Health Economics & Outcomes Research, IMS Health, Falls Church, Virginia 22046, USA.
Clin Ther. 2010 Sep;32(10):1756-67. doi: 10.1016/j.clinthera.2010.08.010.
Nearly half of all US patients with type 2 diabetes mellitus (T2DM) are unable to maintain adequate glycosylated hemoglobin (HbA₁(c)) control (ie, <7.0%).
The aim of this work was to determine the long-term cost-effectiveness of incretin-based therapy with once-daily liraglutide (vs twice-daily exenatide) combined with metformin, glimepiride, or both for the treatment of T2DM.
Patient data were obtained from the Liraglutide Effect and Action in Diabetes 6 (LEAD 6) trial. Baseline data included mean HbA₁(c) (8.15%), age (56.7 years), disease duration (8 years), sex, body mass index, blood pressure, lipid levels, cardiovascular and renal risk factors, and other complications. The IMS Center for Outcomes Research Diabetes Model was used to project and compare lifetime (ie, 35-year) clinical and economic outcomes for once-daily liraglutide 1.8 mg compared with twice-daily exenatide 10 (ig, each used as add-on therapy with maximum-dose metformin and/or glimepiride. Treatment-effect assumptions were also derived from the LEAD 6 trial. Transition probabilities, utilities, and complication costs were obtained from published sources. All outcomes were discounted at 3% per annum, and the analysis was conducted from the perspective of a third-party payer in the United States.
The base-case analysis indicated that, compared with exenatide, liraglutide add-on therapy was associated with a mean (SD) increase in life expectancy of 0.187 (0.250) years and an increase in qualityadjusted life-years of 0.322 (0.164) years. Compared with exenatide, total lifetime treatment costs for liraglutide were $12,956 higher, yielding an incremental costeffectiveness ratio (ICER) of $40,282. However, the costs of diabetes-related complications were lower with liraglutide than with exenatide ($49,784 vs $52,429, respectively). Sensitivity analysis indicated that setting patient HbA(1c) levels at the 95% upper limit reduced the ICER for liraglutide compared with exenatide to $33,086.
In this model analysis using published clinical data and current medication acquisition price assumptions, liraglutide (in combination with metformin and/or glimepiride) appeared to be cost-effective in the US payer setting over a 35-year time horizon.
近一半的美国 2 型糖尿病(T2DM)患者无法维持足够的糖化血红蛋白(HbA₁(c))控制(即,<7.0%)。
本研究旨在确定每日一次利拉鲁肽(与每日两次艾塞那肽相比)联合二甲双胍、格列美脲或两者联合治疗 T2DM 的长期成本效益。
患者数据来自利拉鲁肽疗效和作用 6 期(LEAD 6)试验。基线数据包括平均 HbA₁(c)(8.15%)、年龄(56.7 岁)、疾病持续时间(8 年)、性别、体重指数、血压、血脂水平、心血管和肾脏危险因素以及其他并发症。IMS 中心为成果研究糖尿病模型用于预测和比较每日一次利拉鲁肽 1.8mg 与每日两次艾塞那肽 10(ig)的终生(即 35 年)临床和经济结果,两种药物均作为最大剂量二甲双胍和/或格列美脲的附加疗法。治疗效果的假设也来自 LEAD 6 试验。转移概率、效用和并发症成本均来自已发表的资料。所有结果均按每年 3%贴现,分析从美国第三方支付者的角度进行。
基础分析表明,与艾塞那肽相比,利拉鲁肽附加疗法与预期寿命平均增加 0.187 年(0.250 年)和质量调整生命年增加 0.322 年(0.164 年)相关。与艾塞那肽相比,利拉鲁肽的终生总治疗费用高出 12956 美元,增量成本效果比(ICER)为 40282 美元。然而,利拉鲁肽的糖尿病相关并发症成本低于艾塞那肽(分别为 49784 美元和 52429 美元)。敏感性分析表明,将患者的 HbA(1c)水平设定在 95%上限将使利拉鲁肽相对于艾塞那肽的 ICER 降低至 33086 美元。
在这项使用已发表的临床数据和当前药物获取价格假设的模型分析中,利拉鲁肽(联合二甲双胍和/或格列美脲)在 35 年时间范围内似乎在美国支付者环境中具有成本效益。