Budget impact of introducing subcutaneous vedolizumab as a maintenance therapy in biologic-naïve and biologic-experienced patients with ulcerative colitis in France

References

• Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851.
   PubMed Web of Science ®Google Scholar
• Ghosh S, Mitchell R. Impact of inflammatory bowel disease on quality of life: results of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) patient survey. J Crohns Colitis. 2007;1(1):10–20.
   PubMed Web of Science ®Google Scholar
• GBD 2017 group, Alatab S, Sepanlou SG, Ikuta K, et al. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17–30.
   PubMed Web of Science ®Google Scholar
• Nerich V, Monnet E, Etienne A, et al. Geographical variations of inflammatory bowel disease in France: a study based on national health insurance data. Inflamm Bowel Dis. 2006;12(3):218–226.
   PubMed Web of Science ®Google Scholar
• Chouraki V, Savoye G, Dauchet L, et al. The changing pattern of Crohn’s disease incidence in northern France: a continuing increase in the 10- to 19-year-old age bracket (1988-2007). Aliment Pharmacol Ther. 2011;33(10):1133–1142.
   PubMed Web of Science ®Google Scholar
• Epimad Group, Ghione S, Sarter H, Fumery M, et al. Dramatic increase in incidence of ulcerative colitis and Crohn’s disease (1988-2011): a population-based study of French adolescents. Am J Gastroenterol. 2018;113(2):265–272.
   PubMed Web of Science ®Google Scholar
• Danese S, Allez M, van Bodegraven AA, et al. Unmet medical needs in ulcerative colitis: an expert group consensus. Dig Dis. 2019;37(4):266–283.
   PubMed Web of Science ®Google Scholar
• Lawton J, Achit H, Pouillon L, et al. Cost-of-illness of inflammatory bowel disease patients treated with anti-tumour necrosis factor: a French large single-center experience. United European Gastroenterol J. 2019;7(7):908–913.
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Misery L, Naeyaert S, et al. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Front Pharmacol. 2019;10:279.
   PubMed Web of Science ®Google Scholar
• Kostic M, Djakovic L, Sujic R, et al. Inflammatory bowel diseases (crohn s disease and ulcerative colitis): cost of treatment in Serbia and the implications. Appl Health Econ Health Policy. 2017;15(1):85–93.
   PubMed Web of Science ®Google Scholar
• Harbord M, Eliakim R, Bettenworth D, et al. European Crohn’s and Colitis Organisation [ECCO]. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017;11(7):769–784.
   PubMed Web of Science ®Google Scholar
• Armuzzi A, DiBonaventura MD, Tarallo M, et al. Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe. PLoS One. 2020;15(1):e0227914.
   PubMed Web of Science ®Google Scholar
• Janssen Biologics BV. Ustekinumab (summary of product characteristics). Leiden The Netherlands: European Medicines Agency; 2021.
   Google Scholar
• Wilson MR, Bergman A, Chevrou-Severac H, et al. Cost-effectiveness of vedolizumab compared with infliximab, Adalimumab, and golimumab in patients with ulcerative colitis in the United Kingdom. Eur J Health Econ. 2018;19(2):229–240.
   PubMed Web of Science ®Google Scholar
• Gordon JP, McEwan PC, Maguire A, et al. Characterizing unmet medical need and the potential role of new biologic treatment options in patients with ulcerative colitis and Crohn’s disease: a systematic review and clinician surveys. Eur J Gastroenterol Hepatol. 2015;27(7):804–812.
   PubMed Web of Science ®Google Scholar
• Takeda Pharma A/S. Vedolizumab (summary of product characteristics). Taastrup Denmark: European Medicines Agency; 2020.
   Google Scholar
• Takeda Pharmaceuticals Australia Pty Ltd. Entyvio® (vedolizumab). Australian product information. Sydney Australia: GuildLink; 2020.
   Google Scholar
• Takeda Canada Inc. Entyvio® vedolizumab (product monograph). Toronto Ontario Canada; 2020. Available from: https://www.takeda.com/4a11e2/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/entyvio/entyvio-pm-en.pdf
   Google Scholar
• Takeda Pharmaceutical Company Limited. Update on the U.S. development program for the investigational subcutaneous formulation of ENTYVIO® (vedolizumab) as a maintenance therapy in adults with moderate to severe ulcerative colitis 2020 [ updated 2020 Sep 1; cited 2021 Feb 24]. Available from: https://www.takeda.com/newsroom/statements/2020/update-on-the-u.s.-development-program-for-the-investigational-subcutaneous-formulation-of-entyvio-vedolizumab-as-a-maintenance-therapy-in-adults-with-moderate-to-severe-ulcerative-colitis/
   Google Scholar
• Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force. Value Health. 2014;17(1):5–14.
   PubMed Web of Science ®Google Scholar
• Haute Autorité de Sante. Transparency Committee Opinion, 3 October 2012. Adalimumab, ATC code L04AB04 (TNF inhibitor) cited 2021 Jun 8]. Available from 2021 Jun 8: https://www.has-sante.fr/upload/docs/application/pdf/2013-07/humira_ct_12238.pdf
   Google Scholar
• Ducimetière P. Apport du registre EPIMAD. De l’épidémiologie descriptive à l’analytique 2015 cited 2021 Apr 19]. Available from 2021 Apr 19: http://www.observatoire-crohn-rch.fr/wp-content/uploads/2015/09/EPIMAD-donne%CC%81es-re%CC%81centes.pdf
   Google Scholar
• GEMINI 1 Study Group, Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710.
   PubMed Web of Science ®Google Scholar
• de Saint Pol T. Institut national de la statistique et des études économiques. Corps et appartenance sociale: la corpulence en Europe. Données sociales - La société française. 2006: 649–656
   Google Scholar
• Jairath V, Chan K, Lasch K, et al. Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis. Expert Rev Gastroenterol Hepatol. 2021;15(6):711–722.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Tsai HH, Punekar YS, Morris J, et al. A model of the long-term cost effectiveness of scheduled maintenance treatment with infliximab for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2008;28(10):1230–1239.
   PubMed Web of Science ®Google Scholar
• Frolkis AD, Dykeman J, Negrón ME, et al. Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta-analysis of population-based studies. Gastroenterology. 2013;145(5):996–1006.
   PubMed Web of Science ®Google Scholar
• Cohen R, Skup M, Ozbay AB, et al. Direct and indirect healthcare resource utilization and costs associated with ulcerative colitis in a privately-insured employed population in the US. J Med Econ. 2015;18(6):447–456.
   PubMed Web of Science ®Google Scholar
• Cohen RD, Yu AP, Wu EQ, et al. Systematic review: the costs of ulcerative colitis in Western countries. Aliment Pharmacol Ther. 2010;31(7):693–707.
   PubMed Web of Science ®Google Scholar
• Malone DC, Waters HC, Van Den Bos J, et al. A claims-based Markov model for Crohn’s disease. Aliment Pharmacol Ther. 2010;32(3):448–458.
   PubMed Web of Science ®Google Scholar
• Rubin DT, Mody R, Davis KL, et al. Real-world assessment of therapy changes, suboptimal treatment and associated costs in patients with ulcerative colitis or Crohn’s disease. Aliment Pharmacol Ther. 2014;39(10):1143–1155.
   PubMed Web of Science ®Google Scholar
• Sécurité Sociale l’Assurance Maladie. Codage website, France 2021 cited 2021 Feb 25]. Available from 2021 Feb 25: http://www.codage.ext.cnamts.fr/codif/bdm_it/index.php?p_site=AMELI
   Google Scholar
• Aide au Codage. Aide au codage website, France 2021 [ cited 2021 Feb 25]. Available from: https://www.aideaucodage.fr
   Google Scholar
• Essat M, Tappenden P, Ren S, et al. 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.
   PubMed Web of Science ®Google Scholar
• Yokomizo L, Limketkai B, Park KT. Cost-effectiveness of Adalimumab, infliximab or vedolizumab as first-line biological therapy in moderate-to-severe ulcerative colitis. BMJ Open Gastroenterol. 2016;3(1):e000093.
   PubMedGoogle Scholar
• Wilson M, Lucas A, Cameron A, et al. Budget impact of adding vedolizumab to a health plan formulary as another first-line biologic option for ulcerative colitis and Crohn’s disease. Am Health Drug Benefits. 2018;11(5):253–262.
   PubMed Web of Science ®Google Scholar