Torre Enrico, Bruno Giacomo Matteo, Di Matteo Sergio, Martinotti Chiara, Oselin Martina, Valentino Maria Chiara, Parodi Alessio, Bottaro Luigi Carlo, Colombo Giorgio Lorenzo
Endocrinology, Diabetology and Metabolic Diseases Unit, ASL3, Genoa, Italy.
S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy.
Clinicoecon Outcomes Res. 2018 Jul 26;10:413-421. doi: 10.2147/CEOR.S169045. eCollection 2018.
Diabetes represents a relevant public health problem worldwide due to its increasing prevalence and socioeconomic burden. There is no doubt that tight glycemic control reduces the development of diabetic complications such as the long-term costs related to the disease. The aim of our model was to calculate total direct costs associated with the two treatments considered in DUAL VII study, and hence evaluate the potential economic benefits for the National Health System (NHS) deriving from the use of insulin degludec plus liraglutide (IDegLira) in a once-daily fixed combination.
We applied the cost-minimization technique adopting the NHS point of view to the DUAL VII trial outcomes. In the model, developed in Microsoft Excel, we calculated and compared annual costs per patient of the two therapeutic options for type 2 diabetes (T2D) patients not achieving glycemic control on basal insulin and metformin described in the trial, including costs of therapy management and side effects, both negative and positive. Annual treatment costs were calculated based on IDegLira and basal bolus end-of-trial doses resulting in a 1:2 ratio (40.4 U vs 84.1 U). Therefore, maintaining the IDegLira/basal bolus at 1:2 dose ratio, we calculated the correlation between the dose reduction and costs compared to DUAL VII doses base case scenario.
Total treatment costs were obtained by adding annual cost of drug, needles, glycemic self-monitoring, hypoglycemic events, and effect on consumption of other drugs. Total annual costs of IDegLira combination resulted in €434 higher than basal bolus in DUAL VII base case (40.4 U); the two treatments reported equal costs at 34% dose reduction (26.7 U), while below this value IDegLira treatment became less expensive, with about €215 gain at 50% dose reduction (20.2 U). It is also important to notice that above the break-even point, until an IDegLira dose of 30 U, the cost difference is negligible in view of the clinical benefit provided by the fixed combination highlighted in DUAL VII trial.
Adding the significant clinical findings derived from DUAL VII trial to our economic evaluation, IDegLira seems to offer an important alternative to basal-bolus therapy.
由于糖尿病患病率不断上升及其社会经济负担，它已成为全球一个重大的公共卫生问题。毫无疑问，严格的血糖控制可减少糖尿病并发症的发生，比如与该疾病相关的长期成本。我们模型的目的是计算与DUAL VII研究中所考虑的两种治疗方法相关的总直接成本，从而评估每日一次固定剂量联合使用德谷胰岛素利拉鲁肽（IDegLira）给国家卫生系统（NHS）带来的潜在经济效益。
我们从NHS的角度，将成本最小化技术应用于DUAL VII试验结果。在Microsoft Excel中开发的模型里，我们计算并比较了试验中描述的在基础胰岛素和二甲双胍治疗下未实现血糖控制的2型糖尿病（T2D）患者两种治疗方案的人均年度成本，包括治疗管理成本以及负面和正面的副作用成本。年度治疗成本是根据IDegLira和基础大剂量胰岛素在试验结束时的剂量按1:2的比例（40.4 U对84.1 U）计算得出的。因此，将IDegLira/基础大剂量胰岛素维持在1:2的剂量比例，我们计算了与DUAL VII剂量基础案例相比剂量减少与成本之间的相关性。
总治疗成本通过将药物、针头、血糖自我监测、低血糖事件以及对其他药物消耗的影响的年度成本相加得出。在DUAL VII基础案例（40.4 U）中，IDegLira联合治疗的年度总成本比基础大剂量胰岛素高434欧元；在剂量降低34%（26.7 U）时，两种治疗方法的成本相等，而低于此值时，IDegLira治疗成本更低，在剂量降低50%（20.2 U）时可节省约215欧元。同样重要的是要注意，在盈亏平衡点以上，直到IDegLira剂量达到30 U，鉴于DUAL VII试验中突出显示的固定组合所带来的临床益处，成本差异可以忽略不计。
将DUAL VII试验得出的重大临床发现纳入我们的经济评估后，IDegLira似乎为基础大剂量胰岛素治疗提供了一个重要的替代方案。
