IMS Health, London, UK.
J Med Econ. 2012;15(4):654-63. doi: 10.3111/13696998.2012.670677. Epub 2012 Mar 12.
Exenatide once-weekly (ExQW) is a GLP-1 receptor agonist shown to lower glucose and cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the clinical benefits and associated economic benefits of treatment with ExQW compared with sitagliptin or pioglitazone in the US.
The IMS CORE Diabetes Model, a validated computer simulation model, was used to project lifetime clinical outcomes and complication costs. The costs of glucose-lowering drugs were excluded as not all prices were available. Baseline patient characteristics (mean values: age, 52.5 years; diabetes duration, 6 years; HbA1(c), 8.51%; body mass index, 32.12 kg/m(2)) and clinical data were derived from a phase 3 clinical trial that compared ExQW with sitagliptin or pioglitazone in T2DM patients. At 6 months, patients treated with ExQW had greater improvements in HbA1(c) and body weight than those treated with sitagliptin or pioglitazone. Complication costs were extracted from published sources. Health outcomes and costs were discounted at 3% per year. Sensitivity analyses were performed.
Over 35 years, and compared with sitagliptin or pioglitazone, ExQW increased life expectancy by, respectively, 0.28 (13.76 ± 0.17 vs 13.48 ± 0.18) and 0.17 years (13.76 ± 0.17 vs 13.59 ± 0.17), and quality-adjusted life years by, respectively, 0.28 (9.56 ± 0.12 vs 9.28 ± 0.12) and 0.24 years (9.56 ± 0.12 vs 9.32 ± 0.12). ExQW was associated with lower lifetime complication costs: compared with sitagliptin or pioglitazone, ExQW saved, respectively US$2215 (US$55,647 ± 2039 vs US$57,862 ± 2159) and US$933 (US$55,647 ± 2039 vs US$56,580 ± 2007) direct cost per patient. Cost-savings resulted mainly from a lower projected cumulative incidence of cardiovascular diseases and neuropathic complications.
Short-term changes in surrogate end-points were used to project lifetime effects on clinical outcomes. Pharmacy costs were excluded from the analyses.
Over a patient's lifetime, ExQW was projected to improve health and decrease diabetes-related complication costs compared with sitagliptin or pioglitazone.
艾塞那肽每周一次(ExQW)是一种 GLP-1 受体激动剂,已被证明可降低 2 型糖尿病(T2DM)患者的血糖和心血管风险因素。本研究的目的是估计与西格列汀或吡格列酮相比,在美国使用 ExQW 治疗的临床获益和相关的经济效益。
使用经过验证的计算机模拟模型 IMS CORE Diabetes Model 来预测终生的临床结果和并发症成本。由于并非所有价格均可用,因此未计入降血糖药物的成本。基线患者特征(平均值:年龄,52.5 岁;糖尿病病程,6 年;HbA1(c),8.51%;体重指数,32.12kg/m2)和临床数据来自一项 3 期临床试验,该试验比较了 ExQW 与 T2DM 患者的西格列汀或吡格列酮。在 6 个月时,接受 ExQW 治疗的患者的 HbA1(c)和体重改善大于接受西格列汀或吡格列酮治疗的患者。并发症成本从已发表的资料中提取。健康结果和成本按每年 3%贴现。进行了敏感性分析。
在 35 年内,与西格列汀或吡格列酮相比,ExQW 分别使预期寿命增加了 0.28 年(13.76 ± 0.17 与 13.48 ± 0.18)和 0.17 年(13.76 ± 0.17 与 13.59 ± 0.17),并使质量调整生命年分别增加了 0.28 年(9.56 ± 0.12 与 9.28 ± 0.12)和 0.24 年(9.56 ± 0.12 与 9.32 ± 0.12)。ExQW 与较低的终生并发症成本相关:与西格列汀或吡格列酮相比,ExQW 分别节省了 2215 美元(55647 美元 ± 2039 美元与 57862 美元 ± 2159 美元)和 933 美元(55647 美元 ± 2039 美元与 56580 美元 ± 2007 美元)每位患者的直接成本。节省成本主要归因于心血管疾病和神经病变并发症的累积发生率预计较低。
使用短期替代终点的变化来预测对临床结局的终生影响。分析中未计入药房成本。
在患者的一生中,与西格列汀或吡格列酮相比,预计 ExQW 可改善健康状况并降低与糖尿病相关的并发症成本。