Jakovljevic Mihajlo, Gutzwiller Florian, Schwenkglenks Matthias, Milovanovic Olivera, Rancic Nemanja, Varjacic Mirjana, Stojadinovic Dobrivoje, Dagovic Aleksandar, Matter-Walstra Klazien
Department of Pharmacology and Toxicology, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia.
J BUON. 2014 Oct-Dec;19(4):1111-20.
To assess and compare the costs of first-line monoclonal antibodies (mAbs) treatment protocols in breast cancer, non-Hodgkin lymphoma and colorectal carcinoma in South-Eastern Europe.
A retrospective, bottom-up case series study design was implemented with one-year time horizon and payer's perspective. The study sample size was 265 patients (breast cancer, N=137; colorectal cancer, N=44; and non-Hodgkin lymphoma, N=84), while treatment protocols included adjuvant mAbs: trastuzumab (N=137), bevacizumab (N=28), rituximab (N=16) and cetuximab (N=84). ICD-10 related resources use included history of medical services utilization, chronology (time out of service provision) and unit consumption of examinations, drugs prescribed, imaging, radiotherapy and surgical procedures provided etc., direct medical and lost productivity costs (€) across treatment groups during 2010-2013.
The average length of observation was 125+97 days per patient. Total mean direct and indirect costs of care were: trastuzumab for breast cancer group € 17,740 per patient; bevacizumab for colorectal carcinoma group €8,775 per patient; cetuximab for colorectal carcinoma group € 27,181 per patient; and rituximab for non-Hodgkin lymphoma group €19,431 per patient. An average mAbs-treated patient incurred €17,897 costs of medical care. The total combined budget of these 330 patients was €4,742,775.
The use of mAbs strongly correlated with high costs in first-line cancer medical care and dominated other cost domains. Cetuximab-based treatment protocols in colorectal carcinoma patients was substantially more expensive compared to trastuzumab (C50), bevacizumab (C20), and rituximab (C80) alternatives. Extremely high costs of mAbs are the key-issue for Eastern European policy makers by crossing the upper limits of affordability in middle-income economies.
评估并比较东南欧乳腺癌、非霍奇金淋巴瘤和结直肠癌一线单克隆抗体（mAb）治疗方案的成本。
采用回顾性、自下而上的病例系列研究设计，以一年为时间范围，从支付方的角度进行研究。研究样本量为265例患者（乳腺癌，N = 137；结直肠癌，N = 44；非霍奇金淋巴瘤，N = 84），治疗方案包括辅助性mAb：曲妥珠单抗（N = 137）、贝伐单抗（N = 28）、利妥昔单抗（N = 16）和西妥昔单抗（N = 84）。与ICD - 10相关的资源使用情况包括医疗服务利用史、时间顺序（服务提供中断时间）以及检查、处方药物、影像学检查、放疗和手术操作等的单位消耗量等，2010 - 2013年各治疗组的直接医疗成本和生产力损失成本（欧元）。
每位患者的平均观察时长为125 + 97天。护理的总平均直接和间接成本分别为：乳腺癌组曲妥珠单抗每位患者17,740欧元；结直肠癌组贝伐单抗每位患者8,775欧元；结直肠癌组西妥昔单抗每位患者27,181欧元；非霍奇金淋巴瘤组利妥昔单抗每位患者19,431欧元。接受mAb治疗的患者平均医疗护理成本为17,897欧元。这330例患者的总预算为4,742,775欧元。
在一线癌症医疗护理中，mAb的使用与高成本密切相关，且在其他成本领域占主导地位。与曲妥珠单抗（C50）、贝伐单抗（C20）和利妥昔单抗（C80）相比，结直肠癌患者基于西妥昔单抗的治疗方案成本要高得多。mAb的极高成本跨越了中等收入经济体的可承受上限，这是东欧政策制定者面临的关键问题。
