Woehl Anette, Evans Mark, Tetlow Anthony P, McEwan Philip
School of Mathematics, Cardiff University, Cardiff, UK.
Cardiovasc Diabetol. 2008 Aug 11;7:24. doi: 10.1186/1475-2840-7-24.
Exenatide belongs to a new therapeutic class in the treatment of diabetes (incretin mimetics), allowing glucose-dependent glycaemic control in type 2 diabetes. Randomised controlled trial data suggest that exenatide is as effective as insulin glargine at reducing HbA1c in combination therapy with metformin and sulphonylureas; with reduced weight but higher incidence of adverse gastrointestinal events. The objective of this study is to evaluate the cost effectiveness of exenatide versus insulin glargine using RCT data and a previously published model of type 2 diabetes disease progression that is based on the United Kingdom Prospective Diabetes Study; the perspective of the health-payer of the United Kingdom National Health Service.
The study used a discrete event simulation model designed to forecast the costs and health outcome of a cohort of 1,000 subjects aged over 40 years with sub-optimally-controlled type 2 diabetes, following initiation of either exenatide, or insulin glargine, in addition to oral hypoglycaemic agents. Sensitivity analysis for a higher treatment discontinuation rate in exenatide patients was applied to the cohort in three different scenarios; (1) either ignored or (2) exenatide-failures excluded or (3) exenatide-failures switched to insulin glargine. Analyses were undertaken to evaluate the price sensitivity of exenatide in terms of relative cost effectiveness. Baseline cohort profiles and effectiveness data were taken from a published randomised controlled trial.
The relative cost-effectiveness of exenatide and insulin glargine was tested under a variety of conditions, in which insulin glargine was dominant in all cases. Using the most conservative of assumptions, the cost-effectiveness ratio of exenatide vs. insulin glargine at the current UK NHS price was -29,149 pounds/QALY (insulin glargine dominant) and thus exenatide is not cost-effective when compared with insulin glargine, at the current UK NHS price.
This study evaluated the relative cost effectiveness of insulin glargine versus exenatide in the management of type 2 diabetes using a published model. Given no significant difference in glycaemic control and applying the additional effectiveness of exenatide over insulin glargine, with respect to weight loss, and using the current UK NHS prices, insulin glargine was found to be dominant over exenatide in all modelled scenarios. With current clinical evidence, exenatide does not appear to represent a cost-effective treatment option for patients with type 2 diabetes when compared to insulin glargine.
艾塞那肽属于糖尿病治疗中的一类新型治疗药物（肠促胰岛素类似物），可实现2型糖尿病患者基于血糖水平的血糖控制。随机对照试验数据表明，在与二甲双胍和磺脲类药物联合治疗时，艾塞那肽降低糖化血红蛋白（HbA1c）的效果与甘精胰岛素相当；能减轻体重，但胃肠道不良事件的发生率较高。本研究的目的是利用随机对照试验数据以及先前发表的基于英国前瞻性糖尿病研究的2型糖尿病疾病进展模型，从英国国家医疗服务体系健康支付方的角度，评估艾塞那肽与甘精胰岛素的成本效益。
本研究使用了一个离散事件模拟模型，旨在预测1000名40岁以上2型糖尿病控制不佳的患者在开始使用艾塞那肽或甘精胰岛素并联合口服降糖药后的成本和健康结局。针对艾塞那肽治疗组更高的停药率，在三种不同情景下对该队列进行了敏感性分析：（1）忽略该情况；（2）排除艾塞那肽治疗失败的患者；（3）将艾塞那肽治疗失败的患者换用甘精胰岛素。进行分析以评估艾塞那肽在相对成本效益方面的价格敏感性。基线队列概况和有效性数据取自已发表的随机对照试验。
在多种条件下测试了艾塞那肽和甘精胰岛素的相对成本效益，结果显示在所有情况下甘精胰岛素都更具优势。采用最保守的假设，按照英国国家医疗服务体系当前的价格，艾塞那肽与甘精胰岛素的成本效益比为-29,149英镑/质量调整生命年（甘精胰岛素更具优势），因此与甘精胰岛素相比，按照英国国家医疗服务体系当前的价格，艾塞那肽不具有成本效益。
本研究使用已发表的模型评估了甘精胰岛素与艾塞那肽在2型糖尿病管理中的相对成本效益。鉴于血糖控制无显著差异，且考虑到艾塞那肽相对于甘精胰岛素在减重方面的额外效果，按照英国国家医疗服务体系当前的价格，在所有模拟情景中甘精胰岛素都优于艾塞那肽。根据目前的临床证据，与甘精胰岛素相比，艾塞那肽似乎并非2型糖尿病患者具有成本效益的治疗选择。
