Chaudhary Mohammad A, Fan Tao
Health Economic Statistics, Merck Research Labs, Mail Stop: UG-1C60, 351 N. Sumneytown Pike, North Wales, PA 19454-2505 USA.
Merck & Co., Inc., 1 Merck Drive, Whitehouse Station, NJ USA.
Biol Ther. 2013;3(1):45-60. doi: 10.1007/s13554-012-0007-0. Epub 2012 Dec 21.
Infliximab is registered for the treatment of moderate-to-severe active ulcerative colitis (UC) adult patients who have had an inadequate response, or are intolerant, or have medical contraindications to therapy including corticosteroids and 5-aminosalicylates or thiopurines (6-mercaptopurine [6-MP] or azathioprine [AZA]). The authors estimate the costs and effects and evaluate the cost-effectiveness of infliximab at the licensed dose of 5 mg/kg versus cyclosporine or surgery for the treatment of adult Dutch patients hospitalized with acute exacerbations of UC, refractory to intravenous steroids.
An existing decision analytical model was updated to simulate disease progression of hospitalized UC patients in the Netherlands, refractory to intravenous corticosteroids, and to estimate the costs and benefits associated with infliximab compared to cyclosporine and surgery over a 1-year time horizon. Colectomy rates were derived from infliximab and cyclosporine randomized trials and synthesized using multiple treatment comparison methods. The utility estimates associated with health states of ulcerative colitis patients were obtained from the literature. Resource use and drug use frequencies as well as unit costs were obtained from Dutch sources. The primary effectiveness measure used in the analysis was quality-adjusted life years (QALYs).
For a typical UC patient with body weight of 70 kg, the costs of treatment with infliximab, cyclosporine, and surgery over a 1-year treatment period were €17,062, €14,784, €13,979, respectively. The associated numbers of QALYs were 0.80, 0.70, and 0.58 for infliximab, cyclosporine, and surgery respectively. The incremental cost-effectiveness ratio for infliximab was €24,277 per QALY gained compared to cyclosporine, and €14,639 per QALY gained compared to surgery.
Infliximab induction regimen appears to be a cost-effective treatment option in comparison to cyclosporine and surgery for hospitalized patients with acute exacerbations of UC, refractory to intravenous corticosteroids in the Netherlands.
英夫利昔单抗已获批用于治疗中度至重度活动性溃疡性结肠炎(UC)成年患者,这些患者对包括皮质类固醇、5-氨基水杨酸酯或硫嘌呤(6-巯基嘌呤[6-MP]或硫唑嘌呤[AZA])在内的治疗反应不足、不耐受或存在医学禁忌。作者估计了成本和效果,并评估了英夫利昔单抗在5 mg/kg许可剂量下与环孢素或手术相比治疗因UC急性加重而住院、对静脉注射类固醇难治的成年荷兰患者的成本效益。
更新现有的决策分析模型,以模拟荷兰因静脉注射皮质类固醇难治的住院UC患者的疾病进展,并估计与英夫利昔单抗相比,环孢素和手术在1年时间范围内的成本和效益。结肠切除术发生率来自英夫利昔单抗和环孢素随机试验,并使用多种治疗比较方法进行综合分析。溃疡性结肠炎患者健康状态的效用估计值来自文献。资源使用和药物使用频率以及单位成本来自荷兰的资料来源。分析中使用的主要有效性指标是质量调整生命年(QALY)。
对于一名体重70 kg的典型UC患者,英夫利昔单抗、环孢素和手术在1年治疗期的治疗成本分别为17,062欧元、14,784欧元、13,979欧元。英夫利昔单抗、环孢素和手术分别对应的QALY数量为0.80、0.70和0.58。与环孢素相比,英夫利昔单抗每获得一个QALY的增量成本效益比为24,277欧元,与手术相比为14,639欧元。
在荷兰,对于因UC急性加重而住院、对静脉注射皮质类固醇难治的患者,与环孢素和手术相比,英夫利昔单抗诱导方案似乎是一种具有成本效益的治疗选择。