Centro de Investigación Biomédica en Red en Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Barcelona, Spain.
Primary Health Care Center Raval Sud, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de La Salut, Barcelona, Spain.
Adv Ther. 2022 Jul;39(7):3180-3198. doi: 10.1007/s12325-022-02156-8. Epub 2022 May 12.
Novel glucagon-like peptide-1 (GLP-1) receptor agonist oral semaglutide has demonstrated greater improvements in glycated hemoglobin (HbA1c) and body weight versus oral medications empagliflozin and sitagliptin, and injectable GLP-1 analog liraglutide, in the PIONEER clinical trial program. Based on these data, the present analysis aimed to evaluate the long-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin and liraglutide in Spain.
Outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9.0), discounted at 3.0% annually. Cohort characteristics and treatment effects were sourced from PIONEER 2 and 4 for the comparisons of oral semaglutide 14 mg versus empagliflozin 25 mg and liraglutide 1.8 mg, respectively, and PIONEER 3 for oral semaglutide 7 and 14 mg versus sitagliptin 100 mg. Costs were accounted from a healthcare payer perspective in 2020 euros (EUR). Patients were assumed to receive initial therapies until HbA1c exceeded 7.5% and then treatment-intensified to basal insulin.
Oral semaglutide 14 mg was associated with improvements in quality-adjusted life expectancy of 0.13, 0.19 and 0.06 quality-adjusted life years (QALYs) versus empagliflozin 25 mg, sitagliptin 100 mg and liraglutide 1.8 mg, respectively, with direct costs EUR 168 higher versus empagliflozin and EUR 236 and 1415 lower versus sitagliptin and liraglutide, respectively. Oral semaglutide 14 mg was associated with an incremental cost-effectiveness ratio (ICER) of EUR 1339 per QALY gained versus empagliflozin and was considered dominant (clinically superior and cost saving) versus sitagliptin and liraglutide. Additional analyses demonstrated that oral semaglutide 7 mg was associated with improvements of 0.11 QALYs and increased costs of EUR 226 versus sitagliptin and was therefore associated with an ICER of EUR 2011 per QALY gained.
Oral semaglutide 14 mg was dominant versus sitagliptin and liraglutide, and cost-effective versus empagliflozin, for the treatment of type 2 diabetes in Spain.
新型胰高血糖素样肽-1（GLP-1）受体激动剂口服司美格鲁肽在 PIONEER 临床试验项目中显示出在糖化血红蛋白（HbA1c）和体重方面优于口服药物恩格列净和西格列汀以及注射用 GLP-1 类似物利拉鲁肽。基于这些数据，本分析旨在评估口服司美格鲁肽与恩格列净、西格列汀和利拉鲁肽在西班牙的长期成本效益。
使用 IQVIA CORE Diabetes Model（v9.0）预测患者终生的结果，按 3.0%的年利率贴现。队列特征和治疗效果源自 PIONEER 2 和 4 研究，分别用于比较口服司美格鲁肽 14mg 与恩格列净 25mg 和利拉鲁肽 1.8mg，源自 PIONEER 3 研究，比较口服司美格鲁肽 7mg 和 14mg 与西格列汀 100mg。2020 年以欧元（EUR）为单位从医疗保健支付者的角度计算成本。假设患者接受初始治疗，直到 HbA1c 超过 7.5%，然后强化治疗至基础胰岛素。
与恩格列净 25mg、西格列汀 100mg 和利拉鲁肽 1.8mg 相比，口服司美格鲁肽 14mg 分别使质量调整预期寿命（QALYs）提高了 0.13、0.19 和 0.06 个质量调整生命年（QALY），直接成本比恩格列净高 EUR168，比西格列汀和利拉鲁肽分别低 EUR236 和 1415。与恩格列净相比，口服司美格鲁肽 14mg 的增量成本效益比（ICER）为每获得一个 QALY 增加 EUR1339，并且在临床上优于（具有成本效益）西格列汀和利拉鲁肽。其他分析表明，口服司美格鲁肽 7mg 与西格列汀相比，QALY 提高了 0.11，成本增加了 EUR226，因此每获得一个 QALY 的 ICER 为 EUR2011。
在西班牙，与西格列汀和利拉鲁肽相比，口服司美格鲁肽 14mg 是治疗 2 型糖尿病的首选药物，与恩格列净相比，具有成本效益。
