Pharmacoeconomic evaluation. In: CDR submission: Stelara (ustekinumab), solution for infusion 130 mg/26 mL, 90 mg/1.0 mL solution for injection. Company: Janssen Inc. [CONFIDENTIAL manufacturer’s submission]. Toronto (ON): Janssen Inc.; 2016 Sep 12.

Common Drug Review. CADTH Canadian Drug Expert Review Committee (CDEC) final recommendation: Ustekinumab (Stelara - Janssen Inc.). Indication: psoriatic arthritis [Internet]. Ottawa (ON): CADTH; 2014 Oct 20. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_SR0359_Stelara_Oct-22-14.pdf

Common Drug Review. CEDAC final recommendation and reasons for recommendation: Ustekinumab (Stelara^™ - Janssen-Ortho Inc.). Indication: chronic moderate to severe plaque psoriasis [Internet]. Ottawa (ON): CADTH; 2009 Jun 17. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_Stelara_June-17-2009.pdf

Common Drug Review. CADTH Canadian Drug Expert Committee (CDEC) final recommendation: Infliximab (Inflectra - Hospira Healthcare Corporation). Indication: Crohn disease and ulcerative colitis [Internet]. Ottawa (ON): CADTH; 2016 Oct 25. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/SE0483​_IBD_Inflectra-Oct-28-16.pdf [PubMed: 30516937]

Common Drug Review. CEDAC final recommendation and reasons for recommendation: Adalimumab resubmission #3 (Humira^® - Abbott Laboratories Ltd.) [Internet]. Ottawa (ON): CADTH; 2007. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_Humira-Resubmission-Crohns​_Dec-19-2007.pdf

Common Drug Review. CADTH Canadian Drug Expert Committee final recommendation: Vedolizumab (Entyvio - Takeda Canada Inc.). Indication: Crohn’s disease [Internet]. Ottawa (ON): CADTH; 2016 Oct 27. [cited 2016 Dec 13]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/SR0487​_complete_Entyvio-Oct-31-16.pdf

Exceptional Access Program (EAP). Drug benefit prices (DBPs) for products reimbursed under the EAP [Internet]. Toronto: Ministry of Health and Long-Term Care; 2016. [cited 2016 Nov 29]. Available from: http://www​.health.gov​.on.ca/en/pro/programs​/drugs/odbf/odbf_except_access.aspx

Gregor JC, McDonald JW, Klar N, Wall R, Atkinson K, Lamba B, et al. An evaluation of utility measurement in Crohn’s disease. Inflamm Bowel Dis. 1997;3(4):265–76. [PubMed: 23282873]

Common Drug Review. CADTH Canadian Drug Expert Committee final recommendation: Vedolizumab (Entyvio - Takeda Canada Inc.). Indication: ulcerative colitis [Internet]. Ottawa (ON): CADTH; 2015 Oct 28. [cited 2016 Dec 13]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/SR0421​_cdr_complete_Entyvio_Nov-2-15_e.pdf

Ontario drug benefit formulary/comparative drug index [Internet]. Toronto: Ministry of Health and Long-Term Care; 2016. [cited 2016 Nov 29]. Available from: https://www​.formulary​.health.gov.on.ca/formulary/

Interactive drug benefit list [Internet]. Edmonton: Alberta Health; 2016. [cited 2016 Nov 29]. Available from: https://idbl​.ab.bluecross​.ca/idbl/load.do

Cornerstone Research Group. Stelara® for the treatment of moderate to severe Crohn’s disease: network meta-analysis study report [CONFIDENTIAL internal manufacturer’s report]. Burlington (ON): Cornerstone Research Group;

Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52–65. [PubMed: 17241859]

Hanauer SB, Feagan BG, Macintosh DG, Xu J, Milch C, Fox I, et al. Efficacy of vedolizumab in crohn’s disease by prior treatment failure in Gemini II, a randomized, placebo-controlled, double-blind, multicenter study. Gastroenterology [Internet]. 2013 May [cited 2016 Dec 19];144(5 suppl 1):S772. Available from: http://www​.gastrojournal​.org/article/S0016-5085(13)62854-1​/pdf

Clinical study report CNTO1275CRD3003. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Clinical study report CNTO1275CRD3001. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease who have failed or are intolerant to TNF antagonist therapy [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Clinical study report CNTO1275CRD3002. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541–9. [PubMed: 12047962]

Greenberg D, Schwartz D, Vardi H, Friger M, Sarid O, Slonim-Nevo V, et al. Health-related utility weights in a cohort of real-world Crohn’s disease patients. J Crohns Colitis. 2015 Dec;9(12):1138–45. [PubMed: 26374662]

Soini EJ, Leussu M, Hallinen T. Administration costs of intravenous biologic drugs for rheumatoid arthritis. Springerplus [Internet]. 2013 [cited 2016 Dec 19];2:531. Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC3825225 [PMC free article: PMC3825225] [PubMed: 24255834]

Schedule of benefits: physician services under the Health Insurance Act [Internet]. Toronto: Ministry of Health and Long Term Care; 2015. [cited 2016 Dec 13]. Available from: http://www​.health.gov​.on.ca/en/pro/programs​/ohip/sob/physserv​/sob_master11062015.pdf

Schedule of benefits for laboratory services. Toronto: Ministry of Health and Long Term Care; 2016.

Loftus EV, Augustin M, Bissonnette R, Krueger G, Calabro S, Langholff W. Prevalence of inflammatory bowel disease among patients with psoriasis and incidence of serious infections in this subset: results from the PSOLAR registry [abstract]. Gastroenterology. 2016;150(4 Suppl):S805.

Bernstein CN, Loftus EV, Jr., Ng SC, Lakatos PL, Moum B, Epidemiology and Natural History Task Force of the International Organization for the Study of Inflammatory Bowel Disease (IOIBD). Hospitalisations and surgery in Crohn’s disease. Gut. 2012 Apr;61(4):622–9. [PubMed: 22267595]

Chaparro M, Panes J, Garcia V, Merino O, Nos P, Domenech E, et al. Long-term durability of response to adalimumab in Crohn’s disease. Inflamm Bowel Dis. 2012 Apr;18(4):685–90. [PubMed: 21618353]

Molander P, Farkkila M, Salminen K, Kemppainen H, Blomster T, Koskela R, et al. Outcome after discontinuation of TNFalpha-blocking therapy in patients with inflammatory bowel disease in deep remission. Inflamm Bowel Dis. 2014 Jun;20(6):1021–8. [PubMed: 24798636]

Clinical and economic assessment: infliximab for the treatment of Crohn’s disease [Internet]. Ottawa: CADTH; 2002. [cited 2016 Dec 13]. (Technology overview; no.8). Available from: https://www​.cadth.ca​/clinical-and-economic-assessment-infliximab-treatment-crohns-disease-0

Blackhouse G, Assasi N, Xie F, Marshall J, Irvine EJ, Gaebel K, et al. Canadian cost-utility analysis of initiation and maintenance treatment with anti-TNF-alpha drugs for refractory Crohn’s disease. J Crohns Colitis. 2012 Feb;6(1):77–85. [PubMed: 22261531]

Assasi N, Blackhouse G, Xie F, Gaebel K, Marshall J, Irvine E. Anti-TNF-a drugs for refractory inflammatory bowel disease: clinical-and cost-effectiveness analyses. Ottawa: CADTH; 2009.