Evidera, Waltham, MA.
The Leona M. and Harry B. Helmsley Charitable Trust, New York, NY.
J Manag Care Spec Pharm. 2020 Nov;26(11):1399-1410. doi: 10.18553/jmcp.2020.26.11.1399.
Approximately 5%-10% of patients with diabetes are diagnosed with type 1 diabetes mellitus (T1DM), the incidence and prevalence of which is projected to increase through 2050. Despite this, T1DM-related health care resource utilization (HCRU) and economic burden in the United States have not been adequately assessed, since previous studies used various cost definitions and underlying methods to examine these outcomes. To assess HCRU and costs incurred by patients with T1DM in the United States. This retrospective cohort study used IBM Watson MarketScan data from 2011 to 2015 and Optum's electronic medical record (EMR) and integrated data (i.e., linked EMR and administrative claims data) from 2011 to 2016. Included patients had ≥ 1 T1DM diagnosis (the earliest diagnosis date was designated as the index date), were continuously enrolled for ≥ 6 months during their pre-index baseline periods, and had ≥ 1 pharmacy claim for insulin or an insulin pump within ± 90 days of the index date. Baseline demographic and clinical characteristics were summarized descriptively. Average monthly HCRU and costs per patient per month (PPPM) paid by the health plan and patient were assessed. Costs were adjusted for inflation to 2018 U.S. dollars. We identified 181,423 patients with T1DM who met the selection criteria in MarketScan, 84,759 in the Optum EMR, and 8,948 in the Optum integrated databases. Most patients were male (range across databases: 52.6%-53.1%), relatively young (medians: 33-35 years, overall range: 0-100 years), and had a Charlson Comorbidity Index score of 1 (69.2%-73.0%) across all databases. Total all-cause and diabetes-related costs ranged from $1,482 to $1,522 and $733 to $780 PPPM, respectively, during the follow-up period. Pharmacy costs contributed most to the total cost of care, accounting for 55.3% ($431) to 61.1% ($448) of total diabetes-related costs. On an annualized basis, patients had an average of 0.2-0.9 all-cause hospitalizations and 0.1-0.3 diabetes-related hospitalizations during follow-up. The median costs per diabetes-related hospitalization ranged from $6,548 to $8,439, accounting for 4%-7% of total monthly diabetes-related costs. Patients had an average of 0.4-0.5 all-cause and 0.1-0.2 diabetes-related emergency department (ED) visits annually; the median costs of ED visits were $972-$1,499, contributing about 2% of monthly diabetes-related costs during follow-up. In this large, retrospective, observational study of pediatric and adult patients with T1DM, diabetes-related costs totaled nearly $800 per month. Pharmacy costs contributed to over half of diabetes-related costs, indicating the substantial economic burden associated with the treatment of T1DM. Additional research is needed to determine risk factors associated with costly events (e.g., hospitalizations and ED visits) and indirect costs associated with T1DM. JDRF International provided funding for this project and manuscript. JDRF International also contracted with Evidera, a research and consulting firm for the biopharma industry, for its participation in the project and in the development of this manuscript. The Leona M. and Harry B. Helmsley Charitable Trust provided JDRF International with funding. Simeone, Shah, and Ganz are employed by Evidera and do not receive any payment or honoraria directly from Evidera's clients. LeGrand is an employee of JDRF International. Bushman was employed by JDRF International during the conduct of the study and development of this manuscript. Sullivan and Koralova are employees of The Leona M. and Harry B. Helmsley Charitable Trust.
约 5%-10%的糖尿病患者被诊断为 1 型糖尿病(T1DM),预计其发病率和患病率将在 2050 年前增加。尽管如此,在美国,T1DM 相关的医疗保健资源利用(HCRU)和经济负担尚未得到充分评估,因为以前的研究使用了各种成本定义和基础方法来研究这些结果。本回顾性队列研究使用了 IBM Watson MarketScan 数据库(2011 年至 2015 年)和 Optum 的电子病历(EMR)和综合数据(即,链接 EMR 和行政索赔数据)(2011 年至 2016 年)。纳入的患者至少有 1 次 T1DM 诊断(最早的诊断日期被指定为索引日期),在其预索引基线期间至少连续入组 6 个月,并且在索引日期前后 ±90 天内至少有 1 次胰岛素或胰岛素泵的药房索赔。描述性总结了基线人口统计学和临床特征。评估了每位患者每月的平均 HCRU 和每月由健康计划和患者支付的费用(PPPM)。根据通货膨胀调整了费用,使其达到 2018 年的美元价值。我们在 MarketScan 中确定了 181423 名符合选择标准的 T1DM 患者,在 Optum EMR 中有 84759 名,在 Optum 综合数据库中有 8948 名。大多数患者为男性(各数据库范围:52.6%-53.1%),年龄相对较小(中位数:33-35 岁,总范围:0-100 岁),Charlson 合并症指数评分为 1(各数据库的 69.2%-73.0%)。在随访期间,所有原因和糖尿病相关的总费用分别为 1482 美元至 1522 美元和 733 美元至 780 美元/人/月。药房费用是护理总成本的主要组成部分,占糖尿病相关总费用的 55.3%(431 美元)至 61.1%(448 美元)。按年度计算,患者在随访期间平均每年有 0.2-0.9 次全因住院治疗和 0.1-0.3 次糖尿病相关住院治疗。每次糖尿病相关住院治疗的中位数费用从 6548 美元到 8439 美元不等,占每月糖尿病相关费用的 4%-7%。患者每年平均有 0.4-0.5 次全因和 0.1-0.2 次糖尿病相关急诊就诊;急诊就诊的中位数费用为 972 美元至 1499 美元,占随访期间每月糖尿病相关费用的 2%左右。在这项针对儿科和成年 T1DM 患者的大型回顾性观察性研究中,糖尿病相关费用总计近 800 美元/月。药房费用占糖尿病相关费用的一半以上,表明 T1DM 治疗的经济负担很大。需要进一步研究以确定与昂贵事件(如住院和急诊就诊)相关的风险因素以及与 T1DM 相关的间接费用。JDRF International 为该项目和手稿提供了资金。JDRF International 还与 Evidera(一家为生物制药行业提供研究和咨询服务的公司)合作参与该项目和本手稿的编写。Leona M. 和 Harry B. Helmsley 慈善信托基金为 JDRF International 提供了资金。Simeone、Shah 和 Ganz 受雇于 Evidera,并未从 Evidera 的客户那里直接获得任何报酬或酬金。LeGrand 是 JDRF International 的员工。Bushman 在研究和本手稿的编写期间受雇于 JDRF International。Sullivan 和 Koralova 是 Leona M. 和 Harry B. Helmsley 慈善信托基金的员工。