Department of Health Economics, Corvinus University of Budapest, Fővám tér 8, Budapest, 1093, Hungary,
Eur J Health Econ. 2014 May;15 Suppl 1(Suppl 1):S65-71. doi: 10.1007/s10198-014-0595-3. Epub 2014 May 16.
The first biosimilar monoclonal antibody (infliximab, CT-P13) was registered by the European Medicines Agency in 2013 for the treatment of several inflammatory conditions including rheumatoid arthritis (RA). Biosimilar infliximab is first being marketed in the Central and Eastern European countries. This paper presents the estimated budget impact of the introduction of biosimilar infliximab in RA over a 3-year time period in six selected countries, namely Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. A prevalence-based model was constructed for budget impact analysis. Two scenarios were compared to the reference scenario (RSc) where no biosimilar infliximab is available: biosimilar scenario 1 (BSc1), where interchanging the originator infliximab with biosimilar infliximab is disallowed, and only patients who start new biological therapy are allowed to use biosimilar infliximab; as well as biosimilar scenario 2 (BSc2), where interchanging the originator infliximab with biosimilar infliximab is allowed, and 80% of patients treated with originator infliximab are interchanged to biosimilar infliximab. Compared to the RSc, the net savings are estimated to be €15.3 or €20.8 M in BSc1 and BSc2, respectively, over the 3 years. If budget savings were spent on reimbursement of additional biosimilar infliximab treatment, approximately 1,200 or 1,800 more patients could be treated in the six countries within 3 years in the two biosimilar scenarios, respectively. The actual saving is most sensitive to the assumption of the acquisition cost of the biosimilar drug and to the initial number of patients treated with biological therapy. The study focused on one indication (RA) and demonstrated that the introduction of biosimilar infliximab can lead to substantial budget savings in health care budgets. Further savings are expected for other indications where biosimilar medicines are implemented.
首个生物类似药（英夫利昔单抗，CT-P13）于 2013 年在欧洲药品管理局注册，用于治疗包括类风湿关节炎（RA）在内的多种炎症性疾病。生物类似药英夫利昔单抗首先在中东欧国家上市。本文介绍了在 6 个选定国家（保加利亚、捷克共和国、匈牙利、波兰、罗马尼亚和斯洛伐克），RA 患者在 3 年内使用生物类似药英夫利昔单抗的预计预算影响。采用基于患病率的模型进行预算影响分析。将两种方案与不使用生物类似药英夫利昔单抗的参照方案（RSc）进行比较：方案 1（BSc1），不允许将原研英夫利昔单抗与生物类似药英夫利昔单抗相互转换，只有开始新的生物治疗的患者才能使用生物类似药英夫利昔单抗；以及方案 2（BSc2），允许将原研英夫利昔单抗与生物类似药英夫利昔单抗相互转换，80%用原研英夫利昔单抗治疗的患者转换为生物类似药英夫利昔单抗。与 RSc 相比，BSc1 和 BSc2 在 3 年内的净节省估计分别为 1530 万欧元或 2080 万欧元。如果节省的预算用于支付额外的生物类似药英夫利昔单抗治疗费用，那么在这两种生物类似药方案中，6 个国家在 3 年内可以多治疗约 1200 或 1800 名患者。实际节省额最敏感于生物类似药药物的采购成本假设和开始用生物疗法治疗的患者数量假设。本研究仅关注一种适应症（RA），并表明生物类似药英夫利昔单抗的引入可以导致医疗保健预算的大量节省。在实施生物类似药的其他适应症中，预计会有进一步的节省。
