Zhu Julia, Ayer Gretchen, Kirkham Heather S, Chen Chi-Chang, Wade Rolin L, Karkare Swapna U, Robson Chester H, Orange Jordan S
Health Analytics, Research and Reporting, Walgreen Co., Deerfield, IL, USA.
Business Development, Option Care Inc., Bannockburn, IL, USA.
J Res Pharm Pract. 2019 Apr-Jun;8(2):52-63. doi: 10.4103/jrpp.JRPP_18_36.
The aim of this study is to compare clinical and cost outcomes of patients undergoing subcutaneous immunoglobulin (SCIG) therapy who were managed by a clinical management program to the matched controls in the United States.
This was a retrospective cohort study using administrative claims data from the PharMetrics Plus™ (PMTX+) database. The patients from a high-touch SCIG clinical management program were matched to nonprogram patients in PMTX+ database using 1:4 propensity score matching without replacement. All patients were followed for 1 year during the study from September 1, 2011, to June 30, 2014, and both clinical and cost outcomes were compared between the two cohorts using the generalized estimating equation model.
The clinical outcomes were measured by infection- and infusion-related adverse events (AEs). Most of them were not significantly different ( > 0.05) between the intervention group and matched controls. Although the proportion of patients who had a mild less common AE was higher (4.4% vs. 0.0%;P = 0.04), it could be due to increased reporting among the intervention group. The annual adjusted mean total health-care costs of patients in the program ( = 45) were $20,868 lower compared to matched controls ( = 180), representing a 24% lower costs ($66,450 vs. $87,318;P = 0.009).
This study may demonstrate that clinical management programs for SCIG may be associated with lower health-care costs and comparable infection and severe AE rates. The limitations of this study included a small sample size and a reliance on administrative claim data.
本研究旨在比较接受皮下免疫球蛋白（SCIG）治疗并由临床管理项目管理的患者与美国匹配对照组的临床和成本结果。
这是一项回顾性队列研究，使用来自PharMetrics Plus™（PMTX+）数据库的行政索赔数据。来自高接触性SCIG临床管理项目的患者与PMTX+数据库中的非项目患者使用1:4倾向得分匹配且无替换。在2011年9月1日至2014年6月30日的研究期间，对所有患者随访1年，并使用广义估计方程模型比较两组的临床和成本结果。
临床结果通过感染和输注相关不良事件（AE）进行衡量。干预组和匹配对照组之间的大多数结果无显著差异（>0.05）。虽然发生轻度罕见AE的患者比例在干预组中更高（4.4%对0.0%；P = 0.04），但这可能是由于干预组报告增加所致。项目组患者（n = 45）的年度调整后平均总医疗费用比匹配对照组（n = 180）低20,868美元，成本降低了24%（66,450美元对87,318美元；P = 0.009）。
本研究可能表明，SCIG临床管理项目可能与较低的医疗成本以及相当的感染和严重AE发生率相关。本研究的局限性包括样本量小和依赖行政索赔数据。
