恩格列净治疗射血分数降低型心力衰竭的成本—效果分析

Cost-effectiveness analysis harmacoeconomic evaluation of empagliflozin in the treatment of heart failure with reduced ejection fraction

目的 评价恩格列净联合标准治疗方案治疗射血分数降低型心力衰竭患者的成本-效果分析。方法 基于EMPEROR-Reduced试验的临床研究数据以及中国统计数据,构建循环周期为3个月、时限为10年的多状态Markov心力衰竭模型,以医疗卫生系统为研究角度,模拟恩格列净联合标准治疗方案(恩格列净组)和单独标准治疗方案(对照组)治疗射血分数降低型心力衰竭患者的质量调整生命年(QALYs)和直接医疗成本,利用成本-效果分析对恩格列净进行药物经济学评价。结果 与对照组方案相比,恩格列净组总人群成本为33 585.55元,高出对照组5223.34元,总效用值为3.98 QALYs,高出对照组0.14 QALYs;计算增量成本-效果比(ICER)值为36 849.47元/QALYs,低于我国2021年人均国内生产总值(GDP) 80 976.00元,非糖尿病人群与糖尿病人群模拟结果与总人群一致。单因素敏感性分析显示,在总人群中,心血管性死亡是成本-效果分析的最敏感因素。概率敏感性分析显示,在意愿支付(WTP)阈值为80 976.00元/QALYs时,总人群使用恩格列净联合标准治疗方案具有经济性的概率为60.3%。结论 与标准治疗方案相比,在总人群、非糖尿病人群和糖尿病人群中,恩格列净联合标准治疗方案治疗射血分数降低型心力衰竭具有药物经济学优势。

Objective To evaluate the economics and effectiveness of adding empagliflozin to standard treatment in the treatment of heart failure with reduced ejection fraction(HFrEF)in China.Methods A multistate Markov model was developed to yield clinical and economic outcomes of adding empagliflozin to standard treatment for 65-year-old patients with HFrEF.A cost-effectiveness analysis was performed mostly based on data from the EMPEROR-Reduced(Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction)trial and national statistical database.The primary outcome were total and incremental costs and quality-adjusted life years(QALYs)and the incremental cost-effectiveness ratio(ICER).Results Compared with the standard treatment,the cost of total population in the empagliflozin group was 33585.55 yuan,5223.34 yuan higher than that in the control group,and the total utility scores were 3.98 QALYs,0.14 QALYs higher than that in the control group,resulting in the calculated ICER of 36849.47 yuan/QALYs,which was lower than a willingness-to-pay(WTP)threshold of 80976.00 yuan/QALYs.The simulation results of non-diabetic and diabetic populations were consistent with the total populations.Univariate sensitivity analysis showed that cardiovascular death in both groups was the first driver of cost-effectiveness among total populations.Probability sensitivity analysis showed that when WTP was 80976.00 yuan/QALY,the probability of adding empagliflozin to standard therapy was 60.3%.Conclusion When WTP was 80976.00 yuan/QALY,adding empagliflozin to standard therapy was proved to be a little more cost-effective option for the treatment of HFrEF from a China healthcare system perspective, which promoted the rational use of empagliflozinfor HFrEF especially in diabetic populations.