Gulati Ankit, Mittal Neha, Kane Sunanda, Creveling Thomas, Bires Nicholas, Fisher Deborah A, Chanan Neha, Koushik Amit Kumar, Upadhyay Navneet
Eli Lilly and Company, Indianapolis, IN, USA.
Department of Gastroenterology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.
J Med Econ. 2025 Dec;28(1):709-718. doi: 10.1080/13696998.2025.2503661. Epub 2025 May 15.
Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.
An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.
The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).
Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.
已获批用于治疗中度至重度活动性溃疡性结肠炎（UC）的mirikizumab，在二线治疗中，其处方位置可能与优特克单抗类似。医保支付方在做出医保药品目录决策时可能会比较其经济价值。本研究估算并比较了UC患者二线治疗中mirikizumab与优特克单抗实现缓解的成本。
从美国商业医保支付方的角度出发，开发了一个基于Excel的分析模型，以估算在接受过生物制剂/Janus激酶抑制剂（JAKi）治疗的UC患者（二线治疗）中，在一年结束时每增加一名实现临床缓解的患者的成本。对已发表的关键随机临床试验进行网络荟萃分析，以得出研究人群中优特克单抗和mirikizumab实现临床反应、临床缓解以及内镜缓解/内镜改善/黏膜愈合所需的治疗人数（NNT）。该模型包括诱导期和维持期的治疗成本（批发采购成本[WAC]和治疗管理成本）。还评估了一种涉及优特克单抗生物类似药可用性的情景，假设NNT与优特克单抗相同，但WAC设定为比其当前WAC低50%。
作为二线治疗，mirikizumab与优特克单抗相比，实现临床缓解的每位患者在诱导期的成本分别为461,096美元和67,273美元，在维持期分别为501,456美元和1,079,189美元。在维持期剂量增加的情况下，mirikizumab实现临床缓解的成本低于优特克单抗（501,456美元对1,569,127美元）。考虑到优特克单抗130mg静脉注射生物类似药，该情景下mirikizumab在维持期实现临床缓解的成本低于优特克单抗生物类似药（501,456美元对539,594美元）。
预计mirikizumab在维持治疗期间每实现一次缓解的成本低于优特克单抗。鉴于这种慢性病需要长期治疗，mirikizumab似乎是一种具有成本效益的治疗选择。
