University of Washington, Box 357630, Seattle, WA 98195.
J Manag Care Spec Pharm. 2015 Jan;21(1):37-44, 44a-d. doi: 10.18553/jmcp.2015.21.1.37.
Pazopanib was noninferior to sunitinib in progression-free survival in a phase III, open-label, randomized clinical trial comparing the efficacy and safety of the 2 drugs for treatment of patients with advanced renal cell carcinoma (RCC). A secondary analysis of this trial conducted on patient-reported health care resource utilization (HCRU) endpoints revealed significantly fewer monthly telephone consultations and emergency department visits among patients treated with pazopanib over the first 6 months of treatment.
To (a) compare total costs of HCRU and adverse events (AEs) in patients with advanced RCC receiving first-line pazopanib or sunitinib from the phase III clinical trial and (b) perform a post hoc economic analysis that applied direct medical care and pharmacy unit costs, obtained from the Truven Health MarketScan Databases, to HCRU and AE rates.
Total HCRU costs included components for provider contacts, diagnostics, hospitalizations, procedures, and study/nonstudy drugs. Patients were stratified by the presence or absence of an AE in order to estimate costs attributable to AEs. Costs were adjusted to 2013 U.S. dollars. The highest 1% of cost outliers were equally excluded from each group. Univariate (t-test and Kaplan-Meier sample average [KMSA]) and multivariate (using treatment group and region as covariates) analyses were performed.
A total of 906 patients (pazopanib, n = 454; sunitinib, n = 452) reported HCRU; higher rates were observed for sunitinib. In unadjusted cost analyses, the mean total costs for pazopanib-treated patients were 8.0% lower than those treated with sunitinib ($80,464 vs. $86,886; P = 0.20). The difference in KMSA-estimated costs was significantly higher for sunitinib versus pazopanib ($156,128 vs. $143,585; P = 0.003). Adjusted cost differences between arms consistently suggested higher costs for sunitinib. Among patients who experienced greater than or equal to 1 AE, costs were $8,118 higher for pazopanib-treated patients and $14,343 for sunitinib-treated patients.
The findings suggest that health care costs were lower among patients with advanced RCC treated first-line with pazopanib versus sunitinib.
在一项比较两种药物治疗晚期肾细胞癌(RCC)患者疗效和安全性的 III 期、开放标签、随机临床试验中,帕唑帕尼在无进展生存期方面不劣于舒尼替尼。该试验的一项患者报告的卫生保健资源利用(HCRU)终点的二次分析显示,接受帕唑帕尼治疗的患者在治疗的前 6 个月内每月电话咨询和急诊就诊次数明显减少。
(a)比较接受一线帕唑帕尼或舒尼替尼治疗的晚期 RCC 患者的 HCRU 和不良事件(AE)的总费用,(b)对应用来自 Truven Health MarketScan 数据库的直接医疗和药房单位成本对 HCRU 和 AE 率进行事后经济分析。
总 HCRU 成本包括与提供者接触、诊断、住院、手术和研究/非研究药物相关的部分。根据是否存在 AE 对患者进行分层,以估计 AE 导致的成本。成本调整为 2013 年美元。从每组中均等排除最高 1%的成本异常值。进行了单变量(t 检验和 Kaplan-Meier 样本平均 [KMSA])和多变量(使用治疗组和地区作为协变量)分析。
共有 906 名患者(帕唑帕尼组,n=454;舒尼替尼组,n=452)报告了 HCRU;舒尼替尼组的报告率较高。在未调整的成本分析中,接受帕唑帕尼治疗的患者的平均总费用比接受舒尼替尼治疗的患者低 8.0%(80464 美元 vs. 86886 美元;P=0.20)。KMSA 估计成本的差异在舒尼替尼与帕唑帕尼之间显著更高(156128 美元 vs. 143585 美元;P=0.003)。手臂之间的调整成本差异一致表明舒尼替尼的成本更高。在经历了 1 次或多次 AE 的患者中,接受帕唑帕尼治疗的患者的费用比接受舒尼替尼治疗的患者高 8118 美元,接受舒尼替尼治疗的患者的费用比接受舒尼替尼治疗的患者高 14343 美元。
研究结果表明,与接受舒尼替尼治疗的患者相比,接受一线帕唑帕尼治疗的晚期 RCC 患者的医疗保健费用更低。