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* = Presenting author

P484 Access to biologics and biosimilars across 11 European Union countries

P. Lakatos*1, E. Domenech2, H. Kellner3, J. Marsal4, H. Fowler5, C. Agboton5, N. Georgitseas6, M. Cassese7, S. Anwar6, A. Venugopal7, P. Audhya5

1Semmelweis University, Budapest, Hungary, 2Hospital Universitari Germans Trias i Pujol., Badalona, Spain, 3Facharzt für Innere Medizin, Munich, Germany, 4Lund University, Lund, Sweden, 5Hospira, Warwickshire, United Kingdom, 6Navigant, London, United Kingdom, 7Navigant, New York, New York, United States


the study aim was to understand physician perspectives on the effect of guidelines, healthcare system cost burden, and patient out of pocket (OOP) cost on the decision to prescribe biologics and on the timing of biologic or biosimilar initiation.


In total, 220 gastroenterologists chosen randomly across 11 countries (Finland, France, Germany, Hungary, Ireland, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom) participated in a web-based survey from June to August 2015. Key eligibility criteria included being in a practice with at least 20% of patients with Crohn’s disease or 10% with ulcerative colitis; at least 10% of these treated with a biologic; infliximab prescribed (originator or biosimilar) to at least 1 patient; or access to biosimilar infliximab (able to prescribe Inflectra™ or Remsima™). Most (78%) had prescribed biosimilar infliximab to at least 1 patient.


Over 50% of physicians indicated that national or local guidelines, which specify the number of non-biologic therapies a patient must fail to be a candidate for biologic therapy, limit their ability to prescribe a biologic earlier. Two-thirds of physicians indicated that cost also affects the timing of biologic prescription, stating that an average of 37% of their UC and CD patients would have benefited from receiving a biologic sooner. Most physicians (85%) reported that the cost burden to their healthcare systems had at least some impact on their willingness to prescribe biologics. However, only 45% were aware of the actual costs of biologic agents in their countries. Similarly, despite a general lack of knowledge of the actual OOP per month for their patients, 55% of physicians stated that the direct OOP patient cost had at least some effect on their decision to prescribe a biologic. Half of physicians identified that the major advantage of biosimilar agents was the possibility to provide increased access to biologic therapy for their patients and treat patients at an earlier stage in their disease, largely driven by the lower cost of biosimilars.


Gastroenterologists surveyed across Europe who have access to biosimilar infliximab indicate that costs either to the healthcare system or to patients may represent non-clinical barriers to prescribing biologic therapy for their IBD patients. Biosimilars may represent an opportunity to overcome such prescribing constraints, with lower cost driving the potential for increased patient access, potentially at an earlier stage of disease. However, limited or incorrect awareness of the actual costs of biologic therapies may lessen demand for biosimilars.