舒洛地特治疗慢性静脉功能不全患者的成本-效果分析

Cost-Effectiveness Analysis of Sulodexide in the Treatment of Chronic Venous Insufficiency

目的:评价舒洛地特对比地奥司明分别联合压力袜治疗5~6级(C5~C6,临床上根据静脉分类系统分级)的慢性静脉功能不全患者的成本-效果,为临床药物治疗及药品支付等相关决策提供参考。方法:本研究从医疗卫生服务体系角度出发,构建马尔可夫模型,对舒洛地特相比于地奥司明分别联合压力袜治疗临床分级C5~C6慢性静脉功能不全患者进行成本-效果分析,考虑舒洛地特口服治疗模式(情境1:口服)和序贯治疗模式(情境2:先注射后口服)两种情境,对相关关键影响参数进行敏感性分析。模型周期为3个月,分析5年跨度的成本数据和效应值(质量调整寿命年,quality-adjusted life years,QALYs)。其中,临床疗效数据和效用值数据来源于已公开发表的文献,成本数据来自于公开网站的中标价格及临床专家问卷调查。结果:采用舒洛地特口服药治疗(情境1)时,舒洛地特联合压力袜相比于地奥司明联合压力袜成本更低(8358元vs.11336元),效果更好(4.03 QALYs vs.4.01 QALYs)。敏感性分析结果显示,在全国2019年3倍人均GDP的阈值下,舒洛地特联合压力袜具有经济性的概率为90.33%。采用舒洛地特口服药及注射剂的序贯治疗(情境2)时,舒洛地特联合压力袜相比于地奥司明联合压力袜成本更低(10408元vs.11336元),效果更好(4.03 QALYs vs.4.01 QALYs);敏感性分析结果显示,舒洛地特联合压力袜具有经济性的概率为82.53%。结论:在中国成本环境中,对于临床分级为C5~C6的慢性静脉功能不全患者联合压力袜治疗时,舒洛地特相比于地奥司明的成本低,效果好,为绝对优势方案。

Objective:To evaluate the cost-effectiveness of sulodexide vs.diosmin(both in conjunction with compression stockings)in the treatment of chronic venous insufficiency(clinical classification:C5 to C6),in order to provide reference for clinical drug use and drug marketing.Methods:From the perspective of medical and health service system,a Markov model was constructed to compare the cost-effectiveness of sulodexide and diosmin combined with compression stockings in the treatment of chronic venous insufficiency(clinical classification:C5 to C6).Two scenarios were conducted:sulodexide oral therapy and sulodexide sequential therapy(starting with injection followed by oral).Both one-way and probabilistic sensitivity analyses(PSA)were performed.The Markov model cycle length was fixed at 3 months,and the model projected both treatment costs and health outcomes expressed in quality adjust life years(QALYs)over 5 years.The efficacy and utility data were derived from literature and the cost data was based on the drug procurement bidding price and the survey of clinical experts.Results:In scenario one,compared with diosmin,sulodexide had a lower treatment cost(￥8358 vs.￥11336),and greater gains in QALYs(4.03 vs.4.01).In scenario two,treatment with sulodexide instead of diosmin,also resulted in a lower cost(￥10408 vs.￥11336),and greater gains in QALYs(4.03 vs.4.01).Under the threshold of 3 times the national GDP per capita in 2019,PSA analysis indicated that sulodexide had probabilities of 90.33%and 82.53%being cost-effectiveness compared to diosmin in scenario 1 and scenario 2,respectively.Conclusion:Sulodexide is a dominant therapy in treatment of C5 to C6 chronic venous insufficient compared with diosmin(both in conjunction with compression stockings)in Chinese population,with low cost and good efficancy.