Tzanetakos Charalampos, Tentolouris Nicholas, Kourlaba Georgia, Maniadakis Nikos
Department of Health Services Organization and Management, National School of Public Health, 196 Alexandras Avenue, 11521, Athens, Greece.
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, Athens, Greece.
Clin Drug Investig. 2016 Aug;36(8):649-59. doi: 10.1007/s40261-016-0410-2.
Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that has been spread worldwide over the past three decades and associated with increased morbidity and mortality resulting in considerable socioeconomic implications for national healthcare systems. Effective management of disease is highly needed ensuring patients receive the best possible care within the available budget. The objective of this study was to evaluate the long-term cost-effectiveness of dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, compared with a sulfonylurea (SU) or a dipeptidyl-peptidase-4 inhibitor (DPP-4i), when added to metformin, in T2DM patients inadequately controlled on metformin alone in Greece.
The published and validated Cardiff diabetes model, a lifetime micro-simulation model, was adapted to a Greek healthcare setting to determine the incidence of micro- and macro-vascular complications and diabetes-specific and all-cause mortality. Clinical, cost, and utility data were retrieved from literature and assigned to model parameters to calculate total quality-adjusted life-years (QALYs) and total costs as well as incremental cost-effectiveness ratios (ICERs). The analysis was conducted from the perspective of a third-party payer in Greece. Uncertainty surrounding important model parameters was explored with univariate and probabilistic sensitivity analyses (PSA).
Over a patient's lifetime, dapagliflozin was associated with 0.48 and 0.04 incremental QALYs compared with SU and DPP-4i, respectively, at additional costs of €5142 and €756, respectively. The corresponding ICERs were €10,623 and €17,695 per QALY gained versus the treatment with SU and DPP-4i, respectively. Results were robust across various univariate and scenario analyses. At the defined willingness-to-pay threshold of €34,000 per QALY gained, PSA estimated that treatment with dapagliflozin had a 100 % and 79.7 % probability of being cost-effective relative to the SU and DPP-4i treatments.
Dapagliflozin in combination with metformin was shown to be a cost-effective treatment alternative for patients with T2DM whose metformin regimen does not provide sufficient glycemic control in a Greek healthcare setting.
2型糖尿病（T2DM）是一种慢性进展性疾病，在过去三十年中已在全球范围内蔓延，并与发病率和死亡率增加相关，给国家医疗保健系统带来了相当大的社会经济影响。迫切需要对疾病进行有效管理，以确保患者在可用预算范围内获得尽可能好的护理。本研究的目的是评估与磺脲类药物（SU）或二肽基肽酶-4抑制剂（DPP-4i）相比，钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂达格列净在希腊单独使用二甲双胍血糖控制不佳的T2DM患者中添加二甲双胍时的长期成本效益。
已发表并经验证的卡迪夫糖尿病模型（一种终生微观模拟模型）被应用于希腊的医疗环境，以确定微血管和大血管并发症的发生率以及糖尿病特异性和全因死亡率。从文献中检索临床、成本和效用数据，并将其分配给模型参数，以计算总质量调整生命年（QALY）、总成本以及增量成本效益比（ICER）。该分析是从希腊第三方支付者的角度进行的。通过单变量和概率敏感性分析（PSA）探讨了重要模型参数周围的不确定性。
在患者的一生中，与SU和DPP-4i相比，达格列净分别增加了0.48和0.04个QALY，额外成本分别为5142欧元和756欧元。与SU和DPP-4i治疗相比，相应的ICER分别为每获得一个QALY 10623欧元和17695欧元。在各种单变量和情景分析中，结果都是稳健的。在定义的每获得一个QALY支付意愿阈值为34000欧元时，PSA估计与SU和DPP-4i治疗相比，达格列净治疗具有成本效益的概率分别为100%和79.7%。
在希腊的医疗环境中，对于二甲双胍治疗方案无法提供足够血糖控制的T2DM患者，达格列净联合二甲双胍被证明是一种具有成本效益的治疗选择。
