从美国支付者角度评估托法替布治疗甲氨蝶呤或 1 或 2 种 TNF 抑制剂后类风湿关节炎的经济学评价。
An Economic Evaluation of Tofacitinib Treatment in Rheumatoid Arthritis After Methotrexate or After 1 or 2 TNF Inhibitors from a U.S. Payer Perspective.
机构信息
1 York Health Economics Consortium, University of York, United Kingdom.
2 Pfizer, Collegeville, Pennsylvania.
出版信息
J Manag Care Spec Pharm. 2018 Oct;24(10):1010-1017. doi: 10.18553/jmcp.2018.17220. Epub 2018 Jun 13.
BACKGROUND
Treatment cycling with biologic disease-modifying anti-rheumatic drugs, such as tumor necrosis factor inhibitors (TNFi), is common among patients with rheumatoid arthritis (RA) and can result in reduced clinical efficacy and increased economic burden. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA.
OBJECTIVE
To evaluate and compare the economic effect of tofacitinib 5 mg twice daily (BID) treatment directly after methotrexate (MTX) in the MTX-inadequate responder population, or after MTX and 1 TNFi (adalimumab [ADA] or etanercept [ETN]) or 2 TNFi (ADA and ETN) in TNF-inadequate responder patients with RA, from a U.S. payer perspective.
METHODS
A decision-tree economic model was used to evaluate costs over 2 years. Treatment response was modeled as American College of Rheumatology (ACR) 20/50/70 response. ACR response rates at 6-month intervals were derived from U.S. prescribing information for monotherapy and combination therapy. Safety event rates were sourced from a meta-analysis. It was assumed that 75% of patients switched therapy after an adverse event or lack of response. Cost inputs included drugs, monitoring and administration (including physician visits), health care utilization, and treatment for adverse events. The population comprised all organization members (i.e., RA and non-RA members); RA patients receiving TNFi were estimated using epidemiologic data. Results were based on an organization size of 1 million. Economic endpoints were total 2-year costs, costs per member per month (PMPM), and costs per ACR20/50 responder.
RESULTS
1,321 patients were included for analysis. Based on ACR20 switch criteria and either 100% or 50% monotherapy rates for all treatments, total 2-year costs and costs PMPM were lower for patients receiving tofacitinib as second-line therapy after MTX and as third-line therapy after MTX and 1 TNFi; costs were highest for patients who cycled through 2 TNFi. Similar trends were observed for switch criteria based on ACR50 response and addition of 20% rebates for ADA and ETN and 0% for tofacitinib, although differences were mitigated slightly.
CONCLUSIONS
A treatment strategy with tofacitinib as either second- or third-line therapy after MTX may be a lower cost treatment option, compared with fourth-line introduction of tofacitinib after cycling through 2 TNFi following MTX.
DISCLOSURES
All aspects of this study were funded by Pfizer. Claxton was an employee of York Health Economics Consortium, University of York, at the time of this study. Taylor is an employee of York Health Economics Consortium, The University of York, which received funding from Pfizer to conduct this study. Soonasra, Bourret, and Gerber are employees of Pfizer and hold stock/stock options in Pfizer. A previous iteration of the data reported in this manuscript (before adjustment for recent drug price increases) was presented at the Academy of Managed Care Pharmacy 28th Annual Meeting and Expo; April 19-22, 2016; held in San Francisco, CA.
背景
生物疾病修饰抗风湿药物(如肿瘤坏死因子抑制剂(TNFi))的治疗循环在类风湿关节炎(RA)患者中很常见,这可能导致临床疗效降低和经济负担增加。托法替尼是一种用于治疗 RA 的口服 Janus 激酶抑制剂。
目的
从美国支付者的角度评估和比较托法替尼 5mg 每日两次(BID)治疗在 MTX 应答不足患者中直接在 MTX 后或在 MTX 和 1 种 TNFi(阿达木单抗[ADA]或依那西普[ETN])或 2 种 TNFi(ADA 和 ETN)应答不足的 RA 患者中的经济效果。
方法
使用决策树经济模型评估 2 年的成本。治疗反应建模为美国风湿病学会(ACR)20/50/70 反应。6 个月间隔的 ACR 反应率来自美国单药和联合治疗的处方信息。安全性事件率源自荟萃分析。假设 75%的患者在出现不良事件或无反应后更换治疗。成本投入包括药物、监测和管理(包括医生就诊)、医疗保健利用和不良事件治疗。该人群包括所有组织成员(即 RA 和非 RA 成员);使用流行病学数据估计接受 TNFi 的 RA 患者。结果基于组织规模为 100 万。经济终点是 2 年总成本、每位成员每月的成本(PMPM)和每位 ACR20/50 应答者的成本。
结果
纳入了 1321 名患者进行分析。根据 ACR20 转换标准和所有治疗的 100%或 50%单药治疗率,与 MTX 后接受托法替尼作为二线治疗和 MTX 后接受托法替尼和 1 种 TNFi 作为三线治疗的患者相比,2 年总成本和 PMPM 较低;接受两种 TNFi 循环治疗的患者成本最高。基于 ACR50 反应的转换标准和 ADA 和 ETN 增加 20%的回扣以及托法替尼增加 0%的回扣,观察到类似的趋势,尽管差异略有缓解。
结论
与 MTX 后两种 TNFi 循环后引入托法替尼作为第四线治疗相比,托法替尼作为 MTX 后二线或三线治疗的治疗策略可能是成本较低的治疗选择。
披露
本研究的各个方面均由辉瑞公司资助。Claxton 在这项研究期间是约克大学卫生经济学联盟的员工。Taylor 是约克大学卫生经济学联盟的员工,该联盟接受辉瑞公司的资助进行这项研究。Soonasra、Bourret 和 Gerber 是辉瑞公司的员工,并持有辉瑞公司的股票/股票期权。本报告中报告的数据的先前版本(在调整最近的药物价格上涨之前)在第 28 届管理式医疗药房协会年度会议和博览会上提出;2016 年 4 月 19 日至 22 日;在加利福尼亚州旧金山举行。