on ICER were discount rate,progression-free utility value,and price of ogaituzumab.Probabilistic sensitivity analysis showed that oxgaituzumab regimens were not economical for standard chemotherapy regimens when the WTP threshold was 3 times gross domestic product(GDP)per capita.CONCLUSION For refractory or recurrent B-cell acute lymphoblastic leukemia,the regimen of oxgaituzumab is not cost-effective.

关 键 词：急性淋巴细胞白血病 成本-效用分析 分区生存模型 奥加伊妥珠单抗 

分 类 号：R973[医药卫生—药品]