Biosimilars for the Management of Inflammatory Bowel Diseases: Economic Considerations

Author(s): Laszlo Gulacsi , Marta Pentek , Fanni Rencz , Valentin Brodszky , Petra Baji , Zsuzsanna Vegh , Krisztina B Gecse , Silvio Danese , Laurent Peyrin-Biroulet , Peter L. Lakatos* .

Journal Name: Current Medicinal Chemistry

Volume 26 , Issue 2 , 2019

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Abstract:

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant.

If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians’ and patients’ skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.

Keywords: Biosimilars, inflammatory bowel diseases, Crohn's disease, ulcerative colitis, cost-effectiveness, healthcare costs, budget impact, access to health services.

[1]
Huoponen, S.; Blom, M. A systematic review of the cost-effectiveness of biologics for the treatment of inflammatory bowel diseases. PLoS One, 2015, 10(12), e0145087.
[2]
Joensuu, J.T.; Huoponen, S.; Aaltonen, K.J.; Konttinen, Y.T.; Nordström, D.; Blom, M. The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review. PLoS One, 2015, 10(3), e0119683.
[3]
Zhang, W.; Islam, N.; Ma, C.; Anis, A.H. Systematic review of cost-effectiveness analyses of treatments for psoriasis. Pharmacoeconomics, 2015, 33(4), 327-340.
[4]
Laires, P.A.; Exposto, F.; Mesquita, R.; Martins, A.P.; Cunha-Miranda, L.; Fonseca, J.E. Patients’ access to biologics in rheumatoid arthritis: a comparison between Portugal and other European countries. Eur. J. Health Econ., 2013, 14(6), 875-885.
[5]
Putrik, P.; Ramiro, S.; Hifinger, M.; Keszei, A.P.; Hmamouchi, I.; Dougados, M.; Gossec, L.; Boonen, A. In wealthier countries, patients perceive worse impact of the disease although they have lower objectively assessed disease activity: results from the cross-sectional COMORA study. Ann. Rheum. Dis., 2016, 75(4), 715-720.
[6]
Putrik, P.; Ramiro, S.; Kvien, T.K.; Sokka, T.; Pavlova, M.; Uhlig, T.; Boonen, A. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann. Rheum. Dis., 2014, 73(1), 198-206.
[7]
Putrik, P.; Ramiro, S.; Kvien, T.K.; Sokka, T.; Uhlig, T.; Boonen, A. Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country’s wealth? Ann. Rheum. Dis., 2014, 73(11), 2010-2021.
[8]
Rencz, F.; Péntek, M.; Bortlik, M.; Zagorowicz, E.; Hlavaty, T.; Śliwczyński, A.; Diculescu, M.M.; Kupcinskas, L.; Gecse, K.B.; Gulácsi, L.; Lakatos, P.L. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World J. Gastroenterol., 2015, 21(6), 1728-1737.
[9]
Rencz, F.; Kemény, L.; Gajdácsi, J.Z.; Owczarek, W.; Arenberger, P.; Tiplica, G.S.; Stanimirović, A.; Niewada, M.; Petrova, G.; Marinov, L.T.; Kazandhieva, J.; Péntek, M.; Brodszky, V.; Gulácsi, L. Use of biologics for psoriasis in Central and Eastern European countries. J. Eur. Acad. Dermatol. Venereol., 2015, 29(11), 2222-2230.
[10]
Péntek, M.; Poór, G.; Wiland, P.; Olejárová, M.; Brzosko, M.; Codreanu, C.; Brodszky, N.; Gulácsi, L. Biological therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur. J. Health Econ., 2014, 15(Suppl. 1), S35-S43.
[11]
Dretzke, J.; Edlin, R.; Round, J.; Connock, M.; Hulme, C.; Czeczot, J.; Fry-Smith, A.; McCabe, C.; Meads, C. A systematic review and economic evaluation of the use of tumour necrosis factor-alpha (TNF-α) inhibitors, adalimumab and infliximab, for Crohn’s disease. Health Technol. Assess., 2011, 15(6), 1-244.
[12]
Boncz, I.; Sebestyén, A. Financial deficits in the health services of the UK and Hungary. Lancet, 2006, 368(9539), 917-918.
[13]
Dörner, T.; Strand, V.; Castañeda-Hernández, G.; Ferraccioli, G.; Isaacs, J.D.; Kvien, T.K.; Martin-Mola, E.; Mittendorf, T.; Smolen, J.S.; Burmester, G.R. The role of biosimilars in the treatment of rheumatic diseases. Ann. Rheum. Dis., 2013, 72(3), 322-328.
[14]
Dörner, T.; Strand, V.; Cornes, P.; Gonçalves, J.; Gulácsi, L.; Kay, J.; Kvien, T.K.; Smolen, J.; Tanaka, Y.; Burmester, G.R. The changing landscape of biosimilars in rheumatology. Ann. Rheum. Dis., 2016, 75(6), 974-982.
[15]
Vezér, B.; Buzás, Z.; Sebeszta, M.; Zrubka, Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr. Med. Res. Opin., 2016, 32(5), 829-834.
[16]
Fiorino, G.; Fazio, M.; Danese, S. Biosimilar therapies in inflammatory bowel disease: should we care about patient profile? Expert Rev. Clin. Immunol., 2016, 12(4), 361-363.
[17]
Reinisch, W.; Louis, E.; Danese, S. The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13. Expert Rev. Gastroenterol. Hepatol., 2015, 9(Suppl. 1), 17-26.
[18]
Nikiphorou, E.; Kautiainen, H.; Hannonen, P.; Asikainen, J.; Kokko, A.; Rannio, T.; Sokka, T. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin. Biol. Ther., 2015, 15(12), 1677-1683.
[19]
Strand, V.; Cronstein, B. Biosimilars: how similar? Intern. Med. J., 2014, 44(3), 218-223.
[20]
Mendes de Abreu, M.; Strand, V.; Levy, R.A.; Araujo, D.V. Putting the value into biosimilar decision making: the judgment value criteria. Autoimmun. Rev., 2014, 13(6), 678-684.
[21]
Yoo, D.H.; Hrycaj, P.; Miranda, P.; Ramiterre, E.; Piotrowski, M.; Shevchuk, S.; Kovalenko, V.; Prodanovic, N.; Abello-Banfi, M.; Gutierrez-Ureña, S.; Morales-Olazabal, L.; Tee, M.; Jimenez, R.; Zamani, O.; Lee, S.J.; Kim, H.; Park, W.; Müller-Ladner, U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann. Rheum. Dis., 2013, 72(10), 1613-1620.
[22]
Park, W.; Hrycaj, P.; Jeka, S.; Kovalenko, V.; Lysenko, G.; Miranda, P.; Mikazane, H.; Gutierrez-Ureña, S.; Lim, M.; Lee, Y.A.; Lee, S.J.; Kim, H.; Yoo, D.H.; Braun, J. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann. Rheum. Dis., 2013, 72(10), 1605-1612.
[23]
Baji, P.; Péntek, M.; Czirják, L.; Szekanecz, Z.; Nagy, G.; Gulácsi, L.; Brodszky, V. Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison. Eur. J. Health Econ., 2014, 15(Suppl. 1), S53-S64.
[24]
Baji, P.; Péntek, M.; Szántó, S.; Géher, P.; Gulácsi, L.; Balogh, O.; Brodszky, V. Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis. Eur. J. Health Econ., 2014, 15(Suppl. 1), S45-S52.
[25]
Takeuchi, T.; Yamanaka, H.; Tanaka, Y.; Sakurai, T.; Saito, K.; Ohtsubo, H.; Lee, S.J.; Nambu, Y. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod. Rheumatol., 2015, 25(6), 817-824.
[26]
Farkas, K.; Rutka, M.; Bálint, A.; Nagy, F.; Bor, R.; Milassin, Á.; Szepes, Z.; Molnár, T. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis - experiences from a single center. Expert Opin. Biol. Ther., 2015, 15(9), 1257-1262.
[27]
Gecse, K.B.; Lovász, B.D.; Farkas, K.; Banai, J.; Bene, L.; Gasztonyi, B.; Golovics, P.A.; Kristóf, T.; Lakatos, L.; Csontos, A.A.; Juhász, M.; Nagy, F.; Palatka, K.; Papp, M.; Patai, Á.; Lakner, L.; Salamon, Á.; Szamosi, T.; Szepes, Z.; Tóth, G.T.; Vincze, Á.; Szalay, B.; Molnár, T.; Lakatos, P.L. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: A prospective, multicentre, nationwide cohort. J. Crohn’s Colitis, 2016, 10(2), 133-140.
[28]
Jung, Y.S.; Park, D.I.; Kim, Y.H.; Lee, J.H.; Seo, P.J.; Cheon, J.H.; Kang, H.W.; Kim, J.W. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J. Gastroenterol. Hepatol., 2015, 30(12), 1705-1712.
[29]
NHS New Drugs Online database. Uk Medicines Information www.ukmi.nhs.uk (Accessed April 4, 2016).
[30]
European Medicines Agency. European Public Assessment Report for Inflectra, Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf
[31]
European Medicienes Agency. European Public Assessment Report for Remsima, Available from: http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
[32]
Ebbers, H.C. Biosimilars: in support of extrapolation of indications. J. Crohn’s Colitis, 2014, 8(5), 431-435.
[33]
Gulácsi, L.; Rencz, F.; Poór, G.; Szekanecz, Z.; Brodszky, V.; Baji, P.; Péntek, M. Patients’ access to biological therapy in chronic inflammatory conditions; per capita GDP does not explain the intercountry differences. Ann. Rheum. Dis., 2016, 75(5), 942-943.
[34]
Sokka, T.; Kautiainen, H.; Pincus, T.; Toloza, S.; da Rocha Castelar Pinheiro, G.; Lazovskis, J.; Hetland, M.L.; Peets, T.; Immonen, K.; Maillefert, J.F.; Drosos, A.A.; Alten, R.; Pohl, C.; Rojkovich, B.; Bresnihan, B.; Minnock, P.; Cazzato, M.; Bombardieri, S.; Rexhepi, S.; Rexhepi, M.; Andersone, D.; Stropuviene, S.; Huisman, M.; Sierakowski, S.; Karateev, D.; Skakic, V.; Naranjo, A.; Baecklund, E.; Henrohn, D.; Gogus, F.; Badsha, H.; Mofti, A.; Taylor, P.; McClinton, C.; Yazici, Y. Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database. Ann. Rheum. Dis., 2009, 68(11), 1666-1672.
[35]
Gulácsi, L.; Brodszky, V.; Baji, P.; Kim, H.; Kim, S.Y.; Cho, Y.Y.; Péntek, M. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev. Clin. Immunol., 2015, 11(Suppl. 1), S43-S52.
[36]
Farfan-Portet, M.I.; Gerkens, S.; Lepage-Nefkens, I.; Vinck, I.; Hulstaert, F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur. J. Health Econ., 2014, 15(3), 223-228.
[37]
Institute for Healthcare Informatics. Assessing biosimilar uptake and competition in European markets., 2014. Available from: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf
[38]
Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines The Role of Functioning Competitive Markets., 2016. Available from: http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
[39]
Neumann, D.; Jabłecka, A. Reimbursement of biosimilars in Poland: is there a link to health technology assessment? Expert Rev. Pharmacoecon. Outcomes Res., 2016, 16(6), 781-792.
[40]
Grabowski, H.; Guha, R.; Salgado, M. Biosimilar competition: lessons from Europe. Nat. Rev. Drug Discov., 2014, 13(2), 99-100.
[41]
Daubenfeld, T.; Dassow, J.; Keßler, M.; Schulze, J. Understanding the market dynamics of biosimilars. J. Bus. Chem., 2016, 13(1), 33-46.
[42]
Bocquet, F.; Fusier, I.; Cordonnier, A.; Lechat, P.; Paubel, P. Budget impact analysis of implementing tenders between the branded infliximab and its biosimilars in the public hospitals of paris. Value Health, 2015, 18(7), A639.
[43]
Rencz, F.; Gulácsi, L.; Péntek, M.; Gecse, K.B.; Dignass, A.; Halfvarson, J.; Gomollón, F.; Baji, P.; Peyrin-Biroulet, L.; Lakatos, P.L.; Brodszky, V. Cost-utility of biological treatment sequences for luminal Crohn’s disease in Europe. Expert Rev. Pharmacoecon. Outcomes Res., 2017, 17(6), 597-606.
[44]
Brodszky, V.; Baji, P.; Balogh, O.; Péntek, M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur. J. Health Econ., 2014, 15(Suppl. 1), S65-S71.
[45]
Brodszky, V.; Rencz, F.; Péntek, M.; Baji, P.; Lakatos, P.L.; Gulácsi, L. A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia. Expert Rev. Pharmacoecon. Outcomes Res., 2016, 16(1), 119-125.
[46]
Kim, S.; Hong, J.A.; Kudrin, A. 10th Congress of European Crohn’s and Colitis Organisation (ECCO), February 18-21, 20152015, Vol. 66, pp. S512-S512.
[47]
Kim, S.C.; Choi, N.K.; Lee, J.; Kwon, K.E.; Eddings, W.; Sung, Y.K.; Song, H.J.; Kesselheim, A.S.; Solomon, D.H. Uptake of the first biosimilar infliximab since its approval in south korea. Arthritis Rheumatol., 2015, 67, 1615-1616.
[48]
Jha, A.; Upton, A.; Dunlop, W.C.; Akehurst, R. Remsima(R) for the treatment of autoimmune diseases in five european countries. Adv. Ther., 2015, 32(8), 742-756.
[49]
Lucioni, C.; Mazzi, S.; Caporali, R. Budget impact analysis of infliximab biosimilar: The Italian scenery. Global & Regional Health Technology Assessment, 2015, 2(2), 78-88.
[50]
McCarthy, G.; Ebel Bitoun, C.; Guy, H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health, 2013, 16(7), A558.
[51]
US doctors poised to prescribe biosimilars. GaBI Online - Generics and Biosimilars Initiative. 03/25/2016. Available from: http://www.gabionline.net/Biosimilars/General/US-doctors-poised-to-prescribe-biosimilars (Accessed April 4, 2016).
[52]
Ruff, L.; Rezk, M.F.; Uhlig, T.; Gommers, J.W. Budget impact analysis of an etanercept biosimilar for the treatment of all licensed etanercept indications for adults in europe. Value Health, 2015, 18(7), A639.
[53]
Ruff, L.; Rezk, M.F.; Uhlig, T.; Gommers, J.W. Budget impact analysis of an etanercept biosimilar for the treatment of rheumatoid arthritis in europe. Value Health, 2015, 18(7), A639.
[54]
Canadian Agency for Drugs and Technologies in Health. Guidelines for the Economic Evaluation of Health Technologies., Available from: https://www.cadth.ca/media/pdf/186_EconomicGuidelines_e.pdf
[55]
National Institute for Health and Care Excellence (NICE). Guide to the Methods of Technology Appraisal, Available from: http://www.nice.org.uk/article/pmg9/resources/non-guidance-guide-to-the-methods-of-technology-appraisal-2013-pdf
[56]
Claxton, K.; Martin, S.; Soares, M.; Rice, N.; Spackman, E.; Hinde, S.; Devlin, N.; Smith, P.C.; Sculpher, M. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol. Assess., 2015, 19(14), 1-503. v-vi.
[57]
Gulácsi, L.; Rotar, A.M.; Niewada, M.; Löblová, O.; Rencz, F.; Petrova, G.; Boncz, I.; Klazinga, N.S. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. Eur. J. Health Econ., 2014, 15(Suppl. 1), S13-S25.
[58]
Siegel, J.E.; Torrance, G.W.; Russell, L.B.; Luce, B.R.; Weinstein, M.C.; Gold, M.R. Guidelines for pharmacoeconomic studies. Recommendations from the panel on cost effectiveness in health and medicine. Panel on cost effectiveness in health and medicine. Pharmacoeconomics, 1997, 11(2), 159-168.
[59]
Cleemput, I.; Neyt, M.; Thiry, N.; De Laet, C.; Leys, M. Threshold values for cost-effectiveness in healthcare Health Technology Assessment (HTA). Brussels: Belgian Health Care Knowledge Centre (KCE); 2008. CE reports 100C (D/2008/10.273/96).
[60]
Cleemput, I.; Neyt, M.; Thiry, N.; De Laet, C.; Leys, M. Using threshold values for cost per quality-adjusted life-year gained in healthcare decisions. Int. J. Technol. Assess. Health Care, 2011, 27(1), 71-76.
[61]
Neumann, P.J.; Cohen, J.T.; Weinstein, M.C. Updating cost-effectiveness--the curious resilience of the $50,000-per-QALY threshold. N. Engl. J. Med., 2014, 371(9), 796-797.
[62]
Nanavaty, M.; Kaura, S.; Mwamburi, M.; Gogate, A.; Proach, J.; Nyandege, A.; Khan, Z.M. The use of incremental cost-effectiveness ratio thresholds in health technology assessment decisions. J. Clin. Pathways, 2015, 1(1), 29-36.
[63]
[64]
Ananthakrishnan, A.N.; Hur, C.; Juillerat, P.; Korzenik, J.R. Strategies for the prevention of postoperative recurrence in Crohn’s disease: results of a decision analysis. Am. J. Gastroenterol., 2011, 106(11), 2009-2017.
[65]
Ananthakrishnan, A.N.; Hur, C.; Korzenik, J.R. Certolizumab pegol compared to natalizumab in patients with moderate to severe Crohn’s disease: results of a decision analysis. Dig. Dis. Sci., 2012, 57(2), 472-480.
[66]
Arseneau, K.O.; Cohn, S.M.; Cominelli, F.; Connors, A.F., Jr Cost-utility of initial medical management for Crohn’s disease perianal fistulae. Gastroenterology, 2001, 120(7), 1640-1656.
[67]
Assasi, N.; Blackhouse, G.; Xie, F.; Gaebel, K.; Marshall, J.; Irvine, E.J.; Giacomini, M.; Robertson, D.; Campbell, K.; Hopkins, R.; Goeree, R. Anti-TNF-α drugs for refractory inflammatory bowel disease: Clinical- and costeffectiveness analyses [Technology report number 120]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.
[68]
Blackhouse, G.; Assasi, N.; Xie, F.; Marshall, J.; Irvine, E.J.; Gaebel, K.; Campbell, K.; Hopkins, R.; O’Reilly, D.; Tarride, J.E.; Goeree, R. Canadian cost-utility analysis of initiation and maintenance treatment with anti-TNF-α drugs for refractory Crohn’s disease. J. Crohn’s Colitis, 2012, 6(1), 77-85.
[69]
Bodger, K.; Kikuchi, T.; Hughes, D. Cost-effectiveness of biological therapy for Crohn’s disease: Markov cohort analyses incorporating United Kingdom patient-level cost data. Aliment. Pharmacol. Ther., 2009, 30(3), 265-274.
[70]
Clark, W.; Raftery, J.; Song, F.; Barton, P.; Cummins, C.; Fry-Smith, A.; Burls, A. Systematic review and economic evaluation of the effectiveness of infliximab for the treatment of Crohn’s disease. Health Technol. Assess., 2003, 7(3), 1-67.
[71]
Doherty, G.A.; Miksad, R.A.; Cheifetz, A.S.; Moss, A.C. Comparative cost-effectiveness of strategies to prevent postoperative clinical recurrence of Crohn’s disease. Inflamm. Bowel Dis., 2012, 18(9), 1608-1616.
[72]
Jaisson-Hot, I.; Flourié, B.; Descos, L.; Colin, C. Management for severe Crohn’s disease: a lifetime cost-utility analysis. Int. J. Technol. Assess. Health Care, 2004, 20(3), 274-279.
[73]
Kaplan, G.G.; Hur, C.; Korzenik, J.; Sands, B.E. Infliximab dose escalation vs. initiation of adalimumab for loss of response in Crohn’s disease: a cost-effectiveness analysis. Aliment. Pharmacol. Ther., 2007, 26(11-12), 1509-1520.
[74]
Lindsay, J.; Punekar, Y.S.; Morris, J.; Chung-Faye, G. Health-economic analysis: cost-effectiveness of scheduled maintenance treatment with infliximab for Crohn’s disease--modelling outcomes in active luminal and fistulizing disease in adults. Aliment. Pharmacol. Ther., 2008, 28(1), 76-87.
[75]
Loftus, E.V., Jr; Johnson, S.J.; Yu, A.P.; Wu, E.Q.; Chao, J.; Mulani, P.M. Cost-effectiveness of adalimumab for the maintenance of remission in patients with Crohn’s disease. Eur. J. Gastroenterol. Hepatol., 2009, 21(11), 1302-1309.
[76]
Marchetti, M.; Liberato, N.L.; Di Sabatino, A.; Corazza, G.R. Cost-effectiveness analysis of top-down versus step-up strategies in patients with newly diagnosed active luminal Crohn’s disease. Eur. J. Health Econ., 2013, 14(6), 853-861.
[77]
Marshall, J.; Blackhouse, G.; Goeree, R.; Brazier, N.; Irvine, E.; Faulkner, L.; Dipchand, C.; O’Brien, B. Infliximab for the treatment of Crohn's disease: A systematic review and cost-utility analysis. Ottawa: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); 2002. Technology report no 24,, 2002.
[78]
Saito, S.; Shimizu, U.; Nan, Z.; Mandai, N.; Yokoyama, J.; Terajima, K.; Akazawa, K. Economic impact of combination therapy with infliximab plus azathioprine for drug-refractory Crohn’s disease: A cost-effectiveness analysis. J. Crohn’s Colitis, 2013, 7(2), 167-174.
[79]
Tang, D.H.; Armstrong, E.P.; Lee, J.K. Cost-utility analysis of biologic treatments for moderate-to-severe Crohn’s disease. Pharmacotherapy, 2012, 32(6), 515-526.
[80]
Yu, A.P.; Johnson, S.; Wang, S.T.; Atanasov, P.; Tang, J.; Wu, E.; Chao, J.; Mulani, P.M. Cost utility of adalimumab versus infliximab maintenance therapies in the United States for moderately to severely active Crohn’s disease. Pharmacoeconomics, 2009, 27(7), 609-621.
[81]
Saito, S.; Shimizu, U.; Nan, Z.; Yokoyama, J.; Watanabe, M.; Terajima, K.; Akazawa, K. A health economic analysis of combination therapy with infliximab plus elemental diet for moderately to severely active Crohn’s disease. Health, 2014, 6(1), 107-114.
[82]
Rafia, R.; Scope, A.; Harnan, S.; Stevens, J.; Stevenson, M.; Sutton, A.; Dickinson, K.; Parkes, M.; Mayberry, J.; Lobo, A. Vedolizumab for the treatment of adults with moderately to severely active Crohn’s disease: A Single Technology Appraisal. School of Health and Related Research (ScHARR); Shef-field, 2014.
[83]
Cadth canadian drug expert committee final recommendation on Vedolizumab (2015). Available from: https://www.cadth.ca/sites/default/files/cdr/complete/SR0421_cdr_complete_Entyvio_Nov-2-15_e.pdf Last accessed: 11/02/2019.
[84]
Essat, M.; Tappenden, P.; Ren, S.; Bessey, A.; Archer, R.; Wong, R.; Lobo, A.; Hoque, S. Vedolizumab for the treatment of adults with moderate-to-severe active ulcerative colitis: An evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics, 2016, 34(3), 245-257.
[85]
Essat, M.; Tappenden, P.; Ren, S.; Bessey, A.; Archer, R.; Wong, R.; Lobo, A.; Hoque, S. Vedolizumab for the treatment of adults with moderate-to-severe active ulcerative colitis: An evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics, 2016, 34(3), 245-257.
[86]
Deiana, S.; Gabbani, T.; Annese, V. Biosimilars in inflammatory bowel disease: A review of post-marketing experience. World J. Gastroenterol., 2017, 23(2), 197-203.
[87]
Danese, S.; Fiorino, G.; Michetti, P. Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: An updated survey. J. Crohn’s Colitis, 2016, 10(11), 1362-1365.
[88]
Peyrin-Biroulet, L.; Lönnfors, S.; Roblin, X.; Danese, S.; Avedano, L. Patient perspectives on biosimilars: A Survey by the european federation of crohn’s and ulcerative colitis associations. J. Crohn’s Colitis, 2017, 11(1), 128-133.
[89]
Danese, S.; Fiorino, G.; Raine, T.; Ferrante, M.; Kemp, K.; Kierkus, J.; Lakatos, P.L.; Mantzaris, G.; van der Woude, J.; Panes, J.; Peyrin-Biroulet, L. ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update. J. Crohn’s Colitis, 2017, 11(1), 26-34.
[90]
Grabowski, D.; Henderson, B.; Lam, D.; Keystone, E.C.; Thorne, C.; Jamal, S.; Pope, J.; Haraoui, B.; Lin, D.; Revers, L. Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists. Clin. Rheumatol., 2015, 34(8), 1427-1433.
[91]
Derbyshire, M. Update on US state legislation on biosimilars substitution. GaBi J., 2015, 4(2), 95-97.
[92]
Idaho governor signs biosimilars substitution bill. GaBI Online - Generics and Biosimilars Initiative. 01/04/2016. Available from: http://www.gabionline.net/Policies-Legislation/Idaho-governor-signs-biosimilars-substitution-bill?utm_source=GONL&utm_campaign=ef11f2f6b4-V16D01&utm_medium=email&utm_term=0_8eba798fe9-ef11f2f6b4-25372405 (Accessed April 4, 2016).
[93]
Declerck, P.; Simoens, S. A European perspective on the market accessibility of biosimilars. Biosimilars, 2012, 2, 33-40.
[94]
BSG guidance recommends switching to biosimilar infliximab. GaBI Online - Generics and Biosimilars Initiative. 25/03/2016. Available from: http://www.gabionline.net/Guidelines/BSG-guidance-recommends-switching-to-biosimilar-infliximab (Accessed April 4, 2016) (25/03/2016).
[95]
Gulácsi, L.; Péntek, M. HTA in central and eastern European countries; the 2001: A Space Odyssey and efficiency gain. Eur. J. Health Econ., 2014, 15(7), 675-680.
[96]
Ben-Horin, S.; Vande Casteele, N.; Schreiber, S.; Lakatos, P.L. Biosimilars in inflammatory bowel disease: facts and fears of extrapolation. Clin. Gastroenterol. Hepatol., 2016, 14(12), 1685-1696.
[97]
Baji, P.; Gulácsi, L.; Lovász, B.D.; Golovics, P.A.; Brodszky, V.; Péntek, M.; Rencz, F.; Lakatos, P.L. Treatment preferences of originator versus biosimilar drugs in Crohn’s disease; discrete choice experiment among gastroenterologists. Scand. J. Gastroenterol., 2016, 51(1), 22-27.
[98]
Baji, P.; Gulácsi, L.; Golovics, P.A.; Lovász, B.D.; Péntek, M.; Brodszky, V.; Rencz, F.; Lakatos, P.L. Perceived risks contra benefits of using biosimilar drugs in ulcerative colitis: Discrete choice experiment among gastroenterologists. Value Health Reg. Issues, 2016, 10, 85-90.
[99]
Danese, S.; Fiorino, G.; Michetti, P. 11th Congress of European Crohn’s and Colitis Organisation (ECCO), March 16-19, 2016Amsterdam, The Netherlands2016.
[100]
Danese, S.; Gomollon, F. ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J. Crohn’s Colitis, 2013, 7(7), 586-589.
[101]
Wilkins, A.R.; Venkat, M.V.; Brown, A.S.; Dong, J.P.; Ran, N.A.; Hirsch, J.S.; Close, K.L. Patient perspectives on biosimilar insulin. J. Diabetes Sci. Technol., 2014, 8(1), 23-25.


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Article Details

VOLUME: 26
ISSUE: 2
Year: 2019
Page: [259 - 269]
Pages: 11
DOI: 10.2174/0929867324666170406112304
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