Amgen, Thousand Oaks, California.
IBM Watson Health, Cambridge, Massachusetts.
J Manag Care Spec Pharm. 2020 Aug;26(8):1039-1049. doi: 10.18553/jmcp.2020.26.8.1039.
Targeted immunomodulators (TIMs) are used for the treatment of moderate to severe rheumatoid arthritis (RA) and include biologic and nonbiologic medications with different mechanisms of action. Data describing disease activity levels in RA are not directly available in claims databases but can be determined using a claims-based effectiveness algorithm. Rheumatology has benefited from the recent introduction of new drugs, many with new mechanisms of action. We provide an analysis of this broader range of medications.
To (a) describe and summarize the effectiveness of available TIMs for the treatment of moderate to severe RA and (b) determine the RA-related health care costs per effectively treated patient, using recent data.
This was a retrospective analysis using data from the IBM MarketScan Commercial Claims and Encounters Database from July 1, 2012, through December 31, 2016. Index date was the new prescription claim for a TIM (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, tocilizumab, or tofacitinib). A 6-month pre-index baseline period was used to determine demographic and clinical characteristics. Patients without a TIM claim during the baseline period were considered naive; patients with a TIM claim in the baseline period that was different than the index TIM were assessed as receiving second-line therapy. A claims-based algorithm was used to assess 12-month treatment effectiveness and total RA-related costs. Costs included RA-related pharmacy costs and medical costs.
Data from 14,775 patients were analyzed, including patients prescribed abatacept (n = 1,250), adalimumab (n = 4,986), certolizumab pegol (n = 387), etanercept (n = 5,266), golimumab (n = 577), infliximab (n = 969), tocilizumab (n = 451), and tofacitinib (n = 889). Of these, 705 were receiving second-line therapy. TIM effectiveness by first-line and second-line therapy, respectively, were abatacept 27.1%, 18.1%; adalimumab 30.9%, 22.1%; certolizumab pegol 20.9%, 14.3%; etanercept 31.4%, 31.5%; golimumab 32.7%, 22.2%; infliximab 21.9%, 21.3%; tocilizumab 30.9%, 30.6%; and tofacitinib 26.0%, 21.6%. The main reason for failing effectiveness was not achieving an 80% medication possession ratio or being nonadherent. The 1-year total RA-related cost per effectively treated patient for first-line and second-line therapies, respectively, were abatacept $121,835, $174,090; adalimumab $112,708, $154,540; certolizumab pegol $149,946, $236,743; etanercept $102,058, $94,821; golimumab $108,802, $140,651; infliximab $155,123, $185,369; tocilizumab $93,333, $109,351; and tofacitinib $100,306, $130,501.
The effectiveness of TIMs from this real-world experience showed that the range of patients who were effectively treated with first-line therapy was higher for certain tumor necrosis factor inhibitors and tocilizumab. The percentages of effectively treated patients were generally lower in second-line treatment compared with first-line except for etanercept, which had the same percentage between lines of therapy. Etanercept had the lowest RA-related cost per effectively treated patient among tumor necrosis factor inhibitors in first-line use and the lowest RA-related cost per effectively treated patient compared with all second-line treatments.
This study was sponsored by Amgen. Amgen employees contributed to study design, analysis of the data, and the decision to publish the results. Maksabedian Hernandez and Stolshek are employees and shareholders of Amgen; Gharaibeh was employed by Amgen at the time of this study. Bonafede was employed by IBM Watson Health, at the time of this study, and McMorrow is employed by IBM Watson Health, which received funding from Amgen to conduct this study. Data from this study were presented at AMCP Nexus, October 22-25, 2018, in Orlando, FL.
靶向免疫调节剂(TIMs)用于治疗中度至重度类风湿关节炎(RA),包括具有不同作用机制的生物制剂和非生物制剂药物。在索赔数据库中没有直接提供描述 RA 疾病活动水平的数据,但可以使用基于索赔的有效性算法来确定。风湿病受益于新型药物的最近推出,其中许多药物具有新的作用机制。我们对更广泛的药物进行了分析。
(a)描述和总结中度至重度 RA 治疗中可用 TIM 的有效性,(b)使用最新数据确定每有效治疗患者的 RA 相关医疗费用。
这是一项使用 IBM MarketScan 商业索赔和就诊数据库中 2012 年 7 月 1 日至 2016 年 12 月 31 日的数据进行的回顾性分析。索引日期为 TIM(阿巴西普、阿达木单抗、certolizumab pegol、依那西普、戈利木单抗、英夫利昔单抗、托珠单抗或托法替布)的新处方申请。使用 6 个月的索引前基线期来确定人口统计学和临床特征。在基线期没有 TIM 索赔的患者被认为是初治患者;在基线期有 TIM 索赔但与索引 TIM 不同的患者被评估为接受二线治疗。使用基于索赔的算法评估 12 个月的治疗效果和 RA 相关总成本。成本包括 RA 相关的药房成本和医疗成本。
对 14775 名患者的数据进行了分析,包括接受阿巴西普(n=1250)、阿达木单抗(n=4986)、certolizumab pegol(n=387)、依那西普(n=5266)、戈利木单抗(n=577)、英夫利昔单抗(n=969)、托珠单抗(n=451)和托法替布(n=889)的患者。其中,705 名患者接受二线治疗。一线和二线治疗的 TIM 有效性分别为阿巴西普 27.1%、18.1%;阿达木单抗 30.9%、22.1%;certolizumab pegol 20.9%、14.3%;依那西普 31.4%、31.5%;戈利木单抗 32.7%、22.2%;英夫利昔单抗 21.9%、21.3%;托珠单抗 30.9%、30.6%;托法替布 26.0%、21.6%。失效的主要原因是未达到 80%的药物持有率或不遵守用药方案。一线和二线治疗每有效治疗患者的 1 年 RA 相关总成本分别为阿巴西普 121835 美元、174090 美元;阿达木单抗 112708 美元、154540 美元;certolizumab pegol 149946 美元、236743 美元;依那西普 102058 美元、94821 美元;戈利木单抗 108802 美元、140651 美元;英夫利昔单抗 155123 美元、185369 美元;托珠单抗 93333 美元、109351 美元;托法替布 100306 美元、130501 美元。
从真实世界的经验来看,TIM 的有效性表明,某些肿瘤坏死因子抑制剂和托珠单抗治疗的有效治疗患者范围更高。与一线治疗相比,二线治疗的有效治疗患者百分比通常较低,除了依那西普,二线治疗的有效治疗患者百分比与一线治疗相同。在一线使用肿瘤坏死因子抑制剂中,依那西普每有效治疗患者的 RA 相关成本最低,与所有二线治疗相比,每有效治疗患者的 RA 相关成本也最低。
本研究由安进公司赞助。安进员工参与了研究设计、数据分析和发布结果的决策。Maksabedian Hernandez 和 Stolshek 是安进的员工和股东;Gharaibeh 在研究期间受雇于安进。Bonafede 在研究期间受雇于 IBM Watson Health,而 McMorrow 受雇于 IBM Watson Health,该公司从安进获得资金进行这项研究。本研究的部分数据在 2018 年 10 月 22 日至 25 日于佛罗里达州奥兰多举行的 AMCP Nexus 会议上进行了介绍。