舒格利单抗巩固治疗Ⅲ期非小细胞肺癌的药物经济学评价

Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stageⅢnon-small cell lung cancer

目的从我国卫生体系角度出发,评价舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期非小细胞肺癌(NSCLC)患者的经济性。方法基于GEMSTONE-301研究,建立三状态的分区生存模型模拟疾病发展进程,模型周期定义为3周,时间范围为终生;主要模型输出指标为总成本、质量调整生命年(QALY)和增量成本-效果比(ICER);采用5%的贴现率对成本和健康产出进行贴现。以1~3倍我国2022年人均国内生产总值(GDP)作为意愿支付阈值,采用成本-效用分析法进行分析,并采用情境分析和敏感性分析来验证模型的稳健性。结果与安慰剂相比,舒格利单抗巩固治疗方案的ICER为59872.57元/QALY,小于以1倍我国2022年人均GDP(85698元)作为的意愿支付阈值;情境分析结果进一步确定了模型的稳健性。单因素敏感性分析结果表明,药品(帕博利珠单抗、舒格利单抗、多西他赛)成本、疾病进展状态效用值等对ICER的影响较大。概率敏感性分析结果显示,在以1倍我国2022年人均GDP作为意愿支付阈值的前提下,舒格利单抗巩固治疗方案具有经济性的概率为67.2%;在以20000元[小于3倍我国2022年人均GDP(257094元)]作为意愿支付阈值时,舒格利单抗巩固治疗方案具有经济性的概率超过98%。结论舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期NSCLC具有经济性。

OBJECTIVE To evaluate the cost-effectiveness of sugemalimab in patients with stageⅢnon-small cell lung cancer(NSCLC)whose disease had not progressed after concurrent or sequential chemoradiotherapy from the perspective of the Chinese healthcare system.METHODS Based on the GEMSTONE-301 clinical trial,a three-health state partitioned survival model(PartSA)was developed to simulate the progression of disease,with model cycle of 3 weeks and a lifetime time range;the main output indicators of the model were total cost,quality-adjusted life year(QALY),and incremental cost-effectiveness ratio(ICER);the cost and health output were discounted using 5%discount rate.Using 1-3 times China’s per capita gross domestic product(GDP)in 2022 as the willingness-to-pay(WTP)threshold,the cost-utility analysis method was used for analysis,and sensitivity analysis and scenario analysis were conducted to assess model robustness.RESULTS Compared with placebo,ICER for sugemalimab consolidation therapy was 59872.57 yuan/QALY,which was less than one time China’s per capita GDP in 2022(85698 yuan)as the WTP threshold.The scenario analysis results further confirmed the robustness of the model.The results of single factor sensitivity analysis indicated that the cost of drugs(pembrolizumab,sugemalimab,docetaxel)and the utility value of disease progression status had a significant impact on ICER;the results of the probabilistic sensitivity analysis showed that sugemalimab had 67.2%probability of being cost-effective at one time China’s GDP per capita in 2022 as the WTP threshold;when 20000 yuan(less than 3 times GDP per capita in China of 257094 yuan)was used as the WTP threshold,the probability of sugemalimab consolidation therapy being cost-effective was greater than 98%.CONCLUSIONS The consolidation therapy with sugemalimab is cost-effective for stageⅢNSCLC whose disease had not progressed after concurrent or sequential chemoradiotherapy.