A systematic review of the cost-effectiveness of biologics for the treatment of inflammatory bowel diseases

PLoS ONE

Volumn 10, Issue 12, 2015, Pages

  Huoponen, Saara ^a   Blom, Marja ^a  

^a UNIVERSITY OF HELSINKI   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFLAMMATORY AGENT; BIOLOGICAL PRODUCT;

COST BENEFIT ANALYSIS; ECONOMICS; HUMAN; INFLAMMATORY BOWEL DISEASES; META ANALYSIS;

ANTI-INFLAMMATORY AGENTS; BIOLOGICAL PRODUCTS; COST-BENEFIT ANALYSIS; HUMANS; INFLAMMATORY BOWEL DISEASES;

EID: 84956662290     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0145087     Document Type: Article

References (69)

1. Dignass A, Eliakim R, Magro F, Maaser C, Chowers Y, Geboes K, et al. Second European evidencebased consensus on the diagnosis and management of ulcerative colitis part 1: Definitions and diagnosis. J Crohns Colitis. 2012; 6: 965-990. doi: 10.1016/j.crohns.2012.09.003 PMID: 23040452.
2. Van Assche G, Dignass A, Panes J, Beaugerie L, Karagiannis J, Allez M, et al. The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Definitions and diagnosis. J Crohns Colitis. 2010; 4: 7-27. doi: 10.1016/j.crohns.2009.12.003 PMID: 21122488.
3. Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142: 46-54. doi: 10.1053/j.gastro.2011.10.001 PMID: 22001864.
4. Burisch J, Jess T, Martinato M, Lakatos PL. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013; 7: 322-337. doi: 10.1016/j.crohns.2013.01.010 PMID: 23395397.
5. Dignass A, Van Assche G, Lindsay JO, Lémann M, Söderholm J, Colombel JF, et al. The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis. 2010; 4: 28-62. doi: 10.1016/j.crohns.2009.12.002 PMID: 21122489.
6. Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel J-F, Allez M, et al. Second European evidencebased consensus on the diagnosis and management of ulcerative colitis part 2: Current management. J Crohns Colitis. 2012; 6: 991-1030. doi: 10.1016/j.crohns.2012.09.002 PMID: 23040451.
7. Øresland T, Bemelman WA, Sampietro GM, Spinelli A, Windsor A, Ferrante M, et al. European evidence-based consensus on surgery for ulcerative colitis. J Crohns Colitis. 2015; 9: 4-25. doi: 10.1016/j.crohns.2014.08.012 PMID: 25304060.
8. Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: Systematic review and meta-analysis. Am J Gastroenterol. 2011; 106: 644-659. doi: 10.1038/ajg.2011.73 PMID: 21407183.
9. European Medicines Agency; 2015. Database: European public assessment reports [Internet]. Accessed: Http://www.ema.europa.eu/ema/index.jsp?curl = pages/medicines/landing/epar-search. jsp&mid=WC0b01ac058001d124.
10. U.S. Food and Drug Administration; 2015. Database: Drugs@FDA. FDA Approved Drug Products [Internet]. Accessed: Http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
11. Odes S, Vardi H, Friger M, Wolters F, Russel MG, Riis L, et al. Cost analysis and cost determinants in a European inflammatory bowel disease inception cohort with 10 years of follow-up evaluation. Gastroenterology. 2006; 131: 719-728. doi: 10.1053/j.gastro.2006.05.052 PMID: 16952541.
12. Van Der Valk ME, Mangen M-JJ, Leenders M, Dijkstra G, Van Bodegraven AA, Fidder HH, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNF? therapy: Results from the COIN study. Gut. 2014; 63: 72-79. doi: 10.1136/gutjnl-2012-303376 PMID: 23135759.
13. Frolkis AD, Dykeman J, Negrón ME, Debruyn J, Jette N, Fiest KM, et al. Risk of surgery for inflammatory bowel diseases has decreased over time: A systematic review and meta-analysis of populationbased studies. Gastroenterology. 2013; 145: 996-1006. doi: 10.1053/j.gastro.2013.07.041 PMID: 23896172.
14. Lichtenstein GR, Hanauer SB, Sandborn WJ. Management of Crohn's disease in adults. Am J Gastroenterol. 2009; 104: 465-483. doi: 10.1038/ajg.2008.168 PMID: 19174807.
15. Lv R, Qiao W, Wu Z, Wang Y, Dai S, Liu Q, et al. Tumor necrosis factor alpha blocking agents as treatment for ulcerative colitis intolerant or refractory to conventional medical therapy: A meta-analysis. PLoS One. 2014; 9: E86692. doi: 10.1371/journal.pone.0086692 PMID: 24475168.
16. Lawson M, Thomas A, Akobeng A. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006; 1-29.
17. Danese S, Vuitton L, Peyrin-Biroulet L. Biologic agents for IBD: Practical insights. Nat Rev Gastroenterol Hepatol 2015. 12: 537-545. doi: 10.1038/nrgastro.2015.135 PMID: 26284562.
18. Tang DH, Harrington AR, Lee JK, Lin M, Armstrong EP. A systematic review of economic studies on biological agents used to treat Crohn's disease. Inflamm Bowel Dis. 2013; 19: 2673-2694. doi: 10. 1097/MIB.0b013e3182916046 PMID: 23792552.
19. Marshall J, Blackhouse G, Goeree R, Brazier N, Irvine E, Faulkner L, et al. Infliximab for the treatment of Crohn's disease: A systematic review and cost-utility analysis [Technology report no 24]. Ottawa: Canadian Coordinating Office for Health Technology Assessment (CCOHTA). 2002. Available: Https://www.cadth.ca/sites/default/files/pdf/122-infliximab-tr-e.pdf. Accessed 1 July 2015.
20. Fleurence R, Spackman E. Cost-effectiveness of biologic agents for treatment of autoimmune disorders: Structured review of the literature. J Rheumatol. 2006; 33: 2124-2131.
21. Dretzke J, Edlin R, Round J, Connock M, Hulme C, Czeczot J, et al. A systematic review and economic evaluation of the use of tumour. Health Technol Assess. 2011; 15: 1-252. doi: 10.3310/hta15060 PMID: 21291629.
22. Assasi N, Blackhouse G, Xie F, Gaebel K, Marshall J, Irvine EJ, et al. Anti-TNF-alfa drugs for refractory inflammatory bowel disease: Clinical-and cost-effectiveness analyses [Technology Report no 120]. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2009. Available: Https://www.cadth.ca/media/pdf/H0479-Anti-TNF-a-Drugs-for-Refractory-Inflammatory-Bowel-Disease-tr-e.pdf. Accessed 1 July 2015.
23. Torrance G, Siegel J, Luce B. Framing and Designing the Cost-Effectiveness Analysis. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. New York: Oxford University of Press; 1996. pp. 54-81.
24. Drummond MF, Sculpher MJ, Torrance GW, ÓBrien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. 3rd ed. New York: Oxford University Press; 2005.
25. Gold M, Patrick D, Torrance G, Fryback D, Hadorn D, Kamlet M, et al. Identifying and Valuing Outcomes. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. New York: Oxford University of Press; 1996. pp. 82-134.
26. Luce B, Manning W, Siegel J, Lipscomb J. Estimating Costs in Cost-Effectiveness Analysis. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. New York: Oxford University of Press; 1996. pp. 176-213.
27. Methods Guide for Medical Test Reviews. AHRQ Publication no 12-EC017. Rockville: Agency for Healthcare Research and Quality; 2012. Available: Http://www.effectivehealthcare.ahrq.gov/ehc/products/246/558/Methods-Guide-for-Medical-Test-Reviews-Full-Guide-20120530.pdf. Accessed 1 July 2015.
28. Shemilt I, Mugford M, Byford S, Drummond M, Eisenstein E, Knapp M, et al. Chapter 15: Incorporating economics evidence. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions; 2008. pp. 447-479.
29. Craig D, Rice S. NHS Economic Evaluation Database Handbook. 3rd ed. York: Centre for Reviews and Dissemination, University of York; 2007.
30. European Central Bank. Bilateral Exchange rates; 2015. Database: Statistical Data Warehouse [Internet]. Accessed: Https://sdw.ecb.europa.eu/browse.do?node=2018794.
31. Official Statistics of Finland. Value of Money 1860-2014. Database: Consumer price index 2014 [Internet]. Helsinki, Finland: Satatistics of Finalnd; 2014. Acessed: Http://www.stat.fi/til/khi/2014/khi-2014-2015-01-19-tau-001.html.
32. Drummond M, Jefferson T. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ. 1996; 313: 275-283. doi: 10.1136/bmj.313.7052.275 PMID: 8704542.
33. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)-explanation and elaboration: A report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013; 16: 231-250. doi: 10.1016/j.jval.2013.02.002 PMID: 23538175.
34. Philips Z, Ginnelly L, Sculpher M, Claxton K. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004; 8: 1-172.
35. Punekar YS, Hawkins N. Cost-effectiveness of infliximab for the treatment of acute exacerbations of ulcerative colitis. Eur J Health Econ. 2010; 11: 67-76. doi: 10.1007/s10198-009-0199-5 PMID: 19844750.
36. Chaudhary MA, Fan T. Cost-Effectiveness of Infliximab for the Treatment of Acute Exacerbations of Ulcerative Colitis in the Netherlands. Biol Ther. 2013; 3: 45-60. doi: 10.1007/s13554-012-0007-0 PMID: 24392304.
37. Bryan S, Andronis L, Hyde C, Connock M, Fry-Smith A, Wang D. Infliximab for the treatment of acute exacerbations of ulcerative colitis. Evidence Review Group Report commissioned by the NHS R&D HTA Programme on behalf of NICE. 2008:1-120. Available: Http://www.nets.nihr.ac.uk/-data/assets/pdf-file/0019/82513/ERGReport-08-37-01.pdf. Accessed 1 July 2015.
38. Hyde C, Bryan S, Biddle K, Massey A. Infliximab for ulcerative colitis. Evidence Review Group Report commissioned by the NHS R&D HTA Programme on behalf of NICE. 2007:1-113. Available: Http://www.nets.nihr.ac.uk/-data/assets/pdf-file/0003/82506/ERGReport-07-12-01.pdf. Accessed 1 July 2015.
39. Ananthakrishnan AN, Hur C, Juillerat P, Korzenik JR. Strategies for the prevention of postoperative recurrence in Crohn's disease: Results of a decision analysis. Am J Gastroenterol. 2011; 106: 2009-2017. doi: 10.1038/ajg.2011.237 PMID: 21788991.
40. Ananthakrishnan AN, Hur C, Korzenik JR. Certolizumab pegol compared to natalizumab in patients with moderate to severe Crohn's disease: Results of a decision analysis. Dig Dis Sci. 2012; 57: 472-480. doi: 10.1007/s10620-011-1896-3 PMID: 21909990.
41. Arseneau KO, Cohn SM, Cominelli F, Connors AF. Cost-utility of initial medical management for Crohn's disease perianal fistulae. Gastroenterology. 2001; 120: 1640-1656.
42. 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-? drugs for refractory Crohn's disease. J Crohns Colitis. 2012; 6: 77-85. doi: 10.1016/j.crohns.2011.07.007 PMID: 22261531.
43. 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: 265-274. doi: 10.1111/j.1365-2036.2009.04033.x PMID: 19438428.
44. Clark W, Raftery J, Song F, Barton P, Cummins C, Fry-Smith A, et al. Systematic review and economic evaluation of the effectiveness of infliximab for the treatment of Crohn's disease. Health Technol Assess. 2003; 7: 1-80. PMID: 12709295.
45. Doherty G, Miksad R, Cheifetz A, Moss A. Comparative cost-effectiveness of strategies to prevent postoperative clinical recurrence of Crohn's disease. Inflamm Bowel Dis.2012; 18: 1608-1616. doi: 10.1002/ibd.21904
46. Jaisson-hot I, Flourie B, Descos L, Colin C. Management for severe Crohn's disease : A lifetime costutility analysis. Int J Technol Assess Health Care. 2004; 20: 274-279.
47. Kaplan GG, Hur C, Korzenik J, Sands BE. Infliximab dose escalation vs. initiation of adalimumab for loss of response in Crohn's disease: A cost-effectiveness analysis. Aliment Pharmacol Ther. 2007; 26: 1509-1520. doi: 10.1111/j.1365-2036.2007.03548.x PMID: 17931345.
48. Lindsay J, Punekar YS, 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: 76-87.
49. Loftus E V, Johnson SJ, Yu AP, Wu EQ, Chao J, Mulani PM. Cost-effectiveness of adalimumab for the maintenance of remission in patients with Crohn's disease. Eur J Gastroenterol Hepatol. 2009; 21: 1302-1309. doi: 10.1097/MEG.0b013e32832a8d71 PMID: 19465858.
50. Marchetti M, Liberato NL, Di Sabatino A, Corazza GR. Cost-effectiveness analysis of top-down versus step-up strategies in patients with newly diagnosed active luminal Crohn's disease. Eur J Heal Econ. 2013; 14: 853-861. doi: 10.1007/s10198-012-0430-7 PMID: 22975794.
51. Saito S, Shimizu U, Nan Z, Mandai N, Yokoyama J, Terajima K, et al. Economic impact of combination therapy with infliximab plus azathioprine for drug-refractory Crohn's disease: A cost-effectiveness analysis. J Crohns Colitis. 2013; 7: 167-174.
52. Tang DH, Armstrong EP, Pharm D, Lee JK. Cost-Utility Analysis of Biologic Treatments for Moderateto-Severe Crohn's Disease. Pharmacotherapy. 2012; 32: 515-526. doi: 10.1002/j.1875-9114.2011. 01053.x PMID: 22528603.
53. Tsai HH, Punekar YS, Morris J, Fortun P. 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: 1230-1239.
54. Ung V, Thanh NX, Wong K, Kroeker KI, Lee T, Wang H, et al. Real-life Treatment Paradigms Show Infliximab Is Cost-effective for Management of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2014; 12: 1871-1878. doi: 10.1016/j.cgh.2014.03.012 PMID: 24674943.
55. Xie F, Blackhouse G, Assasi N, Gaebel K, Robertson D, Goeree R. Cost-utility analysis of infliximab and adalimumab for refractory ulcerative colitis. Cost Eff Resour Alloc. 2009; 7: 1-8. doi: 10.1186/1478-7547-7-20 PMID: 20003364.
56. Yu AP, Johnson S, Wang S, Atanasov P, Tang J, Wu E, et al. Cost Utility of Adalimumab versus Infliximab Maintenance Therapies in the United States for Moderately to Severely Active Crohn's Disease. 2009; 27: 609-621. doi: 10.2165/11312710-000000000-00000 PMID: 19663531.
57. Casellas F, Arenas JI, Baudet JS, Fa S, Gelabert J, Medina C, et al. Impairment of Health-related Quality of Life in Patients with Inflammatory Bowel Disease: A Spanish Multicenter Study. Inflamm Bowel Dis. 2005; 11: 488-496. PMID: 15867589.
58. Gregor J, McDonald J, Klar N, Wall R, Atkinson K, Lamba B, et al. An evaluation of utility measurement in Crohn's disease. Inflamm Bowel Dis. 1997; 3: 265-276. PMID: 23282873
59. Buxton M, Lacey L, Feagan B, Niecko T, Miller D, Townsend R. Mapping from disease-specific measures to utility: An analysis of the relationships between the Inflammatory Bowel Disease Questionnaire and Crohn's Disease Activity Index in Crohn's disease and measures of utility. Value Heal. 2007; 10: 214-220. doi: 10.1111/j.1524-4733.2007.00171.x PMID: 17532814.
60. Paul D. Modeling Valuations for EuroQol Health States. Med Care. 1997; 35: 1095-1108.
61. Arseneau KO, Sultan S, Provenzale DT, Onken J, Bickston SJ, Foley E, et al. Do patient preferences influence decisions on treatment for patients with steroid-refractory ulcerative colitis? Clin Gastroenterol Hepatol. 2006; 4: 1135-1142.
62. National Institute for Health and Care Excellence [Internet]. Guide to the methods of technology appraisal 2013. 2013. Available: Http://publications.nice.org.uk/guide-to-the-methods-of-technologyappraisal-2013-pmg9. Accessed 1 July 2015.
63. Rocchi A, Menon D, Verma S, Miller E. The Role of Economic Evidence in Canadian Oncology Reimbursement Decision-Making: To Lambda and Beyond. Value Heal. 2008; 11: 771-783. doi: 10.1111/j. 1524-4733.2007.00298.x PMID: 18179658.
64. Shiroiwa T, Sung Y, Fukuda T, Lang H. International Survey on Willingness-to-Pay (WTP) for one Additional QALY Gained: What is the Threshold of Cost Effectiveness? Health Econ. 2010; 437: 422-437.
65. Kaplan RM, Bush JW. Health-Related Quality of Life Measurement for Evaluation Research and Policy Analysis. Heal Psychol. 1982; 1: 61-80.
66. World Health Organisation [Internet]. Cost-Effectiveness thresholds. 2015. Available: Http://www.who. int/choice/costs/CER-thresholds/en/. Accessed 1 July 2015.
67. Lichtenstein GR, Yan S, Bala M, Hanauer S. Remission in Patients with Crohn's Disease is Associated with Improvement in Employment and Quality of Life and a Decrease in Hospitalizations and Surgeries. Am J Gastroenterol. 2004; 99:91-96.
68. European Network for Health Technology Assessment (EUnetHTA) [Internet]. Criteria for the choice choice of the most appropriate comparator(s). Summary of current policies and best practice recommendations. February, 2013. Available: Http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Choice-of-comparator.pdf. Accessed 1 July 2015.
69. Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions; 2008. pp. 187-241.