Kanters Tim A, Stevanovic Jelena, Huys Isabelle, Vulto Arnold G, Simoens Steven
Institute for Medical Technology Assessment, Institute of Health Policy and Management, Erasmus University RotterdamRotterdam, Netherlands.
Department of Pharmaceutical and Pharmacological Sciences, KU LeuvenLeuven, Belgium.
Front Pharmacol. 2017 May 31;8:322. doi: 10.3389/fphar.2017.00322. eCollection 2017.
Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with biologics. This study aimed to investigate the budget impact of adopting biosimilar infliximab in five European countries, considering that the budget impact includes the adoption of biosimilar infliximab and the availability of biologic alternatives such as vedolizumab, biosimilar etanercept, biosimilar rituximab, and other relevant factors. An existing budget impact model was adapted to forecast the budget impact in the UK, Germany, France, Spain, and Italy. Epidemiological parameters were derived from published literature reviewed in July 2015. Current market shares of biologics were derived from Therapy Watch (2012/2013 data). Respondents in a Delphi panel, conducted in 2015 and consisting of several leading rheumatologists and gastroenterologists from different nationalities, were asked to forecast uptake of biosimilar infliximab and estimate the proportion of patients eligible for a particular type of biological treatment, including biosimilar infliximab. Scenario analyses assessed the influence of various factors, including price reductions, on the budget. Uptake of biosimilar infliximab was particularly expected for naïve patients; switching patients that already received other biologics was not expected much. Market shares after 5 years of biosimilar infliximab were ~2% in rheumatology in all five countries and in gastroenterology ranged from 4% in France to over 30% in Italy. Except for France, budgets were expected to decrease for rheumatologic diseases. For gastroenterology, budgets were expected to decrease in Spain and Italy. Budgets were expected to increase substantially in the UK and Germany, due to the introduction of vedolizumab in the studied period. In France, budget was expected to slightly increase for ankylosing spondylitis, Crohn's Disease, and ulcerative collitis. Savings in budget were expected in all countries, for all diseases, when larger price discounts on biosimilar infliximab were used. This study has shown that only when price reductions are large enough (i.e., 50% or more), physicians indicated that they will prescribe biosimilars. Policy makers should ensure substantial price reductions and stimulate physicians to use biosimilar products, to obtain savings in healthcare budgets.
引入生物类似药英夫利昔单抗用于治疗风湿病（类风湿性关节炎和强直性脊柱炎）以及炎症性肠病（克罗恩病和溃疡性结肠炎）可能会降低与生物制剂相关的治疗成本。本研究旨在调查在五个欧洲国家采用生物类似药英夫利昔单抗对预算的影响，考虑到预算影响包括生物类似药英夫利昔单抗的采用以及诸如维多珠单抗、生物类似药依那西普、生物类似药利妥昔单抗等生物制剂替代药物的可用性及其他相关因素。采用现有的预算影响模型来预测英国、德国、法国、西班牙和意大利的预算影响。流行病学参数源自2015年7月审查的已发表文献。生物制剂的当前市场份额源自《治疗观察》（2012/2013年数据）。2015年进行了一次德尔菲小组调查，小组成员包括来自不同国家的几位顶尖风湿病学家和胃肠病学家，他们被要求预测生物类似药英夫利昔单抗的采用情况，并估计符合特定类型生物治疗（包括生物类似药英夫利昔单抗）条件的患者比例。情景分析评估了包括降价在内的各种因素对预算的影响。预计初治患者对生物类似药英夫利昔单抗的采用率会特别高；预计已经接受其他生物制剂治疗的转换患者的采用率不会太高。在所有五个国家，生物类似药英夫利昔单抗在风湿病领域使用5年后的市场份额约为2%，在胃肠病学领域，法国为4%，意大利超过30%。除法国外，预计风湿病疾病的预算会减少。对于胃肠病学，预计西班牙和意大利的预算会减少。由于在研究期间引入了维多珠单抗，预计英国和德国的预算会大幅增加。在法国，预计强直性脊柱炎、克罗恩病和溃疡性结肠炎的预算会略有增加。当生物类似药英夫利昔单抗有更大幅度的价格折扣时，预计所有国家的所有疾病在预算方面都会节省开支。这项研究表明，只有当降价幅度足够大（即50%或更多）时，医生才表示会开生物类似药。政策制定者应确保大幅降价，并激励医生使用生物类似药产品，以节省医疗保健预算。
