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

Volumn 34, Issue 3, 2016, Pages 245-257

  Essat, Munira ^a   Tappenden, Paul ^a   Ren, Shijie ^a   Bessey, Alice ^a   Archer, Rachel ^a   Wong, Ruth ^a   Lobo, Alan ^b   Hoque, Sami ^c  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^c WHIPPS CROSS UNIVERSITY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BALSALAZIDE; CALCINEURIN INHIBITOR; CORTICOSTEROID; CYCLOSPORIN; GLUCOCORTICOID; GOLIMUMAB; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MERCAPTOPURINE; MESALAZINE; PLACEBO; PREDNISOLONE; SALAZOSULFAPYRIDINE; TACROLIMUS; VEDOLIZUMAB; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ARTHRALGIA; CLINICAL EFFECTIVENESS; COLON RESECTION; COST EFFECTIVENESS ANALYSIS; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG COST; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ECONOMIC EVALUATION; EVIDENCE BASED MEDICINE; HEADACHE; HEALTH CARE ACCESS; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFUSION RELATED REACTION; MAINTENANCE THERAPY; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REMISSION; REVIEW; RHINOPHARYNGITIS; TREATMENT DURATION; ULCERATIVE COLITIS; UPPER RESPIRATORY TRACT INFECTION; ANTAGONISTS AND INHIBITORS; COLITIS, ULCERATIVE; COST BENEFIT ANALYSIS; DRUG APPROVAL; ECONOMICS; QUALITY OF LIFE; UNITED KINGDOM;

ANTIBODIES, MONOCLONAL, HUMANIZED; COLITIS, ULCERATIVE; COST-BENEFIT ANALYSIS; DRUG APPROVAL; HUMANS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TUMOR NECROSIS FACTOR-ALPHA; UNITED KINGDOM;

EID: 84959108457     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-015-0334-3     Document Type: Review

References (42)

1. National Institute for Health and Care Excellence (NICE). Guide to the processes of technology appraisal. London: NICE; 2014.
2. Essat M, Tappenden P, Ren S, et al. Vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis: a single technology appraisal. Sheffield: University of Sheffield; 2014. http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/133951/ERGReport-13-110-01.pdf. Accessed 28 Sept 2015.
3. National Institute for Health and Care Excellence (NICE). Vedolizumab for treating moderately to severely ulcerative colitis: evaluation report. London: NICE; 2015.
4. Burness C, Keating G. Adalimumab: a review of its use in the treatment of patients with ulcerative colitis. BioDrugs. 2013;27(3):247–62.
5. Kornbluth A, Sachar D. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501–23.
6. Reinisch W, Sandborn W, Bala M, et al. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis. Inflamm Bowel Dis. 2007;13(9):1135–40.
7. Danese S, Fiocchi C, America N. Ulcerative colitis. N Engl J Med. 2011;365:1713–25.
8. National Institute for Health and Care Excellence (NICE). Clinical guideline 166. Ulcerative colitis: management in adults, children and young people. London: NICE; 2013.
9. Dignass A, Lindsay J, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohn’s Colitis. 2012;6(10):991–1030.
10. Irvine E. Review article: patients’ fears and unmet needs in inflammatory bowel disease. Aliment Pharmacol Ther. 2004;20(Suppl 4):54–9.
11. 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(4):431–40.
12. European Medicines Agency (EMA). Entyvio: European public assessment report. London: EMA; 2014.
13. Ochsenkuhn T, D’Haens G. Current misunderstandings in the management of ulcerative colitis. Gut. 2011;60(9):1294–9.
14. McLean LP, Shea-Donohue T, Cross RK, McLean LP, Shea-Donohue T, Cross RK. Vedolizumab for the treatment of ulcerative colitis and Crohn’s disease. Immunotherapy. 2012;4(9):883–98.
15. Beaugerie L, Brousse N, Bouvier AM, et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet. 2009;374(9701):1617–25.
16. European Medicines Agency (EMA). Vedolizumab: European public assessment report. London: EMA; 2014.
17. National Institute for Health and Care Excellence (NICE). Vedolizumab for the treatment of adults with moderate to severe ulcerative colitis: single technology appraisal. Final scope. London: NICE; 2014.
18. Takeda Pharmaceuticals. Vedolizumab (Entyvio) for the treatment of adults with moderate to severe ulcerative colitis. Manufacturer’s submission to the National Institute for Health and Care Excellence. High Wycombe: Takeda; 2014.
19. 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.
20. Millennium Pharmaceuticals, Inc. Long term safety of vedolizumab (MLN0002) in patients with ulcerative colitis and Crohn’s disease (ClinicalTrials.gov identifier NCT00619489). ClinicalTrials.gov. 2014. http://www.ClinicalTrials.gov. Accessed 28 Sept 2015.
21. Colombel J, Sands B, et al. OP359: long term safety of vedolizumab for the treatment of ulcerative colitis and Crohn’s disease (abstract no. OP359). Berlin: United European Gastroenterology Week; 2013.
22. Colombel J, Sands BE, et al. Long term safety of vedolizumab for the treatment of ulcerative colitis or Crohn’s disease (oral presentation). Berlin: United European Gastroenterology Week; 2013.
23. Colombel JF, Sands BE, Feagan BG, et al. Integrated safety analysis of vedolizumab for the treatment of ulcerative colitis or Crohn’s disease. Gastroenterology. 2013;144(5 Suppl 1):S113.
24. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011;60(6):780–7.
25. Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257–65. (e1–3).
26. 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.
27. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85–95.
28. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:96–109.
29. Suzuki Y, Motoya S, Hanai H, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol. 2014;49(2):283–94.
30. National Institute for Health and Care Excellence (NICE). Single technology appraisal (STA)—specification for manufacturer/sponsor submission of evidence. London: NICE; 2009.
31. National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. London: NICE; 2013.
32. European Medicines Agency (EMA). Adalimumab: summary of product characteristics. London: EMA; 2014.
33. European Medicines Agency (EMA). Golimumab: summary of product characteristics. London: EMA; 2014.
34. European Medicines Agency (EMA). Infliximab: summary of product characteristics. London: EMA; 2014.
35. European Medicines Agency (EMA). Vedolizumab: summary of product characteristics. London: EMA; 2014.
36. Loftus EV, Delgado DJ, Friedman HS, Sandborn WJ. Colectomy and the incidence of postsurgical complications among ulcerative colitis patients with private health insurance in the United States. Am J Gastroenterol. 2008;103:1737–45.
37. Mahadevan U, Loftus EV, Tremaine WJ, et al. Azathioprine or 6-mercaptopurine before colectomy for ulcerative colitis is not associated with increased postoperative complications. Inflamm Bowel Dis. 2002;8(5):311–6.
38. Arai K, Koganei K, Kimura H, et al. Incidence and outcome of complications following restorative proctocolectomy. Am J Surg. 2005;190:39–42.
39. Swinburn P, Elwick H, Bean K, et al. The impact of surgery on health related quality of life in ulcerative colitis. Gut. 2012;61:A237.
40. Woehl A, Hawthorne A, McEwan P. The relation between disease activity, quality of life and health utility in patients with ulcerative colitis. Gut. 2008;57(Suppl 1):A153.
41. National Institute for Health and Care Excellence (NICE). Vedolizumab for treating moderately to severely ulcerative colitis (ID691): final determination document. London: NICE; 2015.
42. Buchanan J, Wordsworth S, Ahmad T, et al. Managing the long term care of inflammatory bowel disease patients: the cost to European health care providers. J Crohn’s Colitis. 2011;5:301–16.