IMS Health, London, UK.
J Med Econ. 2012;15 Suppl 2:6-13. doi: 10.3111/13696998.2012.708691. Epub 2012 Jul 16.
The purpose of this study was to estimate the long-term cost-utility of treating type 2 diabetes mellitus (T2DM) patients with exenatide once weekly (EQW) compared with insulin glargine (IG) from a US payer perspective.
A validated computer simulation model, the CORE Diabetes Model, was used to project lifetime clinical outcomes and direct medical costs. Direct medical costs included pharmacy costs and costs associated with the management of diabetes and its complications. The model was populated using patient characteristics (mean age: 57.9 years; mean diabetes duration: 7.9 years; mean HbA1(c): 8.3%; mean body mass index [BMI]: 32.3 kg/m(2)) and clinical data from a phase 3 clinical trial that compared EQW with IG in T2DM patients on a background of metformin alone or a combination of metformin and a sulphonylurea (DURATION-3). All EQW patients were assumed to have stayed on treatment for 3 years before switching to IG. Health outcomes and costs were discounted at 3% per year. Complication costs were derived from published sources. A range of sensitivity analyses was performed.
Over a lifetime horizon, and compared with IG, EQW was associated with an incremental cost of $3914 (SD = 2923). EQW was projected to increase life expectancy by 0.135 (SD = 0.216) years and to improve quality-adjusted life expectancy by 0.246 (SD = 0.147) quality-adjusted life years (QALYs), generating an incremental cost-effectiveness ratio (ICER) of $15,936/QALY. Assuming a payer's willingness to pay threshold of $50,000/QALY, EQW is therefore cost-effective compared to IG. One-way and probabilistic sensitivity analyses confirmed EQW's cost-effective profile.
Short-term changes (26 weeks) in surrogate end-points (e.g., HbA1(c,) weight, complications) from one clinical trial were used to project long-term future effects on clinical outcomes.
Treatment with EQW is projected to be cost-effective compared to treatment with IG.
本研究旨在从美国支付者的角度评估每周一次给予艾塞那肽(EQW)与甘精胰岛素(IG)相比治疗 2 型糖尿病(T2DM)患者的长期成本-效用。
采用经过验证的计算机模拟模型——CORE 糖尿病模型,预测终生临床结局和直接医疗成本。直接医疗成本包括药物成本以及糖尿病及其并发症管理相关的成本。该模型采用患者特征(平均年龄:57.9 岁;平均糖尿病病程:7.9 年;平均糖化血红蛋白[HbA1c]:8.3%;平均体重指数[BMI]:32.3kg/m2)和一项 3 期临床试验的数据进行填充,该试验比较了 EQW 与单独使用二甲双胍或二甲双胍联合磺脲类药物(DURATION-3)的 T2DM 患者的 IG。所有 EQW 患者均假定在转为 IG 治疗前已连续治疗 3 年。健康结果和成本按每年 3%贴现。并发症成本源自已发表的资源。进行了一系列敏感性分析。
在终生期间,与 IG 相比,EQW 导致增量成本为 3914 美元(标准差[SD]=2923 美元)。EQW 预计将使预期寿命延长 0.135 年(SD=0.216),并使质量调整生命年(QALY)提高 0.246 年(SD=0.147),增量成本-效用比值(ICER)为 15936 美元/QALY。假设支付者愿意支付的阈值为 50000 美元/QALY,与 IG 相比,EQW 具有成本效益。单向和概率敏感性分析证实了 EQW 的成本效益特征。
使用一项临床试验中短期(26 周)替代终点(如 HbA1c、体重、并发症)的变化来预测对临床结局的长期未来影响。
与 IG 相比,预计使用 EQW 治疗具有成本效益。