甘精胰岛素利司那肽注射液(Ⅱ)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(Ⅱ)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(Ⅱ)(简称“甘精利司(Ⅱ)”),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。方法本研究采用IQVIA CORE Diabetes Model针对基础胰岛素控制不佳患者人群评价甘精利司(Ⅱ)对比德谷利拉的长期健康产出和成本。甘精利司(Ⅱ)和德谷利拉的临床疗效数据来自两者在中国基础胰岛素控制不佳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来自公开发表文献。研究视角为卫生体系视角;基础分析研究时限为全生命周期,以覆盖所有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%。研究结果通过敏感性分析验证稳健性。结果在基础胰岛素控制不佳人群中,甘精利司(Ⅱ)相较德谷利拉的增量QALYs为0.020,可节省成本7176元。甘精利司(Ⅱ)的成本优势主要来自药品费用单价显著低于德谷利拉,在使用剂量相当情况下,其日均费用可节约6.14元(13.44元vs.19.58元)。单因素敏感性分析显示,在基础胰岛素控制不佳人群中,触发换线的Hb A1c水平和研究时限是影响甘精利司(Ⅱ)对比德谷利拉的成本-效果的主要因素。概率敏感性分析显示,若以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(Ⅱ)相比德谷利拉在基础胰岛素控制不佳的人群中具有成本-效果优势的概率为88%,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(Ⅱ)治疗基础胰岛素控制不佳的成人T2DM患者的健康获益相当,但日均费用更低,具有成本-效果优势。

Objective To evaluate the cost-effectiveness of iGlarLixi(Ⅱ)compared with IDegLira in adult participants with suboptimally controlled type 2 diabetes mellitus(T2DM)in China.Methods IQVIA CORE Diabetes Model(CDM)was used to evaluate the long-term health outcomes and costs of iGlarLixi(Ⅱ)versus IDegLira on basal insulin(BI)suboptimally controlled participants.The clinical parameters of iGlarLixi and IDegLira were obtained from randomized clinical trials conducted in Chinese T2DM participants suboptimally controlled on BI and their relative efficacy was calculated using indirect treatment comparison.Utility and direct medical cost were retrieved from published literature.This study was conducted from a healthcare system perspective,and a lifetime time horizon was used to simulate outcomes 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 Among participants suboptimally controlled on BI,iGlarLixi(Ⅱ)was associated with incremental QALYs of 0.020 and saved¥7,176 over participants treated with IDegLira.Cost saving of iGlarLixi(Ⅱ)was primarily attributed to significantly lower unit price compared to IDegLira,resulting in a substantial saving of¥6.14 per day(¥13.44 for iGlarLixi(Ⅱ)vs.¥19.58 for IDegLira).The one-way sensitivity analyses showed that the HbA1c threshold for switching therapy and the time horizon of the study were the key factors affecting the cost-effectiveness among BI suboptimally controlled participants.Probabilistic sensitivity analyses showed that the probabilities of iGlarLixi(Ⅱ)being cost-effective was 88%among BI suboptimally controlled participants,under the threshold of half of gross domestic product per capita in 2023 in China,¥44679,further confirming the robustness of the base case results.Conclusion Compared with IDegLira,Suboptimally controlled T2DM participants on BI treated with iGlarLixi(Ⅱ)resulted in equivalent QALYs and a cost saving in China.