The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries

Advances in Therapy

Volumn 32, Issue 8, 2015, Pages 742-756

  Jha, Ashok ^a   Upton, Alex ^b   Dunlop, William C N ^a   Akehurst, Ron ^c,d  

^a Mundipharma   (United Kingdom)

^b Decision Resources Group   (United Kingdom)

^c UNIVERSITY OF SHEFFIELD   (United Kingdom)

^d BRESMED   (United Kingdom)

Author keywords

Ankylosing spondylitis; Biosimilar; Crohn s disease; Infliximab; Psoriasis; Psoriatic arthritis; Remicade ; Remsima ; Rheumatoid arthritis; Ulcerative colitis

Indexed keywords

INFLIXIMAB; ANTIRHEUMATIC AGENT; BIOSIMILAR AGENT; CT-P13; MONOCLONAL ANTIBODY;

ANKYLOSING SPONDYLITIS; ARTICLE; AUTOIMMUNE DISEASE; BELGIUM; BUDGET; COST CONTROL; CROHN DISEASE; DRUG COST; ECONOMIC EVALUATION; GERMANY; HUMAN; INCIDENCE; ITALY; LOADING DRUG DOSE; NETHERLANDS; PREVALENCE; PSORIASIS; PSORIATIC ARTHRITIS; RHEUMATOID ARTHRITIS; ULCERATIVE COLITIS; UNITED KINGDOM; AGED; ARTHRITIS, PSORIATIC; ARTHRITIS, RHEUMATOID; ECONOMICS; EUROPE; FEE; FEMALE; MALE; PROCEDURES; SPONDYLITIS, ANKYLOSING; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA;

AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, PSORIATIC; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; COST SAVINGS; DRUG COSTS; EUROPE; FEMALE; HUMANS; INFLIXIMAB; MALE; MODELS, ECONOMETRIC; PRESCRIPTION FEES; SPONDYLITIS, ANKYLOSING;

EID: 84941878057     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-015-0233-1     Document Type: Article

References (60)

1. Uhlig T, Loge JH, Kristiansen IS, Kvien TK. Quantification of reduced health-related quality of life in patients with rheumatoid arthritis compared to the general population. J Rheumatol. 2007;34:1241–7.
2. Boonen A, Mau W. The economic burden of disease: comparison between rheumatoid arthritis and ankylosing spondylitis. Clin Exp Rheumatol. 2009;27(Suppl 55):S112–7.
3. Nordin K, Pahlman L, Larsson K, Sundberg-Hjelm M, Loof L. Health-related quality of life and psychological distress in a population-based sample of Swedish patients with inflammatory bowel disease. Scand J Gastroenterol. 2002;37:450–7.
4. Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41:401–7.
5. Rosen CF, Mussani F, Chandran V, et al. Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone. Rheumatol (Oxf). 2012;51:571–6.
6. Lundkvist J, Kastang F, Kobelt G. The burden of rheumatoid arthritis and access to treatment: health burden and costs. Eur J Health Econ. 2008;8(Suppl. 2):S49–60.
7. Franke LC, Ament AJ, van de Laar MA, Boonen A, Severens JL. Cost-of-illness of rheumatoid arthritis and ankylosing spondylitis. Clin Exp Rheumatol. 2009;27(Suppl. 55):S118–23.
8. 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 Crohns Colitis. 2011;5:301–16.
9. Fonia A, Jackson K, Lereun C, et al. A retrospective cohort study of the impact of biologic therapy initiation on medical resource use and costs in patients with moderate to severe psoriasis. Br J Dermatol. 2010;163:807–16.
10. Kennedy M, Papneja A, Thavaneswaran A, Chandran V, Gladman DD. Prevalence and predictors of reduced work productivity in patients with psoriatic arthritis. Clin Exp Rheumatol. 2014;32:342–8.
11. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509.
12. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904.
13. Dignass A, Van Assche G, Lindsay JO, 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.
14. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012;6:991–1030.
15. National Institute for Health and Care Excellence. CG153: Psoriasis: the assessment and management of psoriasis. 2012. http://publications.nice.org.uk/psoriasis-cg153. Accessed 02 Feb 2015.
16. Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012;71:4–12.
17. Kobelt G, Eberhardt K, Geborek P. TNF inhibitors in the treatment of rheumatoid arthritis in clinical practice: costs and outcomes in a follow up study of patients with RA treated with etanercept or infliximab in southern Sweden. Ann Rheum Dis. 2004;63:4–10.
18. Machado MA, Barbosa MM, Almeida AM, et al. Treatment of ankylosing spondylitis with TNF blockers: a meta-analysis. Rheumatol Int. 2013;33:2199–213.
19. Nielsen OH, Ainsworth MA. Tumor necrosis factor inhibitors for inflammatory bowel disease. N Engl J Med. 2013;369:754–62.
20. Yost J, Gudjonsson JE. The role of TNF inhibitors in psoriasis therapy: new implications for associated comorbidities. F1000 Med Rep. 2009;1:30.
21. Merck Sharp and Dohme Ltd. Remicade. Summary of product information. http://www.medicines.org.uk/emc/medicine/3236/SPC/Remicade+100mg+powder+for+concentrate+for+solution+for+infusion/. Accessed 28 July 2015.
22. Blumenauer B, Judd M, Wells G, et al. Infliximab for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2002;CD003785. doi:10.1002/14651858.CD003785/abstract.
23. Toussirot E, Bertolini E, Wendling D. Management of ankylosing spondylitis with infliximab. Open Access Rheumatol Res Rev. 2009;1:69–82.
24. Kawalec P, Mikrut A, Wisniewska N, Pilc A. Tumor necrosis factor-alpha antibodies (infliximab, adalimumab and certolizumab) in Crohn’s disease: systematic review and meta-analysis. Arch Med Sci. 2013;9:765–79.
25. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;CD005112. doi:10.1002/14651858.CD005112.pub2/abstract.
26. Mustafa A, Al-Hoqail I. Biologic systemic therapy for moderate-to-severe psoriasis: a review. J Taibah Uni Med Sci. 2013;8:142–50.
27. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf. Accessed 28 July 2015.
28. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. Accessed 28 July 2015.
29. US Food and Drug Administration. FDA issues draft guidance on biosimilar product development. 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm. Accessed 28 July 2015.
30. European Medicines Agency. Remsima: European Public Assessment Report—summary for the public. 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002576/human_med_001682.jsp&mid=WC0b01ac058001d124. Accessed 28 July 2015.
31. European Medicines Agency. European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars. Press release. 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001837.jsp&mid=WC0b01ac058004d5c1. Accessed 28 July 2015.
32. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613–20.
33. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605–12.
34. Park W, Jaworski J, Brzezicki J, et al. A randomized, double-blind, parallel-group, phase I study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54-week results from the PLANETAS study. Poster presented at EULAR 2013b, Madrid, 12–15 June.
35. Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Poster #L15 presented at the ACR/ARHP 2013 Annual Meeting, Oct 2013, San Diego, 2013c.
36. Yoo DH, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Poster #L1 presented at the ACR/ARHP 2013 Annual Meeting, Oct 2013, San Diego, 2013c.
37. Yoo DH, Racewicz A, Brzezicki J, et al. A Phase III, randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Ann Rheum Dis. 2013;72(Suppl. 3):A73.
38. Huscher D, Mittendorf T, von Hinuber U, et al. Evolution of cost structures in rheumatoid arthritis over the past decade. Ann Rheum Dis. 2015;74:738–45.
39. Gissel C, Repp H. Cost per responder of TNF-alpha therapies in Germany. Clin Rheumatol. 2013;32:1805–9.
40. Kobelt G, Andlin-Sobocki P, Brophy S, et al. The burden of ankylosing spondylitis and the cost-effectiveness of treatment with infliximab (Remicade). Rheumatol (Oxf). 2004;43:1158–66.
41. Yang M, et al. Cost-effectiveness of Adalimumab for treatment of Crohn’s disease in Germany. 15th Annual European Conference of the International Society for Pharmacoeconomics and Outcomes Research: abstract. PGI20, 3 Nov 2012.
42. 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.
43. de Portu S, Del Giglio M, Altomare G, et al. Cost-effectiveness analysis of TNF-alpha blockers for the treatment of chronic plaque psoriasis in the perspective of the Italian health-care system. Dermatol Ther. 2010;23(Suppl. 1):S7–13.
44. Cummins E, Asseburg C, Punekar YS, et al. Cost-effectiveness of infliximab for the treatment of active and progressive psoriatic arthritis. Value Health. 2011;14:15–23.
45. Kobelt G, Jonsson L, Young A, Eberhardt K. The cost-effectiveness of infliximab (Remicade) in the treatment of rheumatoid arthritis in Sweden and the United Kingdom based on the ATTRACT study. Rheumatol Oxf. 2003;42:326–35.
46. Olivieri I, de Portu S, Salvarani C, et al. The psoriatic arthritis cost evaluation study: a cost-of-illness study on tumour necrosis factor inhibitors in psoriatic arthritis patients with inadequate response to conventional therapy. Rheumatol (Oxf). 2008;47:1664–70.
47. Brodszky V, Baji P, Balogh O, Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl. 1):S65–71.
48. United Nations. Department of Economic and Social Affairs. Population division, population estimates and projections section. 2012. http://esa.un.org/unpd/wpp/unpp/panel_population.htm. Accessed 28 July 2015.
49. Kay LJ, Griffiths ID. UK consultant rheumatologists’ access to biological agents and views on the BSR Biologics Register. Rheumatol (Oxf). 2006;45:1376–9.
50. Z-Index B.V. 2014. https://www.z-index.nl/. Accessed 28 July 2015.
51. Economou M, Zambeli E, Michopoulos S. Incidence and prevalence of Crohn’s disease and its etiological influences. Ann Gastroenterol. 2009;22:158–67.
52. 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.
53. Huerta C, Rivero E, Rodriguez LA. Incidence and risk factors for psoriasis in the general population. Arch Dermatol. 2007;143:1559–65.
54. National Insitute for Health and Care Excellence. Costing statement: Golimumab for the treatment of psoriatic arthritis. 2012. http://www.nice.org.uk/guidance/ta220/resources/ta220-psoriatic-arthritis-golimumab-costing-statement2. Accessed 28 July 2015.
55. Benucci M, Cammelli E, Manfredi M, et al. Early rheumatoid arthritis in Italy: study of incidence based on a two-level strategy in a sub-area of Florence (Scandicci-Le Signe). Rheumatol Int. 2008;28:777–81.
56. Vena GA, Altomare G, Ayala F, et al. Incidence of psoriasis and association with comorbidities in Italy: a 5-year observational study from a national primary care database. Eur J Dermatol. 2010;20:593–8.
57. Donker GA, Foets M, Spreeuwenberg P, van der Werf GT. Management of psoriasis in family practice is now in closer agreement with the guidelines of the Netherlands Society of Family Physicians. Ned Tijdschr Geneeskd. 1998;142:1379–83.
58. EUMUSC. Musculoskeletal Health in Europe. Report v5.0. http://www.eumusc.net/myUploadData/files/Musculoskeletal%20Health%20in%20Europe%20Report%20v5.pdf. Accessed 28 July 2015.
59. Carbone LD, Cooper C, Michet CJ, et al. Ankylosing spondylitis in Rochester, Minnesota, 1935–1989. Is the epidemiology changing? Arthritis Rheum. 1992;35:1476–82.
60. Bakland G, Nossent HC, Gran JT. Incidence and prevalence of ankylosing spondylitis in Northern Norway. Arthritis Rheum. 2005;53:850–5.