Department of Pharmaceutical Administration, Faculty of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom.
Front Public Health. 2020 Oct 30;8:562023. doi: 10.3389/fpubh.2020.562023. eCollection 2020.
ADVANCE was a large, multinational clinical study conducted over 5 years in type 2 diabetes mellitus (T2DM). In all, 11,140 patients were randomly assigned to receive gliclazide-based intensive glucose control (IGC) or standard glucose control (SGC). IGC was shown to significantly reduce the incidence of major macrovascular and microvascular events (composite endpoint) or major microvascular events compared with SGC, primarily by enhancing renal protection. We assessed the cost-effectiveness of IGC vs. SGC, based on the ADVANCE results, from a Vietnamese healthcare payer perspective. A partitioned survival times model across five health states (no complications, myocardial infarction, stroke, end-stage renal disease [ESRD], and diabetes-related eye-disease) was designed. Time-to-event curves were informed by the cumulative incidence of events and corresponding hazard ratios from the ADVANCE study. Health outcomes were expressed in terms of ESRD avoided and quality-adjusted life years (QALYs). Costs (in US $) comprised treatment costs and health state costs. Utility weights and costs were documented from literature reporting Vietnamese estimates. For sensitivity analyses, all parameters were individually varied within their 95% confidence interval bounds (when available) or within a ±30% range. Over a 5-year horizon, IGC avoided 6.5 additional ESRD events per 1,000 patients treated compared with SGC (IGC, 3.5 events vs. SGC, 10.0 events) and provided 0.016 additional QALYs (IGC, 3.570 QALYs vs. SGC, 3.555 QALYs). Total costs were similar for the two strategies (IGC, $3,786 vs. SGC, $3,757). Although the total drug costs were markedly higher for IGC compared with SGC ($1,703 vs. $873), this was largely offset by the savings from better renal protection with IGC (IGC, $577 vs. SGC, $1,508). The incremental cost-effectiveness ratio (ICER) of IGC vs. SGC was $1,878/QALY gained, far below the threshold recommended by the World Health Organization (i.e., 1-3 × gross domestic product per inhabitant ≈$7,500 in Vietnam). The ICER of IGC vs. SGC per ESRD event avoided was $4,559/event. The findings were robust to sensitivity analysis. In Vietnam, gliclazide-based IGC was shown to be cost-effective compared with SGC from a healthcare payer perspective, as defined in the ADVANCE study.
ADVANCE 是一项大型的、多国的 2 型糖尿病临床研究，历时 5 年。共有 11140 名患者被随机分配接受基于格列齐特的强化血糖控制（IGC）或标准血糖控制（SGC）。与 SGC 相比，IGC 显著降低了主要大血管和微血管事件（复合终点）或主要微血管事件的发生率，主要通过增强肾脏保护。我们根据 ADVANCE 研究结果，从越南医疗保健支付者的角度评估了 IGC 与 SGC 的成本效益。我们设计了一个跨越五个健康状态（无并发症、心肌梗死、中风、终末期肾病[ESRD]和糖尿病相关眼病）的分区生存时间模型。时间事件曲线由 ADVANCE 研究中事件的累积发生率和相应的风险比提供信息。健康结果以避免的 ESRD 和质量调整生命年（QALY）表示。成本（以美元计）包括治疗成本和健康状态成本。效用权重和成本来自报告越南估计值的文献。对于敏感性分析，所有参数都在其 95%置信区间范围内（如果可用）或在±30%范围内进行了单独的变化。在 5 年的时间内，IGC 每 1000 名接受治疗的患者避免了 6.5 例额外的 ESRD 事件，而 SGC 为 10.0 例（IGC 为 3.5 例，SGC 为 10.0 例），并提供了 0.016 个额外的 QALY（IGC 为 3.570 QALY，SGC 为 3.555 QALY）。两种策略的总费用相似（IGC，3786 美元；SGC，3757 美元）。尽管与 SGC 相比，IGC 的总药物成本明显更高（IGC，1703 美元；SGC，873 美元），但 IGC 更好的肾脏保护作用节省了大量成本（IGC，577 美元；SGC，1508 美元）。IGC 与 SGC 的增量成本效益比（ICER）为 1878 美元/QALY，远低于世界卫生组织（WHO）建议的阈值（即，1-3×人均国内生产总值，越南约为 7500 美元）。IGC 每避免 1 例 ESRD 事件的 ICER 为 4559 美元/例。敏感性分析结果稳健。在越南，从医疗保健支付者的角度来看，基于格列齐特的 IGC 在 ADVANCE 研究中被证明是具有成本效益的，符合标准。
