钠-葡萄糖协同转运蛋白2抑制剂治疗射血分数保留及轻度降低的心力衰竭:基于中国医疗条件下的成本效果分析

Sodium-glucose cotransporter 2 inhibitors for heart failure with preserved or mildly reduced ejection fraction:A cost-effectiveness analysis in China setting

目的 比较在中国射血分数保留及轻度降低的心力衰竭(心衰)患者中标准治疗与标准治疗联合钠-葡萄糖协同转运蛋白2抑制剂的成本效果。方法 构建Markov模型,对我国射血分数保留及轻度降低的心衰患者进行成本效果模拟。模拟周期为3个月,时长为10年。成本来自于中国心衰注册研究,效用来自于已经发表的基于中国心衰患者的研究。临床事件转移概率来自已经发表的多中心随机对照实验EMPEROR-Preserved和DELIVER研究。主要结局为增量成本效果比(ICER),次要结局包括增量成本、增量效果,总成本,总效果,基于国产同类药品的ICER。若得到的ICER<1倍中国人均GDP的,则认为具有较高的成本效果,介于1~3倍人均GDP认为具有成本效果,>3倍人均GDP则认为不具有成本效果。若结果显示,SGLT2i不具备成本效果或具备成本效果但是成本效果不高,则计算具备成本效果时的药物成本。结果 经过10年模拟,恩格列净组患者增量成本为7697元,增量效果为0.078质量调整生命年(QALY),ICER为98248元/QALY,是1.2倍人均GDP。达格列净组患者增量成本为8135元,增量效果为0.082,ICER为98722元/QALY,是1.2倍人均GDP。国产同类药品显示恩格列净具备较高的成本效果,达格列净具备成本效果,但是成本效果不高。原研药恩格列净和达格列净若需要达到较高的成本效果,则需降价至当前价格的83%。结论 我国HFp EF/HFmr EF患者的标准治疗中加入SGLT2i是具备成本效果的,但是成本效果不高,主要是因为SGLT2i对心血管死亡和全因死亡的改善效果不明显,而如果想要达到较高的成本效果,需要降价至当前价格的83%。还需要更多的真实世界研究证实我们的结论。

Objective To investigate the cost-effectiveness of standard therapy versus standard therapy plus sodium-glucose cotransporter 2 inhibitors(SGLT2i)in Chinese heart failure patients with preserved(HFpEF)or mildly reduced ejection fraction(HFmrEF).Method A Markov model was constructed to simulate the costeffectiveness of heart failure patients with preserved or mildly reduced ejection fraction in China.The simulation cycle was 3 months and the time horizon was 10 years.The costs were derived from China Heart Failure Registry and utility was obtained from a published paper conducted in China setting.The transition probability of clinical events was obtained from the multicenter randomized controlled trials of EMPEROR-Preserved and DELIVER studies.The primary outcome was incremental cost-effectiveness ratio(ICER),and the secondary outcomes included incremental cost,incremental effectiveness,total cost,total effectiveness and ICER based on the cost of domestic drugs.If the ICER obtained was less than 1 time of per capita GDP in China,SGLT2i was considered to be highly cost-effective;it was cost-effective if ICER was 1-3 times of per capita GDP;and it was not costeffective if ICER was more than 3 times of per capita GDP.If the results showed that SGLT2i were not costeffective or that they were cost-effective but not highly cost-effective,the cost of the drug when they were costeffective were calculated.Results After a simulation of 10 years,the incremental cost of patients in the empagliflozin cohort was 7697 Chinese Yuan(CNY),and the incremental effectiveness was 0.078 qualityadjusted life years(QALY)and the ICER was 98,248 CNY/QALY,which was 1.2 times of per capita GDP in China.The incremental cost in dapagliflozin group was 8135 CNY and the incremental effectiveness was 0.082 QALY,resulting in an ICER of 98,722 CNY/QALY,which was 1.2 times of per capita GDP.Domestic similar drugs showed that empagliflozin was highly cost-effective,and dapagliflozin was cost-effective but not so highly.The original drugs of empagliflozin and dapagliflozin would need to be reduced to 83%of the current price to achieve high cost-effectiveness.Conclusion Adding SGLT2i to the standard treatment of HFpEF/HFmrEF patients in China is cost-effective,but not highly cost-effective,mainly because the improvement of SGLT2i on cardiovascular death and all-cause death is not obvious.To get the highly cost-effectiveness,the cost of SGLT2i would need to be reduced to 83%of the current price.The conclusion needs to be confirmed by more real-world studies.