Budesonide with multi-matrix technology as second-line treatment for ulcerative colitis: evaluation of long-term cost-effectiveness in the Netherlands

References

• GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 2016;388:1545-602
   PubMed Web of Science ®Google Scholar
• Kappelman MD, Rifas-Shiman SL, Kleinman K, et al. The prevalence and geographic distribution of Crohn’s disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol 2007;5:1424-29
   PubMed Web of Science ®Google Scholar
• Bernstein CN, Wajda A, Svenson LW, et al. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol 2006;101:1559-68
   PubMed Web of Science ®Google Scholar
• Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012;142:46-54.e42
   PubMed Web of Science ®Google Scholar
• Shivananda S, Lennard-Jones J, Logan R, et al. Incidence of inflammatory bowel disease across Europe: is there a difference between north and south? Results of the European Collaborative Study on Inflammatory Bowel Disease (EC-IBD). Gut 1996;39:690-7
   PubMed Web of Science ®Google Scholar
• Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology 2011;140:1785-94
   PubMed Web of Science ®Google Scholar
• Burisch J, Jess T, Martinato M, Lakatos PL; on behalf of the European Crohn’s and Colitis Organisation, ECCO. The burden of inflammatory bowel disease in Europe. J Crohns Colitis 2013;7:322-37
   PubMed Web of Science ®Google Scholar
• de Groof EJ, Rossen NGM, van Rhijn BD, et al. Burden of disease and increasing prevalence of inflammatory bowel disease in a population-based cohort in the Netherlands. Eur J Gastroenterol Hepatol 2016;28:1065-72
   PubMed Web of Science ®Google Scholar
• Wilson B, Lonnfors S, Hommes DW, et al. P406 A European Crohn’s and ulcerative colitis patient life IMPACT survey. J Crohns Colitis 2012;6:S171
   Google Scholar
• NIDDK: Ulcerative colitis. US: National Institute of Diabetes and Digestive and Kidney Diseases, 2014. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis [Last accessed 8 January 2018]
   Google Scholar
• Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006;55:749-53
   PubMed Web of Science ®Google Scholar
• Nielsen OH, Munck LK. Drug insight: aminosalicylates for the treatment of IBD. Nat Clin Pract Gastroenterol Hepatol 2007;4:160-70
   PubMedGoogle Scholar
• Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis 2017;11:769-84
   PubMed Web of Science ®Google Scholar
• Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:501-23
   PubMed Web of Science ®Google Scholar
• Truelove SC, Watkinson G, Draper G. Comparison of corticosteroid and sulphasalazine therapy in ulcerative colitis. BMJ 1962;2:1708-11
   PubMed Web of Science ®Google Scholar
• Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med 2003;114:39-43
   PubMed Web of Science ®Google Scholar
• Kozuch PL, Hanauer SB. Treatment of inflammatory bowel disease: a review of medical therapy. World J Gastroenterol 2008;14:354-77
   PubMed Web of Science ®Google Scholar
• Danese S, Siegel CA, Peyrin-Biroulet L. Review article: integrating budesonide-MMX into treatment algorithms for mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther 2014;39:1095-103
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Bengtsson B, Hapten-White L, Rutgeerts P. Oral budesonide for maintenance of remission of Crohn’s disease: a pooled safety analysis. Aliment Pharmacol Ther 2009;29:643-53
   PubMed Web of Science ®Google Scholar
• Rutgeerts P, Lofberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn’s disease. N Engl J Med 1994;331:842-5
   PubMed Web of Science ®Google Scholar
• Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther 2006;23:577-85
   PubMed Web of Science ®Google Scholar
• Uceris (budesonide) extended release tablets, for oral use [package insert]. Raleigh, NC: Salix Pharmaceuticals Inc., 2014
   Google Scholar
• Brunner M, Ziegler S, Di Stefano AFD, et al. Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation. Br J Clin Pharmacol 2006;61:31-8
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Travis S, Moro L, et al. Once-daily budesonide MMX extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology 2012;143:1218-26
   PubMed Web of Science ®Google Scholar
• Travis SPL, Danese S, Kupcinskas L, et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut 2014;63:433-41
   PubMed Web of Science ®Google Scholar
• Dubinsky MC. Reviewing treatments and outcomes in the evolving landscape of ulcerative colitis. Postgrad Med 2017;129:538-53
   PubMed Web of Science ®Google Scholar
• Guideline for economic evaluations in healthcare. The Netherlands: Zorginstituut Nederland [Dutch Care Institute], 2017. Available at: https://www.zorginstituutnederland.nl/binaries/content/documents/zinl-www/documenten/publicaties/publications-in-english/2016/1606-guideline-for-economic-evaluations-in-healthcare/Guideline+for+economic+evaluations+in+healthcare.pdf [Last accessed 8 January 2018]
   Google Scholar
• Travis SPL, Stange EF, Lémann M, et al. European evidence-based consensus on the management of ulcerative colitis: current management. J Crohns Colitis 2008;2:24-62
   PubMed Web of Science ®Google Scholar
• Handleiding Behandeling IBD – 2014–2015 [Treatment Manual for IBD]. The Netherlands: Initiatief in Crohn en Colitis en Nederlandse Vereniging van Maag-. Darm- en Leverartsen [Initiative in Crohn’s and Colitis and Dutch Association of Stomach, Gut and Liver Doctors], 2015. Available at: https://www.crohn-colitis.nl/wp-content/uploads/2016/09/Modernisering-IBD-richtlijn-volwassenen-2009.pdf [Last accessed 17 May 2017]
   Google Scholar
• National Institute for Health and Care Excellence (NICE). NICE Decision Support Unit Technical Support Documents. London: National Institute for Health and Care Excellence (NICE), 2010 – 19 May 2017. Available at: https://www.ncbi.nlm.nih.gov/books/?term=collection-id_nicedsutsd%5BAttribute%5D [Last accessed 19 May 2017]
   Google Scholar
• Lennard-Jones JE, Longmore AJ, Newell AC, et al. An assessment of prednisone, salazopyrin, and topical hydrocortisone hemisuccinate used as out-patient treatment for ulcerative colitis. Gut 1960;1:217-22
   PubMed Web of Science ®Google Scholar
• Lakatos PL, Lakatos L. Once daily 5-aminosalicylic acid for the treatment of ulcerative colitis; are we there yet? Pharmacol Res 2008;58:190-5
   PubMed Web of Science ®Google Scholar
• Ardizzone S, Maconi G, Russo A, et al. Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. Gut 2006;55:47-53
   PubMed Web of Science ®Google Scholar
• Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462-76
   PubMed Web of Science ®Google Scholar
• Solberg IC, Lygren I, Jahnsen J, et al. Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study). Scand J Gastroenterol 2009;44:431-40
   PubMed Web of Science ®Google Scholar
• van der Valk ME, Mangen M-JJ, Leenders M, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFα therapy: results from the COIN study. Gut 2014;63:72-9
   PubMed Web of Science ®Google Scholar
• Jeuring SFG, Bours PHA, Zeegers MP, et al. Disease outcome of ulcerative colitis in an era of changing treatment strategies: results from the Dutch population-based IBDSL cohort. J Crohns Colitis 2015;9:837-45
   PubMed Web of Science ®Google Scholar
• Romberg-Camps M, Kuiper E, Schouten L, et al. Mortality in inflammatory bowel disease in the Netherlands 1991–2002: results of a population-based study: the IBD South-Limburg cohort. Inflamm Bowel Dis 2010;16:1397-410
   PubMed Web of Science ®Google Scholar
• Mortality; key figures. The Netherlands: Centraal Bureau voor de Statistiek [Central Bureau of Statistics], 2018. Available at: http://statline.cbs.nl/Statweb/publication/?DM=SLEN&PA=37979ENG&D1=1&D2=0&D3=l&LA=EN&VW=T [Last accessed 8 January 2018]
   Google Scholar
• Fleurence RL, Hollenbeak CS. Rates and probabilities in economic modelling: transformation, translation and appropriate application. PharmacoEconomics 2007;25:3-6
   PubMed Web of Science ®Google Scholar
• Rubin DT, Sandborn WJ, Bosworth B, et al. Budesonide foam has a favorable safety profile for inducing remission in mild-to-moderate ulcerative proctitis or proctosigmoiditis. Dig Dis Sci 2015;60:3408-17
   PubMed Web of Science ®Google Scholar
• Rhodes JM, Robinson R, Beales I, et al. Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis. Aliment Pharmacol Ther 2008;27:228-40
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Robinson M, Pruitt R, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. U.S. Budesonide enema study group. Gastroenterology 1998;115:525-32
   PubMed Web of Science ®Google Scholar
• Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther 2006;23:303-12
   PubMed Web of Science ®Google Scholar
• Hartmann F, Stein J, BudMesa-Study Group. Clinical trial: controlled, open, randomized multicenter study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left-sided ulcerative colitis. Aliment Pharmacol Ther 2010;32:368-76
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology 2015;148:740-50
   PubMed Web of Science ®Google Scholar
• Medicijn kosten [Medication costs]. The Netherlands: Zorginstituut Nederland [Dutch Care Institute], 2017. Available at: https://www.medicijnkosten.nl/ [Last accessed 8 January 2018]
   Google Scholar
• Bijlage 1 – Kostenhandleiding – Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg [Appendix 1 – Cost Manual – Methodology of cost research and reference prices for economic evaluations in health care]. Erasmus Universiteit Rotterdam: Zorginstituut Nederland [Dutch Care Institute], 2016. Available at: https://www.zorginstituutnederland.nl/over-ons/publicaties/publicatie/2016/02/29/richtlijn-voor-het-uitvoeren-van-economische-evaluaties-in-de-gezondheidszorg [Last accessed 8 January 2018]
   Google Scholar
• Sandborn WJ, Kamm MA, Lichtenstein GR, et al. MMX Multi matrix system mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Aliment Pharmacol Ther 2007;26:205-15
   PubMed Web of Science ®Google Scholar
• van der Valk ME, Mangen M-JJ, Severs M, et al. Evolution of costs of inflammatory bowel disease over two years of follow-up. PLoS One 2016;11:e0142481
   PubMed Web of Science ®Google Scholar
• Blommestein HM, de Groot S, Aarts MJ, et al. Cost-effectiveness of obinutuzumab for chronic lymphocytic leukaemia in The Netherlands. Leuk Res 2016;50:37-45
   PubMed Web of Science ®Google Scholar
• Consumer prices; price index 2015. The Netherlands: Centraal Bureau voor de Statistiek [Central Bureau of Statistics], 2015. Available at: http://statline.cbs.nl/Statweb/publication/?DM=SLEN&PA=83131ENG&D1=0&D2=0&D3=195-206,208-219,221-232,234-245,247-258,260-271,273-276&LA=EN&VW=T [Last accessed 8 January 2018]
   Google Scholar
• Prenzler A, Yen L, Mittendorf T, von der Schulenburg J-M. Cost effectiveness of ulcerative colitis treatment in Germany: a comparison of two oral formulations of mesalazine. BMC Health Serv Res 2011;5:157
   Web of Science ®Google Scholar
• Arseneau KO, Sultan S, Provenzale DT, et al. Do patient preferences influence decisions on treatment for patients with steroid-refractory ulcerative colitis? Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc 2006;4:1135-42
   PubMed Web of Science ®Google Scholar
• Klassen AF, Newton JN, Mallon E. Measuring quality of life in people referred for specialist care of acne: comparing generic and disease-specific measures. J Am Acad Dermatol 2000;43(2):229-33
   PubMed Web of Science ®Google Scholar
• Léger D, Morin CM, Uchiyama M, et al. Chronic insomnia, quality-of-life, and utility scores: comparison with good sleepers in a cross-sectional international survey. Sleep Med 2012;13:43-51
   PubMed Web of Science ®Google Scholar
• Ekbäck MP, Lindberg M, Benzein E, Årestedt K. Health-related quality of life, depression and anxiety correlate with the degree of hirsutism. Dermatol Basel Switz 2013;227(3):278-84
   PubMed Web of Science ®Google Scholar
• Shabaruddin FH, Chen L-C, Elliott RA, Payne K. A systematic review of utility values for chemotherapy-related adverse events. PharmacoEconomics 2013;31:277-88
   PubMed Web of Science ®Google Scholar
• Briggs A, Claxton K, Sculpher M. Decision Modelling for Health Economic Evaluation. Oxford: Handbooks in Health Economic Evaluation, 2006
   Google Scholar
• Kamm MA, Lichtenstein GR, Sandborn WJ, et al. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut 2008;57:893-902
   PubMed Web of Science ®Google Scholar
• Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology 2007;132:66-75
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Kamm MA, Boddu P, et al. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol 2007;5:95-102
   PubMed Web of Science ®Google Scholar
• Brereton N, Bodger K, Kamm MA, et al. A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the treatment of mild-to-moderate ulcerative colitis from a UK perspective. J Med Econ 2010;13:148-61
   PubMedGoogle Scholar
• Pruszko C, Jachimowicz M, Kowalczyk M, et al. Economic implications of budesonide MMX advantage in ulcerative colitis treatment over systemic steroids: budesonide MMX decreases ulcerative colitis treatment costs. Poster PGI15. ISPOR 21st Annual International Meeting, Washington, USA, 21–25 May 2016
   Google Scholar
• Scottish Medicines Consortium. Resubmission. Budesonide 9m prolonged release tablet (Cortiment). SMC No. (1093/15). 9 September 2016. Available at: https://www.scottishmedicines.org.uk/media/1371/budesonide_cortiment_resub_final_sept_2016_for_website.pdf [Last accessed 16 May 2018]
   Google Scholar
• D’Haens G, Sandborn WJ, Feagam BG, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology 2007;132:763-86
   PubMed Web of Science ®Google Scholar
• Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 2: A generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials. 2011 (updated April 2012). Available at: http://www.nicedsu.org.uk [Last accessed 16 May 2018]
   Google Scholar
• Naganuma M, Aoyama N, Suzuki Y, et al. Twice-daily budesonide 2-mg foam induces complete mucosal healing in patients with distal ulcerative colitis. J Crohns Colitis 2016;10:828-36
   PubMed Web of Science ®Google Scholar