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Erschienen in: PharmacoEconomics 10/2016

01.10.2016 | Original Research Article

A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy

verfasst von: Paul Tappenden, Shijie Ren, Rachel Archer, Rebecca Harvey, Marrissa Martyn-St James, Hasan Basarir, John Stevens, Alan Lobo, Sami Hoque

Erschienen in: PharmacoEconomics | Ausgabe 10/2016

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Abstract

Background

Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. Medical management aims to induce and maintain remission and to avoid complications and the necessity for surgical intervention. Colectomy removes the source of inflammation but is associated with morbidity and mortality. Newer anti-tumour necrosis factor (TNF)-α therapies may improve medical outcomes, albeit at an increased cost.

Objective

Our objective was to assess the incremental cost effectiveness of infliximab, adalimumab and golimumab versus conventional therapy and surgery from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a lifetime horizon.

Methods

A Markov model was developed with health states defined according to whether the patient is alive or dead, current treatments received, history of colectomy and level of disease control. Transition probabilities were derived from network meta-analyses (NMAs) of trials of anti-TNF-α agents in the moderate-to-severe UC population. Health utilities, colectomy rates, surgical complications and resource use estimates were derived from literature. Unit costs were drawn from standard costing sources and literature and were valued at year 2013/2014 values.

Results

For patients in whom surgery is an option, colectomy is expected to dominate all medical treatment options. For patients in whom colectomy is not an option, infliximab and golimumab are expected to be ruled out due to dominance, whilst the incremental cost-effectiveness ratio (ICER) for adalimumab versus conventional treatment is expected to be approximately £50,278 per quality-adjusted life-year (QALY) gained.

Conclusions

Based on the NMAs, the ICERs for anti-TNF-α therapy versus conventional treatment or surgery are expected to be at best, in excess of £50,000 per QALY gained. The cost effectiveness of withdrawing biologic therapy upon remission and re-treating relapse is unknown.
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Literatur
1.
Zurück zum Zitat National Institute for Health and Care Excellence. Ulcerative colitis: Management in adults, children and young people. NICE Clinical Guideline Number 166. London: NICE; 2013, pp 1–37. National Institute for Health and Care Excellence. Ulcerative colitis: Management in adults, children and young people. NICE Clinical Guideline Number 166. London: NICE; 2013, pp 1–37.
3.
Zurück zum Zitat Bassi A, Dodd S, Williamson P, Bodger K. Cost of illness of inflammatory bowel disease in the UK: a single centre retrospective study. Gut. 2004;53(10):1471–8.CrossRefPubMedPubMedCentral Bassi A, Dodd S, Williamson P, Bodger K. Cost of illness of inflammatory bowel disease in the UK: a single centre retrospective study. Gut. 2004;53(10):1471–8.CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Bayless TM, Hanauer SB. Advanced therapy in inflammatory bowel disease: volume 1—IBD and ulcerative colitis. 3rd ed. Shelton: Connecticut: People’s Medical Publishing House—USA; 2011. Bayless TM, Hanauer SB. Advanced therapy in inflammatory bowel disease: volume 1—IBD and ulcerative colitis. 3rd ed. Shelton: Connecticut: People’s Medical Publishing House—USA; 2011.
5.
Zurück zum Zitat Royal College of Physicians. Report of the results for the national clinical audit of adult inflammatory bowel disease inpatient care in the UK. 1-67. London: RCP; 2012, p. 1–68. Royal College of Physicians. Report of the results for the national clinical audit of adult inflammatory bowel disease inpatient care in the UK. 1-67. London: RCP; 2012, p. 1–68.
6.
Zurück zum Zitat European Medicines Agency. Summary of product characteristics—infliximab. London: EMA; 2009. p. 1–56. European Medicines Agency. Summary of product characteristics—infliximab. London: EMA; 2009. p. 1–56.
7.
Zurück zum Zitat European Medicines Agency. Summary of product characteristics—adalimumab. London: EMA; 2009. p. 1–292. European Medicines Agency. Summary of product characteristics—adalimumab. London: EMA; 2009. p. 1–292.
8.
Zurück zum Zitat European Medicines Agency. Summary of product characteristics—golimumab. London: EMA; 2009. p. 1–199. European Medicines Agency. Summary of product characteristics—golimumab. London: EMA; 2009. p. 1–199.
9.
Zurück zum Zitat Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olsen A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462–76.CrossRefPubMed Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olsen A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462–76.CrossRefPubMed
10.
Zurück zum Zitat Reinisch W, Sandborn WJ, Hommes DW, D’Haens G, Hanauer SB, Schreiber S, 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.CrossRefPubMed Reinisch W, Sandborn WJ, Hommes DW, D’Haens G, Hanauer SB, Schreiber S, 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.CrossRefPubMed
11.
Zurück zum Zitat Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D’Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257–65.CrossRefPubMed Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D’Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257–65.CrossRefPubMed
12.
Zurück zum Zitat Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85–95.CrossRefPubMed Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85–95.CrossRefPubMed
13.
Zurück zum Zitat Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):96–109.CrossRefPubMed Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):96–109.CrossRefPubMed
14.
Zurück zum Zitat Suzuki Y, Motoya S, Hanai H, Matsumoto T, Hibi T, Robinson AM, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol. 2014;49(2):283–94.CrossRefPubMed Suzuki Y, Motoya S, Hanai H, Matsumoto T, Hibi T, Robinson AM, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol. 2014;49(2):283–94.CrossRefPubMed
15.
Zurück zum Zitat Panaccione R, Ghosh S, Middleton S, Márquez JR, Scott BB, Flint L, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146(2):392–400.CrossRefPubMed Panaccione R, Ghosh S, Middleton S, Márquez JR, Scott BB, Flint L, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146(2):392–400.CrossRefPubMed
16.
Zurück zum Zitat Probert CS, Hearing SD, Schreiber S, Kühbacher T, Ghosh S, Arnott ID, et al. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial. Gut. 2003;52(7):998–1002.CrossRefPubMedPubMedCentral Probert CS, Hearing SD, Schreiber S, Kühbacher T, Ghosh S, Arnott ID, et al. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial. Gut. 2003;52(7):998–1002.CrossRefPubMedPubMedCentral
17.
Zurück zum Zitat National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. London: NICE; 2013. p. 1–102. National Institute for Health and Care Excellence. Guide to the methods of technology appraisal. London: NICE; 2013. p. 1–102.
18.
Zurück zum Zitat Archer R, Tappenden P, Ren S, Martyn St-James M, Harvey R, Basarir H et al. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy: Clinical effectiveness systematic review and economic model. Final report to the National Institute for Health and Care Excellence. Sheffield: University of Sheffield 2014, p. 1–438. Archer R, Tappenden P, Ren S, Martyn St-James M, Harvey R, Basarir H et al. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy: Clinical effectiveness systematic review and economic model. Final report to the National Institute for Health and Care Excellence. Sheffield: University of Sheffield 2014, p. 1–438.
20.
Zurück zum Zitat Woehl A, Hawthorne AB, McEwan P. The relation between disease activity, quality of life and health utility in patients with ulcerative colitis. Gut. 2008;57(Suppl1):A153. Woehl A, Hawthorne AB, McEwan P. The relation between disease activity, quality of life and health utility in patients with ulcerative colitis. Gut. 2008;57(Suppl1):A153.
21.
Zurück zum Zitat 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(9):1135–42.CrossRefPubMed 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(9):1135–42.CrossRefPubMed
22.
Zurück zum Zitat Solberg IC, Lygren I, Jahnsen J, Aadland E, Høie O, Cvancarova M, 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.CrossRefPubMed Solberg IC, Lygren I, Jahnsen J, Aadland E, Høie O, Cvancarova M, 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.CrossRefPubMed
23.
Zurück zum Zitat Arai K, Koganei K, Kimura H, Akatani M, Kitoh F, Sugita A, et al. Incidence and outcome of complications following restorative proctocolectomy. Am J Surg. 2005;190(1):39–42.CrossRefPubMed Arai K, Koganei K, Kimura H, Akatani M, Kitoh F, Sugita A, et al. Incidence and outcome of complications following restorative proctocolectomy. Am J Surg. 2005;190(1):39–42.CrossRefPubMed
25.
Zurück zum Zitat 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 Therapeut. 2008;28(10):1230–9.CrossRef 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 Therapeut. 2008;28(10):1230–9.CrossRef
26.
Zurück zum Zitat Merck, Sharp, Dohme. Manufacturer’s submission of evidence to the National Institute for Health and Care Excellence: Infliximab. Hertfordshire: MSD; 2014. Merck, Sharp, Dohme. Manufacturer’s submission of evidence to the National Institute for Health and Care Excellence: Infliximab. Hertfordshire: MSD; 2014.
28.
Zurück zum Zitat Buchanan J, Wordsworth S, Ahmad T, Perrin A, Vermeire S, Sans M, et al. Managing the long term care of inflammatory bowel disease patients: The cost to European health care providers. J Crohn Colitis. 2011;5(4):301–16.CrossRef Buchanan J, Wordsworth S, Ahmad T, Perrin A, Vermeire S, Sans M, et al. Managing the long term care of inflammatory bowel disease patients: The cost to European health care providers. J Crohn Colitis. 2011;5(4):301–16.CrossRef
29.
Zurück zum Zitat Dias S, Welton N, Sutton A, Ades A. NICE Decision Support Unit Technical Support Document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials. Sheffield: University of Sheffield; 2011. p. 1–98. Dias S, Welton N, Sutton A, Ades A. NICE Decision Support Unit Technical Support Document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials. Sheffield: University of Sheffield; 2011. p. 1–98.
30.
Zurück zum Zitat Thomas A, O’Hara B, Ligges U, Sturtz S. Making BUGS open. R News. 2015;6:12–7. Thomas A, O’Hara B, Ligges U, Sturtz S. Making BUGS open. R News. 2015;6:12–7.
32.
Zurück zum Zitat Swinburn P, Elwick H, Bean K, Curry A, Patel S, Bodger K, et al. The impact of surgery on health related quality of life in ulcerative colitis. Gut. 2012;61(Suppl2):A237. Swinburn P, Elwick H, Bean K, Curry A, Patel S, Bodger K, et al. The impact of surgery on health related quality of life in ulcerative colitis. Gut. 2012;61(Suppl2):A237.
33.
Zurück zum Zitat Van der Valk ME, Mangen MJ, Dijkstra G, Bodegraven AA, Fiddler H, De Jong DJ et al. Is there a difference in quality of life and costs between ulcerative colitis patients with a pouch or an ileostomy? Dig Dis Wk; 2012. Van der Valk ME, Mangen MJ, Dijkstra G, Bodegraven AA, Fiddler H, De Jong DJ et al. Is there a difference in quality of life and costs between ulcerative colitis patients with a pouch or an ileostomy? Dig Dis Wk; 2012.
34.
Zurück zum Zitat Richards DM, Hughes SA, Irving MH, Scott NA. Patient quality of life after successful restorative proctocolectomy is normal. Colorectal Dis. 2001;3(4):223–6.CrossRefPubMed Richards DM, Hughes SA, Irving MH, Scott NA. Patient quality of life after successful restorative proctocolectomy is normal. Colorectal Dis. 2001;3(4):223–6.CrossRefPubMed
35.
Zurück zum Zitat Kuruvilla K, Osler T, Hyman NH. A comparison of the quality of life of ulcerative colitis patients after IPAA vs ileostomy. Dis Colon Rectum. 2012;55(11):1131–7.CrossRefPubMed Kuruvilla K, Osler T, Hyman NH. A comparison of the quality of life of ulcerative colitis patients after IPAA vs ileostomy. Dis Colon Rectum. 2012;55(11):1131–7.CrossRefPubMed
36.
Zurück zum Zitat Curtis L. Unit costs of health and social care 2014. 1–294. Personal Social Services Research Unit: Kent; 2014. Curtis L. Unit costs of health and social care 2014. 1–294. Personal Social Services Research Unit: Kent; 2014.
37.
Zurück zum Zitat 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;7:20.CrossRefPubMedPubMedCentral 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;7:20.CrossRefPubMedPubMedCentral
Metadaten
Titel
A Model-Based Economic Evaluation of Biologic and Non-Biologic Options for the Treatment of Adults with Moderately-to-Severely Active Ulcerative Colitis after the Failure of Conventional Therapy
verfasst von
Paul Tappenden
Shijie Ren
Rachel Archer
Rebecca Harvey
Marrissa Martyn-St James
Hasan Basarir
John Stevens
Alan Lobo
Sami Hoque
Publikationsdatum
01.10.2016
Verlag
Springer International Publishing
Erschienen in
PharmacoEconomics / Ausgabe 10/2016
Print ISSN: 1170-7690
Elektronische ISSN: 1179-2027
DOI
https://doi.org/10.1007/s40273-016-0409-9

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