Malkin Samuel J P, Carvalho Davide, Costa Catarina, Conde Vasco, Hunt Barnaby
Ossian Health Economics and Communications GmbH, Bäumleingasse 20, 4051, Basel, Switzerland.
Department of Endocrinology, Diabetes and Metabolism, Centro Hospitalar Universitário de S João, Faculty of Medicine and Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Porto, Portugal.
Diabetol Metab Syndr. 2022 Feb 14;14(1):32. doi: 10.1186/s13098-022-00801-4.
Oral semaglutide is a novel glucagon-like peptide-1 (GLP-1) analog that has been associated with improvements in glycated hemoglobin (HbA1c) and body weight versus sodium-glucose cotransporter-2 inhibitor empagliflozin and injectable GLP-1 receptor agonist dulaglutide in the PIONEER 2 clinical trial and in a recent network meta-analysis (NMA), respectively. The aim of the present study was to evaluate the long-term cost-effectiveness of oral semaglutide 14 mg versus empagliflozin 25 mg and dulaglutide 1.5 mg for the treatment of type 2 diabetes from a healthcare payer perspective in Portugal.
In two separate analyses, outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9.0), discounted at 4% per annum. Clinical data were sourced from the PIONEER 2 trial and the NMA for the comparisons versus empagliflozin and dulaglutide, respectively. Patients were assumed to receive initial therapies until HbA1c exceeded 7.5%, then treatment-intensified to solely basal insulin therapy. Costs were accounted from a National Healthcare Service perspective in Portugal and expressed in 2021 euros (EUR). Utilities were taken from published sources.
Oral semaglutide 14 mg was associated with improvements in life expectancy of 0.10 and 0.03 years, and quality-adjusted life expectancy of 0.11 and 0.03 quality-adjusted life years (QALYs), versus empagliflozin 25 mg and dulaglutide 1.5 mg, respectively. Improved clinical outcomes were due to a reduced cumulative incidence and increased time to onset of diabetes-related complications with oral semaglutide. Total costs were projected to be EUR 2548 and EUR 814 higher with oral semaglutide versus empagliflozin and dulaglutide, with higher acquisition costs partially offset by cost savings from avoidance of diabetes-related complications. Oral semaglutide 14 mg was therefore associated with incremental cost-effectiveness ratios of EUR 23,571 and EUR 23,927 per QALY gained versus empagliflozin 25 mg and dulaglutide 1.5 mg, respectively.
Based on a willingness-to-pay threshold of EUR 30,000 per QALY gained, oral semaglutide 14 mg was considered cost-effective versus empagliflozin 25 mg and dulaglutide 1.5 mg for the treatment of type 2 diabetes in Portugal.
口服司美格鲁肽是一种新型胰高血糖素样肽-1（GLP-1）类似物，在先锋2期临床试验以及最近的一项网络荟萃分析（NMA）中，与糖化血红蛋白（HbA1c）改善和体重减轻相关，分别与钠-葡萄糖协同转运蛋白2抑制剂恩格列净和注射用GLP-1受体激动剂度拉糖肽相比。本研究的目的是从葡萄牙医疗保健支付方的角度评估口服司美格鲁肽14毫克与恩格列净25毫克和度拉糖肽1.5毫克治疗2型糖尿病的长期成本效益。
在两项单独的分析中，使用IQVIA CORE糖尿病模型（v9.0）预测患者一生中的结局，按每年4%进行贴现。临床数据分别来自先锋2期试验和NMA，用于与恩格列净和度拉糖肽的比较。假设患者接受初始治疗，直到HbA1c超过7.5%，然后强化治疗至仅使用基础胰岛素治疗。成本从葡萄牙国家医疗服务的角度进行核算，并以2021年欧元（EUR）表示。效用值来自已发表的资料。
与恩格列净25毫克和度拉糖肽1.5毫克相比，口服司美格鲁肽14毫克分别使预期寿命提高0.10年和0.03年，质量调整预期寿命提高0.11个质量调整生命年（QALY）和0.03个QALY。临床结局的改善归因于口服司美格鲁肽使糖尿病相关并发症的累积发生率降低和发病时间延长。预计口服司美格鲁肽的总成本比恩格列净和度拉糖肽分别高出2548欧元和814欧元，较高的购置成本部分被避免糖尿病相关并发症节省的成本所抵消。因此，与恩格列净25毫克和度拉糖肽1.5毫克相比，口服司美格鲁肽14毫克每获得一个QALY的增量成本效益比分别为23,571欧元和23,927欧元。
基于每获得一个QALY支付意愿阈值为30,000欧元，在葡萄牙，口服司美格鲁肽14毫克治疗2型糖尿病相对于恩格列净25毫克和度拉糖肽1.5毫克被认为具有成本效益。
