HealthCore, Wilmington, Delaware.
Valeritas, Bridgewater, New Jersey.
J Manag Care Spec Pharm. 2019 Oct;25(10):1111-1123. doi: 10.18553/jmcp.2019.25.10.1111.
Coping with discomfort and the uncertainties of daily adjustments are prominent challenges confronting individuals with type 2 diabetes mellitus (T2DM) who require multiple daily injections (MDI) of insulin. For this growing population, wearable, disposable devices capable of delivering consistent and sustained doses of basal-bolus therapy may help to alleviate concerns and improve outcomes. However, studies on the comparative effectiveness of new, innovative delivery systems versus MDI on insulin requirements, glycemic control, and health care costs are sparse.
To examine glycemic control, insulin use, and diabetes medication costs for users of the V-Go Wearable Insulin Delivery device compared with MDI insulin therapy among individuals with T2DM in a commercially insured population in the United States.
This retrospective cohort study queried administrative claims data from the HealthCore Integrated Research Database from July 1, 2011, through July 31, 2017. Cohorts included individuals with T2DM aged 21-80 years either newly initiating V-Go or using MDI for basal/bolus insulin. The date of earliest claim for V-Go prescription fill or for bolus insulin was defined as the index date, depending on the cohort. Previous insulin therapy was required in both cohorts. Baseline hemoglobin A1c (A1c) values were identified during the 6 months before and 15 days after the index date; results closest to 12 months after the index date were selected as follow-up. Insulin use and diabetes medication cost data were examined during the 6 months baseline and the second half of the 1-year follow-up. V-Go and MDI users were 1:1 matched on baseline insulin exposure, A1c level, and other characteristics of interest. Univariate and multivariate tests were used to compare follow-up outcomes.
Matched cohorts included 118 well-balanced pairs (mean age: 56 years; mean baseline A1c: 9.2%). During follow-up, both cohorts experienced improvements in glycemic control relative to baseline (% with A1c ≤ 9%, baseline/follow-up: V-Go 49/69, < 0.001; MDI 50/60, = 0.046). With similar baseline insulin prescription fills and diabetes medication costs, V-Go users required fewer insulin prescription fills (mean change: -0.8 vs. +1.8 fills, < 0.001; -17% vs. +38%); had a smaller increase in diabetes medication costs (mean change in 2016 USD: $341 vs. $1,628, = 0.012; +10% vs. +47%); and a decrease in insulin total daily dose (mean change in insulin units per day: -29.2 vs. +5.8, < 0.001; -21% vs. +4%), compared with MDI users, during the last 6 months of follow-up.
This study was the first to evaluate clinical and economic outcomes associated with the use of V-Go for up to a 1-year follow-up period. Relative to MDI users, V-Go users had similar glycemic control but lower insulin use and lower diabetes medication costs during follow-up. V-Go therapy may provide an opportunity to improve quality measures more cost-effectively in people with T2DM who require basal-bolus therapy.
This study was funded by Valeritas. Nguyen is an employee of Valeritas. Zhou, Grabner, Barron, and Quimbo are employees of HealthCore, which received funding for this study from Valeritas. Raval was an employee of HealthCore at the time the study was conducted. Partial findings from this study were presented at the International Society of Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting; May 19-23, 2018; Baltimore, MD; and the 54th European Association for the Study of Diabetes Annual Meeting; October 1-5, 2018; Berlin, Germany.
对于需要每日多次注射胰岛素的 2 型糖尿病患者来说,应对不适和日常调整的不确定性是突出的挑战。对于这个不断增长的群体,能够提供持续稳定剂量的基础-餐时胰岛素治疗的可穿戴、一次性设备可能有助于减轻担忧并改善结果。然而,关于新的创新输送系统与每日多次注射胰岛素在胰岛素需求、血糖控制和医疗保健成本方面的比较效果的研究很少。
在美国商业保险人群中,比较 V-Go 可穿戴胰岛素输送装置与每日多次注射胰岛素治疗 2 型糖尿病患者的血糖控制、胰岛素使用和糖尿病药物费用。
这是一项回顾性队列研究,从 2011 年 7 月 1 日至 2017 年 7 月 31 日,从 HealthCore 综合研究数据库中查询行政索赔数据。队列包括年龄在 21-80 岁之间、新开始使用 V-Go 或使用每日多次注射胰岛素进行基础/餐时胰岛素治疗的 2 型糖尿病患者。V-Go 处方填充或餐时胰岛素的最早索赔日期被定义为索引日期,具体取决于队列。两个队列都需要之前的胰岛素治疗。在索引日期前的 6 个月和后 15 天内确定血红蛋白 A1c(A1c)的基线值;选择最接近索引日期后 12 个月的结果作为随访。在 6 个月的基线期和 1 年随访的下半年检查胰岛素使用和糖尿病药物费用数据。V-Go 和每日多次注射胰岛素使用者根据基线胰岛素暴露、A1c 水平和其他感兴趣的特征进行 1:1 匹配。使用单变量和多变量检验比较随访结果。
匹配的队列包括 118 对平衡良好的患者(平均年龄:56 岁;平均基线 A1c:9.2%)。在随访期间,与基线相比,两个队列的血糖控制均有所改善(A1c≤9%的患者比例:V-Go 49/69,<0.001;每日多次注射胰岛素 50/60,=0.046)。在胰岛素处方和糖尿病药物费用相似的情况下,V-Go 用户的胰岛素处方次数减少(平均变化:-0.8 次 vs. +1.8 次,<0.001;-17% vs. +38%);糖尿病药物费用增加较少(2016 年美元的平均变化:341 美元 vs. 1628 美元,=0.012;+10% vs. +47%);与每日多次注射胰岛素使用者相比,胰岛素总日剂量减少(平均变化:-29.2 单位/天 vs. +5.8 单位/天,<0.001;-21% vs. +4%),在最后 6 个月的随访期间。
这项研究是第一项评估使用 V-Go 长达 1 年随访期的临床和经济结果的研究。与每日多次注射胰岛素使用者相比,V-Go 用户的血糖控制相似,但在随访期间的胰岛素使用和糖尿病药物费用较低。V-Go 治疗可能为需要基础-餐时胰岛素治疗的 2 型糖尿病患者提供更具成本效益地改善质量措施的机会。
这项研究由 Valeritas 资助。Nguyen 是 Valeritas 的员工。Zhou、Grabner、Barron 和 Quimbo 是 HealthCore 的员工,HealthCore 为这项研究从 Valeritas 获得了资金。Raval 在进行这项研究时是 HealthCore 的员工。这项研究的部分结果在国际药物经济学和结果研究学会第 23 届年度国际会议上进行了介绍;2018 年 5 月 19 日至 23 日;马里兰州巴尔的摩;和第 54 届欧洲糖尿病研究协会年会;2018 年 10 月 1 日至 5 日;德国柏林。