Evroston LP, Athens, Greece.
Diabetes Centre, Department of Internal Medicine, Konstantopouleio Hospital, Athens, Greece.
Clin Drug Investig. 2018 May;38(5):417-426. doi: 10.1007/s40261-018-0620-x.
Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece.
A health economic model was used to project clinical and economic outcomes of patients receiving empagliflozin plus SoC compared with those receiving SoC alone over a lifetime horizon. CV and renal event rates were derived from patient level data from the EMPA-REG-OUTCOME trial by fitting time-dependent parametric survival functions. 5000 individual patient profiles randomly sampled from the trial were simulated using a time-to-event approach. Model extrapolated outcomes included life years (LYs), quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER). Following a Greek third-party payer perspective, only direct medical costs related to drug acquisition as well as fatal and non-fatal diabetes-related complications were considered (€2016). Cost units and utility data were extracted from the literature and publicly available official sources. Sensitivity analyses explored the impact of changes in input data.
Over a patient's lifetime, empagliflozin was predicted to result in longer mean survival (14.01 LY vs. 11.87 LY with SoC) and reduced rate of clinical events accumulating 7.75 QALYs versus 6.83 QALYs on SoC alone at additional costs of €4235. The generated ICER of empagliflozin was €4633 per QALY gained. One-way sensitivity analysis confirmed empagliflozin's cost-effective profile. At the defined willingness-to-pay threshold of €34,000 per QALY gained, probabilistic sensitivity analysis showed that empagliflozin was estimated to have a 100% probability of being cost-effective relative to SoC.
Empagliflozin added to SoC was estimated to be a highly cost-effective treatment option for the treatment of T2DM in adults with increased CV disease risk in Greece.
2 型糖尿病（T2DM）常伴有使心血管（CV）风险恶化的合并症。CV 疾病是全球糖尿病患者死亡的主要原因，约占 T2DM 人群死亡人数的一半。因此，本研究旨在评估恩格列净除标准治疗（SoC）以外，用于治疗希腊 T2DM 合并高 CV 风险成人患者的成本效益。
使用健康经济学模型预测接受恩格列净联合 SoC 治疗的患者与单独接受 SoC 治疗的患者在终生内的临床和经济结局。CV 和肾脏事件发生率来自 EMPA-REG-OUTCOME 试验的患者水平数据，通过拟合时依赖参数生存函数得出。使用事件时间方法对来自试验的 5000 名随机抽样的个体患者进行模拟。模型外推结果包括寿命年（LY）、质量调整寿命年（QALY）、成本和增量成本效益比（ICER）。基于希腊第三方支付者的观点，仅考虑与药物获得以及致命和非致命糖尿病相关并发症相关的直接医疗成本（2016 欧元）。成本单位和效用数据取自文献和公开的官方来源。敏感性分析探讨了输入数据变化的影响。
在患者的一生中，预计恩格列净治疗将导致更长的平均寿命（恩格列净治疗为 14.01LY，SoC 治疗为 11.87LY），并减少单独使用 SoC 时累计 7.75QALY 的临床事件发生率，而单独使用 SoC 的成本为 4235 欧元。恩格列净的 ICER 为每获得 1QALY 增加 4633 欧元。单因素敏感性分析证实了恩格列净的成本效益特征。在定义的每获得 1QALY 支付意愿阈值为 34000 欧元时，概率敏感性分析表明，与 SoC 相比，恩格列净估计有 100%的概率具有成本效益。
在希腊，与 SoC 相比，恩格列净联合 SoC 治疗估计是治疗 T2DM 合并高 CV 疾病风险成人患者的一种极具成本效益的治疗选择。
