多格列艾汀联用治疗二甲双胍失效2型糖尿病患者的成本-效用分析

Cost-utility analysis of dorzagliatin combined with metformin in the treatment of type 2 diabetes mellitus patients with poor glycemic control with metformin

目的对多格列艾汀联用治疗二甲双胍失效的2型糖尿病(T2DM)进行经济学评价。方法基于多格列艾汀联合二甲双胍治疗T2DM的Ⅲ期随机对照试验研究,建立Markov模型,从我国卫生体系角度出发,通过队列模拟预测各方案长期的成本与效用。以质量调整生命年(QALYs)为健康产出指标,以2022年人均国内生产总值(GDP)的3倍作为意愿支付阈值(WTP),分析增量成本-效果比(ICER),并进行敏感性分析和情境分析。结果模拟30年疾病进展后,与单用二甲双胍相比,多格列艾汀联合二甲双胍治疗可使有并发症的转移概率降低15.1%,死亡的转移概率降低8.5%,累计效用改善0.62 QALYs,ICER为235260.30元/QALY,小于WTP,增加的成本可接受。单因素敏感性分析结果表明,干预组无并发症成本、糖尿病无并发症效用值、糖尿病有并发症效用值对ICER影响较大。概率敏感性分析结果显示,多格列艾汀联合二甲双胍治疗方案具有经济性的概率为68.8%。情境分析结果表明,随着多格列艾汀价格的下降,联合治疗方案具有经济性的优势更明显。结论对于单用二甲双胍血糖控制不佳的T2DM患者,多格列艾汀联合二甲双胍治疗方案具有长期成本-效用优势,但具有经济性的概率仅近70%。

OBJECTIVE To evaluate the cost-effectiveness of dorzagliatin combined with metformin in the treatment of type 2 diabetes mellitus(T2DM)patients with poor glycemic control with metformin.METHODS A Markov model was established based on a phaseⅢrandomized controlled trial study of dorzagliatin combined with metformin in the treatment of T2DM.From the perspective of the Chinese health system,cohort simulation was used to predict the long-term cost-utility of each strategy.Using the quality-adjusted life years(QALYs)as the health output indicator,three times the 2022 gross domestic product(GDP)per capita as the willingness-to-pay threshold(WTP),the incremental cost-effectiveness ratio(ICER)was analyzed,then sensitivity analyses and scenario analysis were also performed.RESULTS After simulating 30 years of disease progression,compared with metformin,dorzagliatin combined with metformin reduced the probability of metastasis with complications by 15.1%,and the probability of death by 8.5%,improved cumulative utility by 0.62 QALYs,with an ICER of 235260.30 yuan/QALY,which was less than the WTP,and an acceptable increase in cost.The results of the single-factor sensitivity analysis showed that the ICER value was greatly affected by the cost of no complications in the intervention group,the utility value of diabetes without complications,and the utility value of diabetes with complications.Probabilistic sensitivity analysis showed that the probability of combination therapy being cost-effective was 68.8%.The results of scenario analysis showed that with the decline in the price of dorzagliatin,the combination therapy had more obvious economic advantages.CONCLUSIONS For T2DM patients with poor glycemic control with metformin alone,the combination of dorzagliatin and metformin has long-term cost-utility advantages,but the economic probability is only close to 70%.