Tunis Sandra L, Minshall Michael E, Conner Christopher, McCormick John I, Kapor Jovana, Yale Jean-François, Groleau Danielle
IMS Consulting Services, Falls Church, VA 22046, USA.
Curr Med Res Opin. 2009 May;25(5):1273-84. doi: 10.1185/03007990902869169.
This study was conducted to quantify the long-term cost-effectiveness of insulin detemir (Levemir) versus intermediate-acting neutral protamine Hagedorn (NPH) insulin for the treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in Canada, and to assess the sensitivity of results to dis-utilities for hypoglycemic events. dagger Levemir is a trade name of Novo Nordisk, Princeton, NJ, USA RESEARCH DESIGN AND METHODS: The web-based IMS-CORE diabetes model has a menu-driven interface programmed in hypertext markup language (HTML). It was used to project lifetime (60 years for T1DM and 35 years for T2DM) clinical and economic outcomes for patients on detemir vs. NPH. Cohort characteristics, utilities, and costs were derived from published literature. For T1DM, clinical trial data for HbA(1c) improvement (detemir -0.94% +/- 1.07; NPH -0.82% +/- 1.01) from baseline, and rates of hypoglycemic events (major events: 0.20 vs. 0.80 per patient-year for detemir vs. NPH, respectively) were modeled. For T2DM, observational study data for HbA(1c) improvement (detemir -0.18%) from baseline, and reductions in hypoglycemic events (major events: 0.0995 vs. 1.33 per patient-year for detemir vs. NPH, respectively) were modeled. Base-case hypoglycemia dis-utilities were -0.0118 for major and -0.0035 for minor events. Sensitivity analyses were conducted on discount rate and hypoglycemia dis-utility.
Outcomes included costs of treatment/management and costs (and incidence) of diabetes-related complications. Incremental cost-effectiveness ratios (ICERs) were calculated from differences in total costs and quality-adjusted life-years (QALYs).
Average total costs for T1DM were $CAN 83 622 +/- 4585 for detemir and $CAN 72 016 +/- 4593 for NPH. QALYs increased by 0.475 years with detemir, with an ICER of $CAN 24 389/QALY. Average direct costs for T2DM were $CAN 74 919 +/- 6391 (detemir) and $CAN 69 230 +/- 6840 (NPH). QALYs increased by 0.305 years. The ICER was $CAN 18 677. Although detemir was associated with slightly lower costs for most complications, results were driven by the differences in rates and costs for hypoglycemic events, and their assumed dis-utility. Study limitations include the use of single trials for clinical assumptions and the lack of analyses for patient risk sub-groups.
Findings provide evidence for the cost-effectiveness of detemir vs. NPH in treating T1 and T2DM in Canada, and support the key role of assumptions regarding the impact of hypoglycemic events. Additional work is needed to determine the extent to which results are robust for different sub-groups of patients and for variation in assumptions around HbA(1c) improvements and hypoglycemic event rates.
本研究旨在量化地特胰岛素(Levemir)与中效鱼精蛋白锌胰岛素(NPH)相比,用于治疗加拿大1型糖尿病(T1DM)和2型糖尿病(T2DM)的长期成本效益,并评估结果对低血糖事件失能调整的敏感性。†Levemir是美国新泽西州普林斯顿诺和诺德公司的商品名 研究设计与方法:基于网络的IMS-CORE糖尿病模型具有用超文本标记语言(HTML)编程的菜单驱动界面。它用于预测地特胰岛素与NPH治疗患者的终身(T1DM为60年,T2DM为35年)临床和经济结果。队列特征、效用和成本来自已发表的文献。对于T1DM,模拟了糖化血红蛋白(HbA1c)从基线改善的临床试验数据(地特胰岛素-0.94%±1.07;NPH-0.82%±1.01)以及低血糖事件发生率(主要事件:地特胰岛素和NPH分别为0.20和0.80次/患者年)。对于T2DM,模拟了HbA1c从基线改善的观察性研究数据(地特胰岛素-0.18%)以及低血糖事件减少情况(主要事件:地特胰岛素和NPH分别为0.0995和1.33次/患者年)。基础病例低血糖失能调整主要事件为-0.0118,次要事件为-0.0035。对贴现率和低血糖失能调整进行了敏感性分析。
结果包括治疗/管理成本以及糖尿病相关并发症的成本(和发生率)。增量成本效益比(ICER)根据总成本和质量调整生命年(QALY)的差异计算得出。
T1DM的平均总成本地特胰岛素为83622加元±4585,NPH为72016加元±4593。使用地特胰岛素QALY增加了0.475年,ICER为24389加元/QALY。T2DM的平均直接成本地特胰岛素为74919加元±6391,NPH为69230加元±6840。QALY增加了0.305年。ICER为18677加元。尽管地特胰岛素对大多数并发症的成本略低,但结果是由低血糖事件的发生率和成本差异及其假定的失能调整驱动的。研究局限性包括临床假设使用单一试验以及缺乏对患者风险亚组的分析。
研究结果为地特胰岛素与NPH在加拿大治疗T1和T2DM的成本效益提供了证据,并支持关于低血糖事件影响假设的关键作用。需要进一步开展工作,以确定结果在不同患者亚组以及HbA1c改善和低血糖事件发生率假设变化方面的稳健程度。