Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA.
Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
JCO Oncol Pract. 2021 Aug;17(8):e1225-e1234. doi: 10.1200/OP.20.01092.
The costs associated with clinical trial enrollment remain uncertain. We hypothesized that trial participation is associated with decreased total direct medical costs to health care payers in metastatic non-small-cell lung cancer.
In this retrospective cohort study, we linked clinical data from electronic medical records to sociodemographic data from a cancer registry and claims data from Medicare and two private insurance plans. We used a difference-in-difference analysis to estimate mean per patient per month total direct medical costs for patients enrolled on a second-line (2L) trial versus patients receiving standard-of-care 2L systemic therapy.
Among 70 eligible patients, the difference-in-difference of mean per patient per month total direct medical costs between 2L trial participants and nonparticipants was -$6,663 ( = .01), for a mean savings of $45,308 per patient for the duration of 2L trial therapy. In a secondary analysis by primary insurance payer, this difference-in-difference was -$5,526 ( = .26) for patients with commercial insurance and -$7,432 ( = .01) for patients with Medicare.
Participation in a 2L trial was associated with a $6,663 per month cost savings to health care payers for the duration of trial participation. Further studies are necessary to elucidate differences in cost savings from trial participation for Medicare and commercial payers. If confirmed, these results support health care payer investment in programs to improve clinical trial access and enrollment.
临床试验入组相关成本仍不确定。我们假设,临床试验参与与转移性非小细胞肺癌患者的医疗支付方的总直接医疗成本降低有关。
在这项回顾性队列研究中,我们将电子病历中的临床数据与癌症登记处的社会人口统计学数据以及医疗保险和两份私人保险计划的索赔数据进行了关联。我们使用差异分析来估计接受二线(2L)试验的患者与接受标准二线系统治疗的患者每月每位患者的总直接医疗费用的平均值。
在 70 名符合条件的患者中,2L 试验参与者与非参与者每月每位患者的总直接医疗费用差异为 -$6,663( =.01),意味着每位患者在 2L 试验治疗期间节省了$45,308。在按主要保险支付人进行的二次分析中,商业保险患者的这一差异为 -$5,526( =.26),医疗保险患者为 -$7,432( =.01)。
在试验参与期间,医疗支付方每月可节省 6,663 美元的成本。需要进一步的研究来阐明医疗保险和商业支付者从试验参与中节省成本的差异。如果得到证实,这些结果支持医疗保健支付方投资于改善临床试验参与和招募的计划。