Dupenloup Paul, Zhou Margaret, Dizon Matthew P, Shah Aadit P, Goldhaber-Fiebert Jeremy D, Owens Douglas K, Streett Sarah E, Brandeau Margaret L, Barber Grant E
Department of Management Science and Engineering, Huang Engineering Center, Stanford University, 475 Via Ortega, Mail Code: 4026, Stanford, CA, 94305, USA.
Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA.
Dig Dis Sci. 2025 Feb;70(2):728-737. doi: 10.1007/s10620-024-08802-1. Epub 2024 Dec 26.
Ulcerative colitis (UC) can be treated with infliximab (IFX). Therapeutic drug monitoring (TDM) can yield superior outcomes, but its cost-effectiveness is unknown.
We used a decision analytic Markov model to conduct a cost-effectiveness analysis comparing proactive TDM, reactive TDM, no TDM, and combinations of proactive and reactive TDM in 25-year-old patients with UC started on IFX. Under proactive TDM, IFX concentration and anti-drug antibodies were measured every 6 months and during a flare; under reactive TDM, these were only measured during a flare. Patients with flares experienced decreased quality of life (QoL) and risked further complications. We evaluated lifetime costs (2021 U.S. dollars), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios, all discounted at 3% annually, from a healthcare sector perspective. We performed probabilistic sensitivity analysis (PSA) and deterministic sensitivity analyses. We used a willingness-to-pay threshold of $100,000 per QALY gained.
All TDM strategies increased QALYs and healthcare costs. Compared to no TDM, reactive TDM increased costs from $496,700 to $497,500 ($3,200 per QALY gained). 1 year of proactive TDM followed by reactive TDM increased costs to $508,600 ($63,800 per QALY gained relative to reactive TDM). In 46% of PSA samples, 1 year of proactive TDM followed by reactive TDM was most likely to be the optimal strategy. This strategy was less likely to be cost-effective when remission QoL was lower and when post-surgical QoL was higher.
1 year of proactive TDM followed by reactive TDM is cost-effective in patients with UC on IFX.
溃疡性结肠炎（UC）可用英夫利昔单抗（IFX）治疗。治疗药物监测（TDM）可产生更好的治疗效果，但其成本效益尚不清楚。
我们使用决策分析马尔可夫模型进行成本效益分析，比较在开始使用IFX的25岁UC患者中，主动TDM、被动TDM、不进行TDM以及主动与被动TDM联合使用的情况。在主动TDM方案下，每6个月以及病情发作期间测量IFX浓度和抗药抗体；在被动TDM方案下，仅在病情发作期间测量这些指标。病情发作的患者生活质量（QoL）下降，并有发生进一步并发症的风险。我们从医疗保健部门的角度评估了终身成本（2021年美元）、质量调整生命年（QALY）和增量成本效益比，所有数据均按每年3%进行贴现。我们进行了概率敏感性分析（PSA）和确定性敏感性分析。我们使用每获得一个QALY支付意愿阈值为100,000美元。
所有TDM策略均增加了QALY和医疗保健成本。与不进行TDM相比，被动TDM使成本从496,700美元增加到497,500美元（每获得一个QALY增加3,200美元）。先进行1年主动TDM然后进行被动TDM使成本增加到508,600美元（相对于被动TDM，每获得一个QALY增加63,800美元）。在46%的PSA样本中，先进行1年主动TDM然后进行被动TDM最有可能是最佳策略。当缓解期QoL较低且术后QoL较高时，该策略不太可能具有成本效益。
对于使用IFX治疗的UC患者，先进行1年主动TDM然后进行被动TDM具有成本效益。
