University of Alabama at Birmingham, 510 20th Street South, Birmingham, AL, 35294, USA.
UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, USA.
Arthritis Res Ther. 2019 Dec 12;21(1):285. doi: 10.1186/s13075-019-2022-8.
Biosimilar infliximab has the potential for appreciable cost savings compared to its reference biologic, but dose escalation is common and increases costs. We compared frequency of dose escalation and associated Medicare-approved amount so as to determine the break-even point at which infliximab dose escalation would offset the cost savings of using a biosimilar, referent to alternatively using golimumab.
We studied Medicare enrollees with rheumatoid arthritis (RA) initiating infliximab or golimumab. Frequency of dose escalation was summarized descriptively over 18 months, as were Medicare-approved amounts for reimbursement. Analyses were repeated conditioning on high adherence (i.e., non-discontinuation, > 10-week gap). Multivariable-adjusted logistic regression and mixed models evaluated factors associated with infliximab dose escalation.
A total of 5174 infliximab and 2843 golimumab initiators were observed. Dose escalation was rare for golimumab (5%) but common for infliximab (49%), and was even more common (72%) for infliximab among patients who persisted on treatment. Regardless of dose escalation, the adjusted least square mean dollar amounts were appreciably higher for golimumab ($28,146) than for infliximab ($21,216) and greater among persistent patients (cost difference $9269, favoring infliximab). Only when patients escalated infliximab to ≥ 8 mg/kg every 6 weeks was golimumab IV at break-even or less expensive. After controlling for multiple factors, physician ownership of the infusion center was associated with greater likelihood of infliximab dose escalation (odds ratio = 1.25, 95% CI 1.09-1.44).
Despite frequent dose escalation with infliximab that often increase its dose by threefold or more, the savings from the current price of its biosimilar substantially offsets the costs of an alternative infused TNFi biologic for which no biosimilar is available.
与参照生物制剂相比，生物类似物英夫利昔单抗具有显著的成本节约潜力，但剂量升级很常见，且会增加成本。我们比较了剂量升级的频率和医疗保险批准的金额，以确定英夫利昔单抗剂量升级抵消使用生物类似物（相对于使用戈利木单抗）成本节约的平衡点。
我们研究了开始使用英夫利昔单抗或戈利木单抗的类风湿关节炎（RA）医疗保险参保者。18 个月内描述性总结剂量升级的频率，以及医疗保险报销的批准金额。在高依从性（即不中断，>10 周间隔）的情况下重复分析。多变量调整后的逻辑回归和混合模型评估了与英夫利昔单抗剂量升级相关的因素。
共观察到 5174 例英夫利昔单抗和 2843 例戈利木单抗起始患者。戈利木单抗的剂量升级很少（5%），但英夫利昔单抗的剂量升级很常见（49%），在持续治疗的患者中更为常见（72%）。无论是否进行剂量升级，调整后的最小平方均美元金额对于戈利木单抗（$28146）明显高于英夫利昔单抗（$21216），且在持续治疗的患者中更高（成本差异$9269，有利于英夫利昔单抗）。只有当患者将英夫利昔单抗升级为每 6 周≥8mg/kg 时，戈利木单抗 IV 才具有成本效益或更便宜。在控制多种因素后，医生拥有输液中心与英夫利昔单抗剂量升级的可能性更大相关（优势比=1.25，95%CI 1.09-1.44）。
尽管英夫利昔单抗频繁进行剂量升级，其剂量通常增加两倍或更多，但当前其生物类似物的价格节约大大抵消了没有生物类似物的替代输注 TNFi 生物制剂的成本。
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