The health and budget impact of sodium-glucose co-transporter-2 inhibitors (SGLT2is) in the Netherlands

Type-2 Diabetes Mellitus (T2DM) increases both the patient risk of cardiovascular disease (CVD) and renal outcomes, such as chronic kidney disease (CKD). Recent clinical trials of the glucose-lowering drug-class of sodium-glucose co-transporter-2 inhibitors (SGLT2is) have shown benefits in preventing CVD events and progression of CKD, leading to an update of the Dutch T2DM treatment guideline for patients at risk. The aim of this study is to assess the health and economic impact of the guideline-recommended utilisation of SGLT2is in the Netherlands. The patient population at risk was determined by multiplying Dutch T2DM prevalence rates with the total numbers of inhabitants of the Netherlands in 2020. Subsequently, two analyses, comparing a treatment setting before and after implementation of the new guideline for SGLT2is, were conducted. Clinical and adverse event rates in both settings as well as direct healthcare costs were sourced from the literature. Total costs were calculated by multiplying disease prevalence, event rates and costs associated to outcomes. One-time disutilities per event were included to estimate the health impact. The potential health and economic impact of implementing the updated guideline was calculated. Using a 5-year time horizon, the guideline-suggested utilisation of SGLT2is resulted in a health impact equal to 4,835 quality adjusted life years gained (0.0031 per patient per year) and €461 million cost-savings. The costs of treatment with SGLT2is were €813 million. Hence the net budget impact was €352 million for the total Dutch T2DM population, which translated to €0,57 per patient per day. SGLT2is offer an option to reduce the number of CVD and CKD related events and associated healthcare costs and health losses in the Netherlands. Further research is needed to include the benefits of improved T2DM management options from a broader societal perspective.

2型糖尿病（Type 2 Diabetes Mellitus, T2DM）会同时升高患者罹患心血管疾病（Cardiovascular Disease, CVD）及慢性肾脏病（Chronic Kidney Disease, CKD）等肾脏不良结局的风险。近年来，针对钠-葡萄糖协同转运蛋白2抑制剂（Sodium-Glucose Co-Transporter-2 Inhibitors, SGLT2is）这一降糖药物类别的临床试验证实，其可有效预防心血管事件发生并延缓慢性肾脏病进展，推动了荷兰针对高危2型糖尿病患者的治疗指南更新。
本研究旨在评估荷兰地区指南推荐使用钠-葡萄糖协同转运蛋白2抑制剂所带来的健康与经济影响。
研究通过将2020年荷兰2型糖尿病患病率乘以该国总人口数，确定了高危患者人群规模。随后开展了两项对比分析，分别比较钠-葡萄糖协同转运蛋白2抑制剂新指南实施前后的治疗场景。
两种治疗场景下的临床结局、不良事件发生率以及直接医疗成本均来源于已发表文献。总成本通过疾病患病率、事件发生率与结局相关成本的乘积计算得出，同时纳入单次事件带来的失能效用值以估算健康影响。
研究测算出了更新指南实施后潜在的健康与经济影响：以5年为时间跨度，指南推荐的钠-葡萄糖协同转运蛋白2抑制剂使用方案可带来4835个质量调整生命年的健康获益（每位患者每年0.0031个），并实现4.61亿欧元的成本节约。
钠-葡萄糖协同转运蛋白2抑制剂的治疗总成本为8.13亿欧元，因此荷兰整体2型糖尿病人群的净预算影响为3.52亿欧元，折算后每位患者每日的成本为0.57欧元。
钠-葡萄糖协同转运蛋白2抑制剂可有效降低荷兰地区心血管疾病与慢性肾脏病相关事件的发生数量，同时减少与之相关的医疗成本与健康损失。未来仍需开展进一步研究，从更广泛的社会视角纳入2型糖尿病管理方案优化所带来的获益。