Division of Gastroenterology, Mayo Clinic, Jacksonville, FL, USA.
Analysis Group, Inc., 1190 Avenue Des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada.
Adv Ther. 2024 Jun;41(6):2253-2266. doi: 10.1007/s12325-024-02832-x. Epub 2024 Apr 15.
Objective assessment of treatment effectiveness using real-world claims data is challenging. This study assessed treatment-free intervals (TFI) as a proxy for treatment effectiveness, and all-cause healthcare costs among adult patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin or eluxadoline in the USA.
Adult patients (18-64 years) with IBS-D and ≥ 1 rifaximin or eluxadoline prescription were identified in the IQVIA PharMetrics Plus database (10/01/2015-12/31/2021) and classified into two mutually exclusive cohorts (i.e., rifaximin and eluxadoline). Index date was the date of rifaximin or eluxadoline initiation. Entropy-balanced baseline characteristics, TFI (periods of ≥ 30 consecutive days without IBS-D treatment), and healthcare costs were reported. Healthcare costs were compared between cohorts using mean cost differences.
There were 7094 and 2161 patients in the rifaximin and eluxadoline cohorts, respectively. After balancing, baseline characteristics (mean age 44.1 years; female 72.4%) were similar between cohorts. A higher proportion of patients treated with rifaximin achieved a TFI of ≥ 30 days (76.2% vs. 66.7%), ≥ 60 days (67.0% vs. 47.0%), ≥ 90 days (61.0% vs. 38.7%), ≥ 180 days (51.7% vs. 31.0%), and ≥ 240 days (47.7% vs. 27.9%) compared to eluxadoline. Among patients with a TFI ≥ 30 days, mean TFI durations were 8.3 and 6.0 months for the rifaximin and eluxadoline cohorts. Mean all-cause healthcare costs were lower for rifaximin vs. eluxadoline ($18,316 vs. $23,437; p = 0.008), primarily driven by pharmacy costs ($7348 vs. $10,250; p < 0.001). In a simulated health plan of one million commercially insured lives, initiating 50% of patients on rifaximin instead of eluxadoline resulted in total cost savings of $2.1 million per year or $0.18 per-member-per-month.
This real-world study suggests that TFI is a meaningful surrogate measure of treatment effectiveness in IBS-D. Patients treated with rifaximin had longer treatment-free periods and lower healthcare costs than patients treated with eluxadoline.
使用真实世界的索赔数据客观评估治疗效果具有挑战性。本研究评估了治疗无间隔期（TFI）作为治疗效果的替代指标，以及接受利福昔明或鲁比前列酮治疗的美国腹泻型肠易激综合征（IBS-D）成年患者的全因医疗保健成本。
在 IQVIA PharMetrics Plus 数据库（2015 年 10 月 1 日至 2021 年 12 月 31 日）中确定了≥1 次利福昔明或鲁比前列酮处方的 18-64 岁 IBS-D 成年患者，并将其分为两个相互排斥的队列（即利福昔明和鲁比前列酮）。索引日期为利福昔明或鲁比前列酮起始日期。报告了平衡后的基线特征、TFI（≥30 天无 IBS-D 治疗的时间段）和医疗保健成本。使用平均成本差异比较队列之间的医疗保健成本。
利福昔明和鲁比前列酮队列分别有 7094 名和 2161 名患者。平衡后，队列间的基线特征（平均年龄 44.1 岁；女性 72.4%）相似。接受利福昔明治疗的患者有更高比例达到 TFI≥30 天（76.2%比 66.7%）、≥60 天（67.0%比 47.0%）、≥90 天（61.0%比 38.7%）、≥180 天（51.7%比 31.0%）和≥240 天（47.7%比 27.9%）。在 TFI≥30 天的患者中，利福昔明和鲁比前列酮队列的 TFI 持续时间分别为 8.3 个月和 6.0 个月。与鲁比前列酮相比，利福昔明的全因医疗保健成本较低（18316 美元比 23437 美元；p=0.008），主要原因是药房成本（7348 美元比 10250 美元；p<0.001）。在一个拥有 100 万商业保险的人群中，50%的患者开始使用利福昔明而非鲁比前列酮，每年可节省 210 万美元的总成本，或每人每月节省 0.18 美元。
本真实世界研究表明，TFI 是 IBS-D 治疗效果的有意义的替代指标。接受利福昔明治疗的患者的治疗无间隔期比接受鲁比前列酮治疗的患者更长，医疗保健成本更低。
