双时相门冬胰岛素联用二甲双胍治疗2型糖尿病的成本-效果分析  

Cost-effectiveness of biphasic insulin aspart 30 combined with metformin in patients with type 2 diabetes mellitus

作　　者：李洪超[1] 徐菲[2] 王藩[3] 

机构地区：[1]中国药科大学国际医药商学院,南京210009 [2]北京大学中国卫生经济研究中心,北京100871 [3]武警总医院,北京100039

出　　处：《中国新药杂志》2011年第21期2163-2170,共8页Chinese Journal of New Drugs

摘　　要：目的:利用经济学模型,评价应用基础胰岛素治疗的中国2型糖尿病(T2DM)患者转换为双时相门冬胰岛素30(BIAsp30)联用二甲双胍治疗的长期经济与健康产出,证明BIAsp30的成本效果价值,旨在为临床医生和患者合理用药提供参考依据。方法:应用糖尿病CORE模型,计算患者长期(30年)的糖尿病治疗总成本、期望寿命和质量调整生命年。CORE模型是一项已发表的、经过验证和专家评审的、计算机模拟的糖尿病模型。293例中国T2DM患者的临床基线和治疗数据来自于一项16周、多中心和非随机无对照的用于评价基础胰岛素转用BIAsp30联合二甲双胍(MET)治疗的安全性与有效性的临床试验(NCT00614120)。其中基础胰岛素分为2个亚组,甘精胰岛素(IGla)联合MET组和中性鱼精蛋白锌胰岛素(NPH)联合MET组。药物和血糖检测的成本以市场价格计算,并发症及其管理成本是基于2008年已发表文献中的中国三级医院的糖尿病及其并发症成本数据进行CPI调整至2009年。本研究中的成本以直接医疗成本计算,包括降糖药物、血糖检测和糖尿病并发症的成本。直接医疗成本和质量调整生命年的年贴现率根据2006年中国药物经济学指南设定为3%。应用单因素敏感度分析评估研究结果的稳定性。结果:根据患者从使用IGla组转用BIAsp30联用MET治疗16周后的数据推算终身(30年)结果,治疗成本减少46 540元,期望寿命增加(0.347±0.245)年,质量调整生命年增加了(0.327±0.174)QALY。从使用NPH组转用BIAsp30治疗后,治疗成本增加19 525元,期望寿命增加(0.452±0.242)年,质量调整生命年增加了(0.393±0.169)QALY,计算得出增量成本效果比值(ICER)为49 730元/QALY。敏感性分析进一步验证了结果的稳健性。结论:从基础胰岛素转用BIAsp30联用MET治疗后,期望寿命与质量调整生命年均得到了增加。IGlar转用BIAsp30治疗后,减少治疗总成本。NPH转用BIAsp30治疗后Objectives： To evaluate the long-term cost-effectiveness of switching from basal insulin to biphasic insulin aspart 30 （BIAsp30） in patients with type 2 diabetes mellitus （T2DM） in China. Methods： A published and validated computer simulation model of diabetes （CORE Diabetes Model） was used to project long-term （30 years） of health and economic outcomes. Simulated cohorts and treatment effects were derived from a 16- week, multi-centre, and single-arm trial-NCT00669864, which investigated the efficacy and safety of BIAsp30 ＋ / - metformin in T2DM patients inadequately controlled with basal insulin. Two subgroups of basal insulin treatment were categorized as insulin glargine （IGlar） ＋/- metformin and neutral protamine hagedorn （NPH） insulin ＋ / - metformin. The market retail prices of medications were calculated to estimate treatment costs. The diabetes management and complication costs were obtained from the published data in China. An annual discounting rate of 3% was used for both costs and health outcomes. One-way sensitivity analysis was performed. Results： Therapy conversion to BIAsp30 was projected to improve life expectancy significantly in comparison with IGlar （0. 347 ＋ 0. 245 ） years and NPH （0. 452± 0. 242） years. Transfer to BIAsp30 was associated with improvements in 0. 327 quality-adjusted life years （QALY） over IGlar, and 0. 393 QALYs over NPH. Therapy conversion to BIAsp30 re- duced medical costs by Chinese Yuan （CNY） 46 540 per patient compared to IGlar. However, it increased CNY 19 525 compared to NPH, and was associated with an incremental cost-effectiveness ratio （ICER） of CNY 49 730 per QALY gained. Conclusion： Therapy conversion from basal insulin to BIAsp30 in T2DM patients in China is associated with improvements in life expectancy and QALYs. Transfer to BIAsp30 is cost-saving treatment strategy in T2DM patients managed with IGlar, and the cost-effective in T2DM patients managed with NPH would be considered. However, the calcula

关 键 词：双时相门冬胰岛素30 甘精胰岛素 中性鱼精蛋白锌胰岛素 期望寿命 质量调整生命年 成本节约 成本效果 

分 类 号：R977.15[医药卫生—药品]