University of Groningen, Faculty of Science and Engineering, Groningen Research Institute of Pharmacy, A. Deusinglaan 1, 9713 AV, Groningen, The Netherlands.
Expertise Center for Methodology and Information Services, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
Pharmacoeconomics. 2023 Oct;41(10):1249-1262. doi: 10.1007/s40273-023-01286-3. Epub 2023 Jun 10.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been shown to reduce the risk of cardiovascular complications, which largely drive diabetes' health and economic burdens. Trial results indicated that SGLT2i are cost effective. However, these findings may not be generalizable to the real-world target population. This study aims to evaluate the cost effectiveness of SGLT2i in a routine care type 2 diabetes population that meets Dutch reimbursement criteria using the MICADO model.
Individuals from the Hoorn Diabetes Care System cohort (N = 15,392) were filtered to satisfy trial inclusion criteria (including EMPA-REG, CANVAS, and DECLARE-TIMI58) or satisfy the current Dutch reimbursement criteria for SGLT2i. We validated a health economic model (MICADO) by comparing simulated and observed outcomes regarding the relative risks of events in the intervention and comparator arm from three trials, and used the validated model to evaluate the long-term health outcomes using the filtered cohorts' baseline characteristics and treatment effects from trials and a review of observational studies. The incremental cost-effectiveness ratio (ICER) of SGLT2i, compared with care-as-usual, was assessed from a third-party payer perspective, measured in euros (2021 price level), using a discount rate of 4% for costs and 1.5% for effects.
From Dutch individuals with diabetes in routine care, 15.8% qualify for the current Dutch reimbursement criteria for SGLT2i. Their characteristics were significantly different (lower HbA1c, higher age, and generally more preexisting complications) than trial populations. After validating the MICADO model, we found that lifetime ICERs of SGLT2i, when compared with usual care, were favorable (< €20,000/QALY) for all filtered cohorts, resulting in an ICER of €5440/QALY using trial-based treatment effect estimates in reimbursed population. Several pragmatic scenarios were tested, the ICERs remained favorable.
Although the Dutch reimbursement indications led to a target group that deviates from trial populations, SGLT2i are likely to be cost effective when compared with usual care.
钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i)已被证明可降低心血管并发症的风险,而心血管并发症在很大程度上导致了糖尿病的健康和经济负担。试验结果表明 SGLT2i 具有成本效益。然而,这些发现可能不适用于真实世界的目标人群。本研究旨在使用 MICADO 模型,评估符合荷兰报销标准的常规护理 2 型糖尿病患者中 SGLT2i 的成本效益。
从霍恩糖尿病护理系统队列(N=15392)中筛选出符合试验纳入标准(包括 EMPA-REG、CANVAS 和 DECLARE-TIMI58)或符合当前荷兰 SGLT2i 报销标准的个体。我们通过比较来自三项试验的干预组和对照组的事件相对风险的模拟和观察结果,验证了一个健康经济学模型(MICADO),并使用该模型根据筛选出的队列的基线特征和来自试验和观察研究综述的治疗效果,评估长期健康结果。从第三方支付者的角度评估 SGLT2i 与常规护理相比的增量成本效益比(ICER),以欧元(2021 年价格水平)衡量,使用 4%的贴现率对成本进行贴现,对效果进行 1.5%的贴现。
在常规护理的荷兰糖尿病患者中,15.8%符合当前荷兰 SGLT2i 的报销标准。他们的特征与试验人群明显不同(较低的 HbA1c、较高的年龄和普遍更多的预先存在的并发症)。在验证了 MICADO 模型之后,我们发现,与常规护理相比,在所有筛选出的队列中,SGLT2i 的终生 ICER 都是有利的(<20000 欧元/QALY),在符合报销条件的人群中,使用基于试验的治疗效果估计,ICER 为 5440 欧元/QALY。测试了几种务实的方案,ICER 仍然有利。
尽管荷兰的报销指征导致目标人群与试验人群存在差异,但与常规护理相比,SGLT2i 很可能具有成本效益。