甘精胰岛素利司那肽注射液(Ⅰ)治疗中国血糖控制不佳的成人2型糖尿病患者的成本-效果分析

Cost-effectiveness Analysis of iGlarLixi(Ⅰ)in Adult Participants with Suboptimally Controlled Type 2 Diabetes Mellitus in China

目的评价中国血糖控制不佳的成人2型糖尿病(T2DM)患者使用甘精胰岛素利司那肽注射液(Ⅰ)(简称“甘精利司(Ⅰ)”)对比德谷胰岛素利拉鲁肽注射液(简称“德谷利拉”)的成本-效果。方法本研究立足于中国卫生服务体系视角,采用IQVIA CORE Diabetes Model系统评估甘精利司(Ⅰ)相较于德谷利拉用于口服降糖效果控制不佳的成人T2DM患者的长期健康产出、成本和成本-效果。甘精利司(Ⅰ)和德谷利拉的临床疗效数据来自两者在中国人群中开展的临床试验并通过间接比较计算两者的相对疗效;效用值及直接医疗成本参数则来自公开发表的文献。基础分析研究时限为全生命周期,以覆盖患者的长期治疗疗程;成本和质量调整生命年(QALYs)的贴现率均为5%。研究结果的稳健性通过敏感性分析验证。结果在口服降糖药控制不佳的成人T2DM患者中,甘精利司(Ⅰ)相较德谷利拉可提高患者生命质量,增量QALYs为0.045,并节省成本9355元。其中,QALYs的增量获益主要来自甘精利司(Ⅰ)更低的心血管事件发生率和微血管病变风险;成本优势则主要得益于甘精利司(Ⅰ)更低的日费用和相关并发症处理费用。单因素敏感性分析显示,贴现率和触发换线的糖化血红蛋白(Hb A1c)水平是影响成本-效果的主要因素;概率敏感性分析显示,以2023年中国0.5倍人均国内生产总值44679元作为意愿支付阈值,甘精利司(Ⅰ)相比于德谷利拉在口服降糖药控制不佳的成人T2DM患者中具有成本-效果优势的概率为92%,进一步证实了基础分析结果的稳健性。结论对比德谷利拉,甘精利司(Ⅰ)治疗口服降糖药控制不佳的成人T2DM患者健康获益更优,并发症事件更少,且成本更低,具有成本-效果优势。

Objectives To evaluate the cost-effectiveness of iGlarLixi(Ⅰ)compared with IDegLira in adult participants with suboptimally controlled type 2 diabetes Mellitus(T2DM)in China.Methods This study evaluates the long-term health outcomes,costs and cost-effectiveness of iGlarLixi(Ⅰ)versus IDegLira in suboptimally controlled participants on oral antidiabetic drug(OAD)using IQVIA CORE Diabetes Model(CDM).The clinical parameters of iGlarLixi(Ⅰ)and IDegLira were obtained from randomized clinical trials conducted in China and their relative efficacy was calculated using indirect treatment comparison.Utility and direct medical cost data were retrieved from published literature.This study was conducted from a healthcare system perspective,and a lifetime time horizon was used to simulate the long-term treatment course of participants with T2DM in base case analysis.The discount rate of costs and quality-adjusted life years(QALYs)was 5%.The robustness of the findings was assessed by sensitivity analyses.Results The research findings indicate that among OAD suboptimally controlled participants,those treated with iGlarLixi(Ⅰ)gained 0.045 QALYs and saved¥9355 over participants treated with IDegLira.The incremental benefit of QALY comes primarily from reduced incidence rates of cardiovascular and lower risk of microvascular associated with iGlarLixi(Ⅰ).The cost-saving advantage is largely due to the lower daily medication cost of iGarLixi(Ⅰ)and lower complication-related costs.Moreover,the one-way sensitivity analyses showed that discount rate and HbA1c threshold for treatment switching were key factors affecting the cost-effectiveness among OAD suboptimally controlled participants.Probabilistic sensitivity analyses showed that with the threshold of¥44679 which was 0.5 times of gross domestic product per capita in 2023 in China,the probabilities of iGlarLixi(Ⅰ)being cost-effective was 92%among OAD suboptimally controlled participants,further confirming the robustness of base case results.Conclusion In adults with poorly controlled oral hypoglycemic agents,iGlarLixi(Ⅰ)has better health benefits,fewer complications and lower cost than IDegLira in the treatment of T2DM patients with cost-effectiveness advantages.