IQVIA, 1 IMS Drive, Plymouth Meeting, PA, 19462, USA.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Pharmacoeconomics. 2020 Jan;38(1):39-56. doi: 10.1007/s40273-019-00829-x.
BACKGROUND/OBJECTIVE: Baricitinib is a selective and reversible Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitors (TNFis) and has been shown to improve multiple clinical and patient-reported outcomes. However, it is unclear what the budgetary impact would be for US commercial payers to add baricitinib to their formulary and how the efficacy of baricitinib compares to other disease-modifying antirheumatic drugs (DMARDs) with a similar indication.
A budget impact model (BIM) was developed for a hypothetical population of 1 million plan members that compared a world without and with baricitinib. A retrospective observational study was carried out to estimate market utilization of advanced therapies. Number needed to treat (NNT) and cost per additional responder were calculated for American College of Rheumatology (ACR) 20%/50%/70% improvement criteria (ACR20/50/70) response outcomes combining cost estimates from the BIM and efficacy values from a network meta-analysis (NMA). The model included costs related to drug acquisition and monitoring costs.
Adding baricitinib would save a commercial payer $US169,742 for second-line therapy and $US135,471 for third-line therapy over a 2-year time horizon (all costs correspond to 2019 US dollars). Cost savings were driven by baricitinib drawing market share away from more expensive comparators. The NMA, based on nine studies, found no statistically significant differences in the median treatment difference between baricitinib and comparators except for versus a conventional synthetic DMARD (csDMARD), and thus NNT versus a csDMARD was similar. The cost per additional responder for baricitinib in patients with inadequate response to a TNFi was substantially lower than all other treatments for all three ACR response criteria at 12 weeks (ACR20: $US129,672; ACR50: $US237,732; ACR70: $US475,464), and among the lowest at 24 weeks (ACR20: $US167,811; ACR50: $US259,344; ACR70: $US570,557).
Baricitinib, compared to other DMARDs, was a less expensive option (- $US0.01 incremental cost per member per month in second- and third-line therapy over a 2-year time horizon) with comparable efficacy in patients with inadequate response to TNFi. Adding baricitinib to formulary would likely be cost saving for US payers and expands treatment options for these patients.
背景/目的：巴利昔替尼是一种选择性和可逆的 Janus 激酶（JAK）抑制剂，适用于治疗对一种或多种肿瘤坏死因子抑制剂（TNFis）反应不足的中度至重度活跃类风湿关节炎（RA）的成年患者，并且已显示可改善多种临床和患者报告的结果。然而，尚不清楚美国商业支付者将巴利昔替尼纳入其处方集的预算影响有多大，以及巴利昔替尼的疗效与其他具有类似适应症的疾病修饰抗风湿药物（DMARDs）相比如何。
为一个拥有 100 万计划成员的假设人群开发了一个预算影响模型（BIM），该模型比较了没有和有巴利昔替尼的世界。进行了一项回顾性观察性研究，以估计先进疗法的市场利用情况。根据美国风湿病学会（ACR）20%/50%/70%改善标准（ACR20/50/70）的反应结果，计算了需要治疗的人数（NNT）和每个额外应答者的成本，这些结果结合了 BIM 的成本估算和网络荟萃分析（NMA）的疗效值。该模型包括与药物获取和监测成本相关的成本。
在两年的时间内，为二线治疗节省了 169742 美元，为三线治疗节省了 135471 美元（所有成本均对应 2019 年美元）。节省成本的原因是巴利昔替尼从更昂贵的对照药物中获得了市场份额。基于九项研究的 NMA 发现，巴利昔替尼与对照药物之间的中位治疗差异除了与常规合成 DMARD（csDMARD）相比外，没有统计学意义，因此与 csDMARD 相比，NNT 相似。在对 TNFis 反应不足的患者中，巴利昔替尼的额外应答者的成本与所有其他治疗方法相比，在 12 周时（ACR20：129672 美元；ACR50：237732 美元；ACR70：475464 美元）均较低，在 24 周时（ACR20：167811 美元；ACR50：259344 美元；ACR70：570557 美元）均较低。
与其他 DMARDs 相比，巴利昔替尼在二线和三线治疗的每个成员每月的增量成本为 -0.01 美元（在两年的时间内），在对 TNFis 反应不足的患者中具有可比的疗效。为患者增加巴利昔替尼可能会为美国支付者节省成本，并为这些患者扩大治疗选择。
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