BACKGROUND: This study aims to compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied. RESULTS: The bsIFX versus conventional therapy resulted in the most favourable incremental cost-utility ratios (ICURs) ranging from €34,580 (Hungary) to €77,062/QALY (Sweden). Compared to bsIFX, the bsIFX-ADA sequence was more cost-effective than the bsIFX-VEDO sequence with ICURs varying between €70,277 (France) and €162,069/QALY (Germany). The ICURs of the bsIFX-ADA-VEDO sequence versus the bsIFX-ADA strategy were between €206,266 (The Netherlands) and €363,232/QALY (Spain). CONCLUSION: We are the first to compare cost-effectiveness of multiple biological sequences for luminal Crohn's disease. Based on our findings, bsIFX can be recommended as a first-line treatment in patients unresponsive to conventional treatments. While biological sequences only slightly differ in their associated health gains, their costs vary greatly. The bsIFX-ADA-VEDO seems to be the most cost-effective sequence of the available biologics across Europe.

b 1st Department of Medicine Semmelweis University Budapest Hungary

c Department of Medicine 1 Agaplesion Markus Krankenhaus Frankfurt Germany

Department of Gastroenterology Faculty of Medicine and Health Örebro University Örebro Sweden

Department of Health Economics Corvinus University of Budapest Budapest Hungary

Department of Health Economics Corvinus University of Budapest Budapest Hungary f Center for Economic Research and Graduate Education Research Fellow Charles University Praha 1 The Czech Republic

e Gastroenterology Unit Clinical Universitary Hospital Lozano IIS Aragón Zaragoza Spain

g Inserm U954 and Department of Hepato Gastroenterology University Hospital of Nancy Brabois Lorraine University Vandoeuvre lès Nancy France

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$a Rencz, Fanni $u a Department of Health Economics , Corvinus University of Budapest , Budapest , Hungary.

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$a Cost-utility of biological treatment sequences for luminal Crohn's disease in Europe / $c F. Rencz, L. Gulácsi, M. Péntek, KB. Gecse, A. Dignass, J. Halfvarson, F. Gomollón, P. Baji, L. Peyrin-Biroulet, PL. Lakatos, V. Brodszky,

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$a BACKGROUND: This study aims to compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied. RESULTS: The bsIFX versus conventional therapy resulted in the most favourable incremental cost-utility ratios (ICURs) ranging from €34,580 (Hungary) to €77,062/QALY (Sweden). Compared to bsIFX, the bsIFX-ADA sequence was more cost-effective than the bsIFX-VEDO sequence with ICURs varying between €70,277 (France) and €162,069/QALY (Germany). The ICURs of the bsIFX-ADA-VEDO sequence versus the bsIFX-ADA strategy were between €206,266 (The Netherlands) and €363,232/QALY (Spain). CONCLUSION: We are the first to compare cost-effectiveness of multiple biological sequences for luminal Crohn's disease. Based on our findings, bsIFX can be recommended as a first-line treatment in patients unresponsive to conventional treatments. While biological sequences only slightly differ in their associated health gains, their costs vary greatly. The bsIFX-ADA-VEDO seems to be the most cost-effective sequence of the available biologics across Europe.

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$a Gulácsi, László $u a Department of Health Economics , Corvinus University of Budapest , Budapest , Hungary.

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$a Péntek, Márta $u a Department of Health Economics , Corvinus University of Budapest , Budapest , Hungary.

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$a Gecse, Krisztina B $u b 1st Department of Medicine , Semmelweis University , Budapest , Hungary.

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$a Dignass, Axel $u c Department of Medicine 1 , Agaplesion Markus Krankenhaus , Frankfurt , Germany.

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$a Halfvarson, Jonas $u d Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.

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$a Gomollón, Fernando $u e Gastroenterology Unit , Clinical Universitary Hospital Lozano IIS Aragón (Blesa, IIS Aragón, CIBEREHD) , Zaragoza , Spain.

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$a Baji, Petra $u a Department of Health Economics , Corvinus University of Budapest , Budapest , Hungary. f Center for Economic Research and Graduate Education (CERGE) Economics Institute (EI) Research Fellow , Charles University , Praha 1 , The Czech Republic.

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$a Peyrin-Biroulet, Laurent $u g Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy-Brabois , Lorraine University , Vandoeuvre-lès-Nancy , France.

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$a Lakatos, Peter L $u b 1st Department of Medicine , Semmelweis University , Budapest , Hungary.

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$a Brodszky, Valentin $u a Department of Health Economics , Corvinus University of Budapest , Budapest , Hungary.

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