达格列净联合二甲双胍治疗2型糖尿病的药物经济学评价
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篇名: 达格列净联合二甲双胍治疗2型糖尿病的药物经济学评价
TITLE: Pharmacoeconomic Evaluation of Dapagliflozin Combined with Metformin in the Treatment of Type 2 Diabetes Mellitus
摘要: 目的:对达格列净联合二甲双胍治疗2型糖尿病进行经济学评价。方法:基于达格列净联合二甲双胍治疗2型糖尿病的3期随机对照临床试验(RCT)及相关文献,建立二甲双胍单用或联合达格列净治疗2型糖尿病的Markov模型,分别对5mg达格列净联合二甲双胍、10mg达格列净联合二甲双胍及二甲双胍单用3种方案(二甲双胍的用量均为1500mg)治疗2型糖尿病的无并发症、有并发症和死亡3种状态的动态变化进行模拟。以质量调整生命年(QALYs)作为健康产出指标,以2019年国内生产总值的3倍作为意愿支付阈值,运用Markov模型进行队列模拟获得3种方案治疗2型糖尿病的长期效果与成本,分析增量成本-效用比(ICER),同时对成本、效用和贴现进行敏感性分析,检验分析结果的稳定性。结果:Markov模型队列模拟结果显示,在为期10年的疾病进展后,与单用二甲双胍比较,5mg达格列净联合二甲双胍的ICER为41259.17元/QALYs,10mg达格列净联合二甲双胍的ICER为92824.85元/QALYs;与5mg达格列净联合二甲双胍比较,10mg达格列净联合二甲双胍的ICER为1209525.95元/QALYs;将终止时间延长至20、30年后对结果无影响。敏感度分析显示,各参数在设定的范围内变化不影响模型分析结论,研究结果稳健。结论:对于2型糖尿病患者而言,5mg达格列净联合二甲双胍的方案更具有成本-效用优势。
ABSTRACT: OBJECTIVE:To evaluate the economic value of dapagliflozin combined with metformin in the treatment of type 2 diabetes mellitus (T2DM). METHODS :Based on related literatures and phase 3 randomized controlled clinical trial (RCT)of metformin alone or combined with dapagliflozin for T2DM,Markov model was built to simulate the dynamic changes of 3 schemes such as 5 mg dapagliflozin combined with metformin ,10 mg dapagliflozin combined with metformin or metformin alone (the dose of metformin were all 1 500 mg)in the treatment of T 2DM patients without or with complications and death . Quality adjusted life years(QALYs)was used as a health output indicator and the threshold of willingness-to-pay was 3 times of GDP in 2019. Cohort simulation in Markov model was applied to obtain long-term effect and cost of 3 schemes in the treatment of T 2DM. The incremental cost-effectiveness ratio (ICER)was analyzed ;the sensitivity of cost ,utility and discount was analyzed to check the stability of the analysis result. RESULTS :According to the results of Markov model cohort simulation ,after 10 years of disease progression,compared with metformin alone ,ICER of 5 mg dapagliflozin combined with metformin was 41 259.17 yuan/QALYs, and that of 10 mg dapagliflozin combined with metformin was 92 824.85 yuan/QALYs. Compared with 5 mg dapagliflozin combined with metformin ,ICER of 10 mg dapagliflozin combined with metformin was 1 209 525.95 yuan/QALYs. Extension of termination time to 20 or 30 years had no effect on results. According to the sensitivity analysis ,the change of key parameters in the set range did not affect the model results ,indicating the result was stable. CONCLUSIONS :For T 2DM,5 mg dapagliflozin combined with metformin is more cost-effective .
期刊: 2020年第31卷第15期
作者: 熊朝刚,朱玉蓉,李颖,冯柯臻,封卫毅
AUTHORS: XIONG Chaogang ,ZHU Yurong ,LI Ying,FENG Kezhen ,FENG Weiyi
关键字: 2型糖尿病;达格列净;二甲双胍;成本-效用;Markov模型;药物经济学
KEYWORDS: Type 2 diabetes mellitus ;Dapagliflozin;Metformin;Cost-effectiveness;Markov model ;Pharmacoeconomics
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