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Including Adverse Drug Events in Economic Evaluations of Anti-Tumour Necrosis Factor-α Drugs for Adult Rheumatoid Arthritis: A Systematic Review of Economic Decision Analytic Models

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Abstract

Background

Anti-tumour necrosis factor-α drugs (anti-TNFs) have revolutionised the treatment of rheumatoid arthritis (RA). More effective than standard non-biological disease-modifying anti-rheumatic drugs (nbDMARDs), anti-TNFs are also substantially more expensive. Consequently, a number of model-based economic evaluations have been conducted to establish the relative cost-effectiveness of anti-TNFs. However, anti-TNFs are associated with an increased risk of adverse drug events (ADEs) such as serious infections relative to nbDMARDs. Such ADEs will likely impact on both the costs and consequences of anti-TNFs, for example, through hospitalisations and forced withdrawal from treatment.

Objective

The aim of this review was to identify and critically appraise if, and how, ADEs have been incorporated into model-based cost-effectiveness analyses of anti-TNFs for adult patients with RA.

Methods

A systematic literature review was performed. Electronic databases (Ovid MEDLINE; Ovid EMBASE; Web of Science; NHS Economic Evaluations Database) were searched for literature published between January 1990 and October 2013 using electronic search strategies. The reference lists of retrieved studies were also hand searched. In addition, the National Institute for Health and Care Excellence technology appraisals were searched to identify economic models used to inform UK healthcare decision making. Only full economic evaluations that had used an economic model to evaluate biological DMARDs (bDMARDs) (including anti-TNFs) for adult patients with RA and had incorporated the direct costs and/or consequences of ADEs were critically appraised. To be included, studies also had to be available as a full text in English. Data extracted included general study characteristics and information concerning the methods used to incorporate ADEs and any associated assumptions made. The extracted data were synthesised using a tabular and narrative format.

Results

A total of 43 model-based economic evaluations of bDMARDs for adult RA were identified from 2,483 initially identified studies (2,473 published; ten technology appraisals). Of these, nine studies had incorporated the incidence and costs of ADEs and were critically reviewed. One study also explicitly estimated the potential consequences for patient utility. There was a general lack of detail specifically reporting on how ADEs were included in the economic models. Furthermore, there was substantial heterogeneity amongst the nine studies concerning the (i) application of risk-related terminology; (ii) method of incorporating the incidence, costs and consequences of ADEs; and (iii) ADE-related assumptions.

Conclusions

Model-based economic evaluations have played an integral role in healthcare reimbursement and funding decisions relating to anti-TNFs for adult patients with RA. However, current economic models have not routinely or systematically considered the direct costs or consequences of ADEs, which may bias the estimates of the relative cost-effectiveness of anti-TNFs. Omitting information on relevant costs and consequences of interventions for RA will affect the validity of the associated recommendations for informed decision making. To improve current practice it is recommended that (i) greater efforts be made to provide appropriate long-term safety data on the use of anti-TNFs in adult RA; (ii) empirical research be undertaken to identify and quantify the impact of, and possible methods for, including ADEs in economic models to inform future good practice guidelines; and (iii) economic modelling guidelines and reference cases be updated to explicitly identify ADEs as an important treatment outcome and address how they might be incorporated into economic models. Improved consideration of the possible implications of ADEs in economic models will ensure that healthcare decision makers are provided with reliable and accurate information with which to make efficient reimbursement and financing decisions.

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Notes

  1. For the purpose of this review, any adverse event, including serious infections, stated to have occurred whilst actively on drug treatment is viewed as an ADE.

  2. Supporting documents for TA36 were not available.

References

  1. National Institute for Health and Clinical Excellence. Assumptions used in estimating a population benchmark. http://www.nice.org.uk/usingguidance/commissioningguides/raadults/raserviceassumptions.jsp. Accessed 4 June 2012.

  2. 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(1):4–10.

    Article  CAS  PubMed  Google Scholar 

  3. National Rheumatoid Arthritis Society. http://www.nras.org.uk/about_rheumatoid_arthritis/default.aspx. Accessed 10 July 2012.

  4. van der Velde G, Pham B, Machado M, Ieraci L, Witteman W, Bombardier C, et al. Cost-effectiveness of biologic response modifiers compared to disease-modifying antirheumatic drugs for rheumatoid arthritis: a systematic review. Arthritis Care Res. 2011;63(1):65–78.

    Article  Google Scholar 

  5. Schoels M, Wong J, Scott DL, Zink A, Richards P, Landewe R, et al. Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010;69:955–1003.

    Article  Google Scholar 

  6. Benucci M, Gobbi FL, Sabadini L, Saviola G, Baiardi P, Manfredi M. The economic burden of biological therapy in rheumatoid arthritis in clinical practice: cost-effectiveness analysis of sub-cutaneous anti-TNF alpha treatment in Italian patients. Int J Immunopathol Pharmacol. 2009;22(4):1147–52.

    CAS  PubMed  Google Scholar 

  7. National Rheumatoid Arthritis Society. The economic burden of rheumatoid arthritis; 2010. http://www.nras.org.uk/includes/documents/cm_docs/2010/e/1_economic_burden_of_ra_final_30_3_10.pdf.

  8. Symmons DP, Tricker K, Roberts C, Davies L. The British Rheumatoid Outcome Study Group (BROSG) randomised controlled trial to compare the effectiveness and cost-effectiveness of aggressive versus symptomatic therapy in established rheumatoid arthritis. Health Technology Assessment; 2005. Report No.: HTA 34.

  9. McIntosh E. The cost of rheumatoid arthritis. Br J Rheumatol. 1996;35:781–90.

    Article  CAS  PubMed  Google Scholar 

  10. Sfikakis P. The first decade of biologic TNF antagonists in clinical practice: lessons learned, unresolved issues and future directions. Curr Dir Autoimmun. 2010;11:180–210.

    Article  CAS  PubMed  Google Scholar 

  11. Singh JA, Christensen R, Wells GA, Suarez-Almazor ME, Buchbinder R, Lopez-Olivo MA, et al. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2009;7(4):CD007848.

    Google Scholar 

  12. Bongartz T, Sutton A, Sweeting M. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275–85.

    Article  CAS  PubMed  Google Scholar 

  13. Rubbert-Roth A. Assessing the safety of biologic agents in patients with rheumatoid arthritis. Rheumatology. 2012;51(suppl 5):v38–47.

    Article  CAS  PubMed  Google Scholar 

  14. Keyser FD. Choice of biologic therapy for patients with rheumatoid arthritis: the infection perspective. Curr Rheumatol Rev. 2011;7(1):77–87.

    Article  PubMed Central  PubMed  Google Scholar 

  15. van Dartel SA, Fransen J, Kievit W, Dutmer EA, Brus HL, Houtman NM, et al. Predictors for the 5-year risk of serious infections in patients with rheumatoid arthritis treated with anti-tumour necrosis factor therapy: a cohort study in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Rheumatology (Oxford). 2013;52(6):1052–7.

    Article  Google Scholar 

  16. Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordstrom DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  17. Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL, Silman AJ. Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum. 2007;56(9):2896–904.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  18. Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology. 2011;50(1):124–31.

    Article  CAS  PubMed  Google Scholar 

  19. Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol. 2011;38(7):1258–64.

    Article  CAS  PubMed  Google Scholar 

  20. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, Gromnica-Ihle E, Antoni C, Herzer P, Kekow J, Schneider M, Zink A, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum. 2005;52(11):3403–12.

    Google Scholar 

  21. Craig D, McDaid C, Stock C, Duffy S, Fonseca T, Woolacott N. Are adverse effects incorporated in economic models? An initial review of current practice. Health Technol Assess. 2009;13(62):1–71, 97–181.

    Google Scholar 

  22. European Medicines Agency. Clinical safety data management: definitions and standards for expedited reporting. London: European Medicines Agency; 1995.

    Google Scholar 

  23. Doran MF, Crowson CS, Pond GR, O’Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002;46(9):2287–93.

    Article  PubMed  Google Scholar 

  24. Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalisation for pneumonia. Arthritis Rheum. 2006;54(2):628–34.

    Article  CAS  PubMed  Google Scholar 

  25. Kapetanovic MC, Larsson L, Truedsson L, Sturfelt G, Saxne T, Geborek P. Predictors of infusion reactions during infliximab treatment in patients with arthritis. Arthritis Res Ther. 2006;8(4):R131.

    Article  PubMed Central  PubMed  Google Scholar 

  26. Kielhorn A, Porter D, Diamantopoulos A, Lewis G. UK cost-utility analysis of rituximab in patients with rheumatoid arthritis that failed to respond adequately to a biologic disease-modifying antirheumatic drug. Curr Med Res Opin. 2008;24(9):2639–50.

    Article  CAS  PubMed  Google Scholar 

  27. Marra CA, Bansback N, Anis AH, Shojania K. Introduction to economic modeling for clinical rheumatologists: application to biologic agents in rheumatoid arthritis. Clin Rheumatol. 2011;30(Suppl 1):S9–18.

    Article  PubMed  Google Scholar 

  28. Drummond M. Twenty years of using economic evaluations for reimbursement decisions. What have we achieved? The University of York: Centre for Health Economics; 2012. Report No.: CHE Research Paper 75.

  29. Briggs A, Claxton K, Sculpher M. Decision modelling for health economic evaluation. Oxford: Oxford University Press; 2006.

    Google Scholar 

  30. Caro J, Briggs A, Sibert U, Kuntz K. Modeling good research practices—overview: a report of the ISPOR-SMDM modeling good research practices task force-1. Value Health. 2012;15:796–803.

    Article  PubMed  Google Scholar 

  31. National Collaborating Centre for Chronic Conditions. Rheumatoid arthritis: national clinical guidelines for the management and treatment in adults. London: Royal College of Physicians; 2009.

    Google Scholar 

  32. National Institute for Health and Clinical Excellence. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. The National Institute for Health and Clinical Excellence; 2010. Report No.: TA 195.

  33. Drummond M, Sculpher M, Torrance G. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2005.

    Google Scholar 

  34. Centre for Reviews and Dissemination. Identifying studies for inclusion in NHS EED: economic evaluations. http://www.york.ac.uk/inst/crd/intertasc/nhs_eed_strategies.html. Accessed 15 July 2012.

  35. ScHARR Technology Assessment Group. https://www.shef.ac.uk/scharr/sections/heds/collaborations/tag/topics_and_reports. Accessed 2 Aug 2012.

  36. National Institute for Health and Clinical Excellence. Rheumatoid arthritis (after the failure of previous anti-rheumatic drugs)—golimumab; 2011. Report No.: TA 225.

  37. National Institute for Health and Clinical Excellence. Rheumatoid arthritis—abatacept (2nd line) (rapid review of TA234) (TA280); 2013. Report No.: TA 280.

  38. National Institute for Health and Clinical Excellence. Rheumatoid arthritis (refractory)—rituximab; 2007. Report No.: TA 126.

  39. National Institute for Health and Clinical Excellence. Rheumatoid arthritis (refractory)—abatacept; 2008. Report No.: TA 141.

  40. National Institute for Health and Clinical Excellence. Rheumatoid arthritis—certolizumab pegol; 2010. Report No.: TA 186.

  41. National Institute for Health and Clinical Excellence. Rheumatoid arthritis—tocilizumab; 2012. Report No.: TA247.

  42. National Institute for Health and Clinical Excellence. Adalimumab, infliximab and etanercept for the treatment of rheumatoid arthritis. National Institute for Health and Clinical Excellence; 2007. Report No.: NICE TA 130.

  43. National Institute for Health and Clinical Excellence. Rheumatoid arthritis—anakrina (replaced by CG79). National Institute for Health and Clinical Excellence; 2003. Report No.: TA72.

  44. National Institute for Health and Clinical Excellence. Rheumatoid arthritis—etanercept and infliximab. National Institute for Health and Clinical Excellence; 2002. Report No.: TA 36.

  45. Barton P, Jobanputra P, Wilson J, Bryan S, Burls A. The use of modelling to evaluate new drugs for patients with a chronic condition: the case of antibodies against tumour necrosis factor in rheumatoid arthritis. Health Technol Assess. 2004;8(11):iii, 1–91.

    Google Scholar 

  46. Lekander I, Borgstrom F, Svarvar P, Ljung T, Carli C, van Vollenhoven RF. Cost-effectiveness of real-world infliximab use in patients with rheumatoid arthritis in Sweden. Int J Technol Assess Health Care. 2010;26(1):54–61.

    Article  PubMed  Google Scholar 

  47. Spalding JR, Hay J. Cost effectiveness of tumour necrosis factor-alpha inhibitors as first-line agents in rheumatoid arthritis. Pharmacoeconomics. 2006;24(12):1221–32.

    Article  PubMed  Google Scholar 

  48. Chiou C-F, Choi J, Reyes CM. Cost-effectiveness analysis of biological treatments for rheumatoid arthritis. Expert Rev Pharmacoecon Outcomes Res. 2004;4(3):307–15.

    Article  PubMed  Google Scholar 

  49. Choi HK, Seeger JD, Kuntz KM. A cost-effectiveness analysis of treatment options for patients with methotrexate-resistant rheumatoid arthritis. Arthritis Rheum. 2000;43(10):2316–27.

    Article  CAS  PubMed  Google Scholar 

  50. Choi HK, Seeger JD, Kuntz KM. A cost effectiveness analysis of treatment options for methotrexate-naive rheumatoid arthritis. J Rheumatol. 2002;29(6):1156–65.

    PubMed  Google Scholar 

  51. Nguyen CM, Bounthavong M, Mendes MAS, Christopher MLD, Tran JN, Kazerooni R, et al. Cost utility of tumour necrosis factor-alpha inhibitors for rheumatoid arthritis an application of Bayesian methods for evidence synthesis in a Markov model. Pharmacoeconomics. 2012;30(7):575–93.

    Article  PubMed  Google Scholar 

  52. Kobelt G, Lindgren P, Geborek P. Costs and outcomes for patients with rheumatoid arthritis treated with biological drugs in Sweden: a model based on registry data. Scand J Rheumatol. 2009;38(6):409–18.

    Article  CAS  PubMed  Google Scholar 

  53. Davies A, Cifaldi MA, Segurado OG, Weisman MH. Cost-effectiveness of sequential therapy with tumor necrosis factor antagonists in early rheumatoid arthritis. J Rheumatol. 2009;36(1):16–25.

    PubMed  Google Scholar 

  54. Bansback NJ, Brennan A, Ghatnekar O. Cost effectiveness of adalimumab in the treatment of patients with moderate to severe rheumatoid arthritis in Sweden. Ann Rheum Dis. 2005;64(7):995–1002.

    Article  CAS  PubMed  Google Scholar 

  55. Wu B, Wilson A, Wang F, Wang S, Wallace D, Welsman M, et al. Cost effectiveness of different treatment strategies in the treatment of patients with moderate to severe rheumatoid arthritis in China. PLoS One. 2012;7(10):e47373.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  56. Wong JB, Singh G, Kavanaugh A. Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis. Am J Med. 2002;113(5):400–8.

    Article  PubMed  Google Scholar 

  57. Finckh A, Bansback N, Marra CA, Anis AH, Michaud K, Lubin S, et al. Treatment of very early rheumatoid arthritis with symptomatic therapy, disease-modifying antirheumatic drugs, or biologic agents: a cost-effectiveness analysis. Ann Intern Med. 2009;151(9):612–21.

    Article  PubMed  Google Scholar 

  58. Hallinen TA, Soini EJ, Eklund K, Puolakka K. Cost-utility of different treatment strategies after the failure of tumour necrosis factor inhibitor in rheumatoid arthritis in the Finnish setting. Rheumatology. 2010;49(4):767–77.

    Article  PubMed  Google Scholar 

  59. 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. Rheumatology. 2003;42(2):326–35.

    Article  CAS  PubMed  Google Scholar 

  60. Merkesdal S, Kirchhoff T, Wolka D, Ladinek G, Kielhorn A, Rubbert-Roth A. Cost-effectiveness analysis of rituximab treatment in patients in Germany with rheumatoid arthritis after etanercept-failure. Eur J Health Econ. 2010;11(1):95–104.

    Article  PubMed  Google Scholar 

  61. Puolakka K, Blafield H, Kauppi M, Luosujarvi R, Peltomaa R, Leikola-Pelho T, et al. Cost-effectiveness modelling of sequential biologic strategies for the treatment of moderate to severe rheumatoid arthritis in Finland. Open Rheumatol J. 2012;6(1):38–43.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  62. Saraux A, Gossec L, Goupille P, Bregman B, Boccard E, Dupont D, et al. Cost-effectiveness modelling of biological treatment sequences in moderate to severe rheumatoid arthritis in France. Rheumatology. 2010;49(4):733–40.

    Article  PubMed  Google Scholar 

  63. Soini EJ, Hallinen TA, Puolakka K, Vihervaara V, Kauppi MJ. Cost-effectiveness of adalimumab, etanercept, and tocilizumab as first-line treatments for moderate-to-severe rheumatoid arthritis. JME. 2012;15(2):340–51.

    CAS  PubMed  Google Scholar 

  64. Cimmino MA, Leardini G, Salaffi F, Intorcia M, Bellatreccia A, Dupont D, et al. Assessing the cost-effectiveness of biologic agents for the management of moderate-to-severe rheumatoid arthritis in anti-TNF inadequate responders in Italy: a modelling approach. Clin Exp Rheumatol. 2011;29(4):633–41.

    CAS  PubMed  Google Scholar 

  65. Schipper LG, Kievit W, den Broeder AA, van der Laar MA, Adang EM, Fransen J, et al. Treatment strategies aiming at remission in early rheumatoid arthritis patients: starting with methotrexate monotherapy is cost-effective. Rheumatology. 2011;50(7):1320–30.

    Article  PubMed  Google Scholar 

  66. Beresniak A, Ariza-Ariza R, Garcia-Llorente JF, Ramirez-Arellano A, Dupont D. Modelling cost-effectiveness of biologic treatments based on disease activity scores for the management of rheumatoid arthritis in Spain. Int J Inflam. 2011;2011:727634.

    Article  PubMed Central  PubMed  Google Scholar 

  67. Marra CA, Marion SA, Guh DP, Najafzadeh M, Wolfe F, Esdaile JM, et al. Not all “quality-adjusted life years” are equal. J Clin Epidemiol. 2007;60(6):616–24.

    Article  CAS  PubMed  Google Scholar 

  68. Barbieri M, Wong JB, Drummond M. The cost effectiveness of infliximab for severe treatment-resistant rheumatoid arthritis in the UK. Pharmacoeconomics. 2005;23(6):607–18.

    Article  CAS  PubMed  Google Scholar 

  69. Brennan A, Bansback N, Nixon RM, Madan J, Harrison M, Watson K, et al. Modelling the cost effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry. Rheumatology. 2007;46(8):1345–54.

    Article  CAS  PubMed  Google Scholar 

  70. Brennan A, Bansback N, Reynolds A, Conway P. Modelling the cost-effectiveness of etanercept in adults with rheumatoid arthritis in the UK. Rheumatology. 2004;43(1):62–72.

    Article  CAS  PubMed  Google Scholar 

  71. Diamantopoulos A, Benucci M, Capri S, Berger W, Wintfeld N, Giuliani G, et al. Economic evaluation of tocilizumab combination in the treatment of moderate-to-severe rheumatoid arthritis in Italy. JME. 2012;15(3):576–85.

    PubMed  Google Scholar 

  72. Kobelt G, Lindgren P, Singh A, Klareskog L. Cost effectiveness of etanercept (Enbrel) in combination with methotrexate in the treatment of active rheumatoid arthritis based on the TEMPO trial. Ann Rheum Dis. 2005;64(8):1174–9.

    Article  CAS  PubMed  Google Scholar 

  73. Kobelt G, Lekander I, Lang A, Raffeiner B, Botsios C, Geborek P. Cost-effectiveness of etanercept treatment in early active rheumatoid arthritis followed by dose adjustment. Int J Technol Assess Health Care. 2011;27(3):193–200.

    Article  PubMed  Google Scholar 

  74. Lindgren P, Geborek P, Kobelt G. Modeling the cost-effectiveness of treatment of rheumatoid arthritis with rituximab using registry data from Southern Sweden. Int J Technol Assess Health Care. 2009;25(2):181–9.

    Article  PubMed  Google Scholar 

  75. Russell A, Beresniak A, Bessette L, Haraoui B, Rahman P, Thorne C, et al. Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDS and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis. Clin Rheumatol. 2009;28(4):403–12.

    Article  PubMed  Google Scholar 

  76. Tanno M, Nakamura I, Ito K, Tanaka H, Ohta H, Kobayashi M, et al. Modeling and cost-effectiveness analysis of etanercept in adults with rheumatoid arthritis in Japan: a preliminary analysis. Mod Rheumatol. 2006;16(2):77–84.

    PubMed  Google Scholar 

  77. Vera-Llonch M, Massarotti E, Wolfe F, Shadick N, Westhovens R, Sofrygin O, et al. Cost-effectiveness of abatacept in patients with moderately to severely active rheumatoid arthritis and inadequate response to tumor necrosis factor-alpha antagonists. J Rheumatol. 2008;35(9):1745–53.

    CAS  PubMed  Google Scholar 

  78. Vera-Llonch M, Massarotti E, Wolfe F, Shadick N, Westhovens R, Sofrygin O, et al. Cost-effectiveness of abatacept in patients with moderately to severely active rheumatoid arthritis and inadequate response to methotrexate. Rheumatology. 2008;47(4):535–41.

    Article  CAS  PubMed  Google Scholar 

  79. Wailoo AJ, Bansback N, Brennan A, Michaud K, Nixon RM, Wolfe F. Biologic drugs for rheumatoid arthritis in the Medicare program: a cost-effectiveness analysis. Arthritis Rheum. 2008;58(4):939–46.

    Article  PubMed  Google Scholar 

  80. Welsing PMJ, Severens JL, Hartman M, van Riel PLCM, Laan RFJM. Modeling the 5-year cost effectiveness of treatment strategies including tumor necrosis factor-blocking agents and leflunomide for treating rheumatoid arthritis in the Netherlands. Arthritis Rheum. 2004;51(6):964–73.

    Article  PubMed  Google Scholar 

  81. Brennan A, Chick SE, Davies R. A taxonomy of model structures for economic evaluation of health technologies. Health Econ. 2006;15(12):1295–310.

    Article  PubMed  Google Scholar 

  82. Geborek P, Crnkic M, Petersson IF, Saxne T. Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden. Ann Rheum Dis. 2002;61(9):793–8.

    Article  CAS  PubMed  Google Scholar 

  83. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. London: National Institute for Clinical Excellence; 2008.

    Google Scholar 

  84. Gabriel S, Drummond M, Maetzel A, Bers M, Coyle D, Welch V, et al. OMERACT 6 Economics Working Group report: a proposal for a reference case for economic evaluation in rheumatoid arthritis. J Rheumatol. 2003;30(4):886–90.

    PubMed  Google Scholar 

  85. Weinstein M, O’Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR task force on good research practices—modeling studies. Value Health. 2003;6(1):9–17.

    Article  PubMed  Google Scholar 

  86. British Society for Rheumatology Biologics Register (BSRBR). http://www.medicine.manchester.ac.uk/musculoskeletal/research/arc/clinicalepidemiology/pharmacoepidemiology/bsrbr/. Accessed 15 June 2012.

  87. Atzeni F, Sarzi-Puttini P, Botsios C, Carletto A, Cipriani P, Favalli EG, et al. Long-term anti-TNF therapy and the risk of serious infections in a cohort of patients with rheumatoid arthritis: comparison of adalimumab, etanercept and infliximab in the GISEA registry. Autoimmun Rev. 2012;12(2):225–9.

    Article  CAS  PubMed  Google Scholar 

  88. Zink A, Manger B, Kaufmann J, Eisterhues C, Krause A, Listing J, et al. Evaluation of the RABBIT Risk Score for serious infections. Ann Rheum Dis. 2013. [Epub ahead of print].

  89. Kievit W, Fransen J, Adang EMM, den Broeder AA, Bernelot Moens HJ, Visser H, et al. Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology. 2011;50(1):196–203.

    Article  CAS  PubMed  Google Scholar 

  90. Neovius M, Simard JF, Sundström A, Jacobsson L, Geborek P, Saxne T, et al. Generalisability of clinical registers used for drug safety and comparative effectiveness research: coverage of the Swedish Biologics Register. Ann Rheum Dis. 2011;70(3):516–9.

    Article  CAS  PubMed  Google Scholar 

  91. Sullivan W, Payne K. The appropriate elicitation of expert opinion in economic models: making expert data fit for purpose. Pharmacoeconomics. 2011;29(6):455–9.

    Article  PubMed  Google Scholar 

  92. Emery P. Review of health economics modelling in rheumatoid arthritis. Pharmacoeconomics. 2004;22(2 Suppl 1):55–69.

    PubMed  Google Scholar 

  93. Afzali H, Karnon J, Merlin T. Improving the accuracy and comparability of model-based economic evaluations of health technologies for reimbursement decisions: a methodological framework for the development of reference models. Med Decis Making. 2012;33:325–32.

    Article  PubMed  Google Scholar 

  94. Tappenden P. Conceptual modelling for health economic model development. White Rose Research Online; 2012. Report No.: HEDS Discussion Paper No. 12.05.

  95. Tosh J, Brennan A, Wailoo A, Bansback N. The Sheffield rheumatoid arthritis health economic model. Rheumatology. 2011;50(Suppl 4):iv26–31.

    Article  PubMed  Google Scholar 

  96. Thompson AE, Rieder SW, Pope JE. Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2011;63(6):1479–85.

    Article  CAS  PubMed  Google Scholar 

  97. Sonnenberg F, Beck R. Markov models in medical decision making. Med Decis Making. 1993;13:322–39.

    Article  CAS  PubMed  Google Scholar 

  98. Hyrich KL, Silman AJ, Watson KD, Symmons DP. Anti-tumour necrosis factor alpha therapy in rheumatoid arthritis: an update on safety. Ann Rheum Dis. 2004;63(12):1538–43.

    Article  CAS  PubMed  Google Scholar 

  99. Karnon J, Stahl J, Brennan A, Caro J, Mar J, Moller J. Modeling using discrete event simulation: a report of the ISPOR-SMDM modeling good research practices task force-4. Value Health. 2012;15:821–7.

    Article  PubMed  Google Scholar 

  100. Briggs A, Gray A. Handling uncertainty in economic evaluations of healthcare interventions. BMJ. 1999;519:635.

    Article  Google Scholar 

  101. McGauran N, Wieseler B, Kries J, Schüler YB, Kölsch H, Kaiser T. Reporting bias in medical research—a narrative review. Trials 2010;11:37.

    Google Scholar 

  102. Jobanputra P. A clinician’s critique of rheumatoid arthritis health economic models. Rheumatology. 2011;50(Suppl 4):iv48–52.

    Article  PubMed  Google Scholar 

  103. Krumholz H. Registries and selection bias: the need for accountability. Circ Cardiovasc Qual Outcomes. 2009;2:517–8.

    Article  PubMed  Google Scholar 

  104. Cross J, Garrison Jr L. Challenges and Opportunities for improving benefit-risk assessment of pharmaceuticals from an economic perspective. Office of Health Economics; 2008. Report No.: OHE Briefing 43.

  105. Kobelt G, Jonsson L, Lindgren P, Young A, Eberhardt K. Modeling the progression of rheumatoid arthritis: a two-country model to estimate costs and consequences of rheumatoid arthritis. Arthritis Rheum. 2002;46(9):2310–9.

    Article  PubMed  Google Scholar 

  106. Strangfeld A, Eveslage M, Schneider M, Bergerhausen HJ, Klopsch T, Zink A, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis. 2011;70(11):1914–20.

    Google Scholar 

  107. Ding T, Ledingham J, Luqman R, Westlake S, Hyrich K, Lunt M, et al. BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies. Rheumatology. 2010;49(11):2217–9.

    Google Scholar 

  108. Hay J. Evaluation and review of pharmacoeconomic models. Expert Opin Pharmacother. 2004;5(9):1867–80.

    Article  PubMed  Google Scholar 

  109. Petrou S, Gray A. Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting. BMJ. 2011;342:d1766.

    Article  PubMed  Google Scholar 

  110. Drummond MF, Barbieri M, Wong JB. Analytic choices in economic models of treatments for rheumatoid arthritis: what makes a difference? Med Decis Making. 2005;25(5):520–33.

    Article  CAS  PubMed  Google Scholar 

  111. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004;50(5):1400–11.

    Article  CAS  PubMed  Google Scholar 

  112. Boggs R, Sengupta N, Ashraf T. Estimating health utility from a physical function assessment in rheumatoid arthritis (RA) patients treated with adalimumab (HUMIRA) [abstract]. International Society of Pharmacoeconomics and Outcomes Research; 2002. Abstract UT3.

  113. Kobelt G, Eberhardt K, Jonsson L, Jonsson B. Economic consequences of the progression of rheumatoid arthritis in Sweden. Arthritis Rheum. 1999;42(2):347–56.

    Article  CAS  PubMed  Google Scholar 

  114. Bjornadal L, Baecklund E, Yin L, Granath F, Klareskog L, Ekbom A. Decreasing mortality in patients with rheumatoid arthritis: results from a large population based cohort in Sweden, 1964-95. J Rheumatol. 2002;29(5):906–12.

    PubMed  Google Scholar 

  115. Yelin E, Wanke LA. An assessment of the annual and long-term direct costs of rheumatoid arthritis: the impact of poor function and functional decline. Arthritis Rheum. 1999;42(6):1209–18.

    Article  CAS  PubMed  Google Scholar 

  116. Kobelt G, Lindgren P, Lindroth Y, Jacobson L, Eberhardt K. Modelling the effect of function and disease activity on costs and quality of life in rheumatoid arthritis. Rheumatology. 2005;44(9):1169–75.

    Article  CAS  PubMed  Google Scholar 

  117. Ekman M, Zethraeus N, Dahlstrom U, Hoglund C. Cost-effectiveness of bisoprolol in chronic heart failure. Lakartidningen. 2002;99(7):646–50.

    PubMed  Google Scholar 

  118. Chiou CF, Weisman M, Sherbourne CD, Reyes C, Dylan M, Ofman J, et al. Measuring preference weights for American college of rheumatology response criteria for patients with rheumatoid arthritis. J Rheumatol. 2005;32(12):2326–9.

    PubMed  Google Scholar 

  119. Jobanputra P, Barton P, Bryan S, Burls A. The effectiveness of infliximab and etanercept for the treatment of rheumatoid arthritis: a systematic review and economic evaluation. Health Technol Assess. 2002;6(21):1–110.

    CAS  PubMed  Google Scholar 

  120. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26–37.

    Article  CAS  PubMed  Google Scholar 

  121. Michaud K, Messer J, Choi HK, Wolfe F. Direct medical costs and their predictors in patients with rheumatoid arthritis: a three-year study of 7,527 patients. Arthritis Rheum. 2003;48(10):2750–62.

    Article  PubMed  Google Scholar 

  122. Kavanaugh A, Heudebert G, Cush J, Jain R. Cost evaluation of novel therapeutics in rheumatoid arthritis (CENTRA): a decision analysis model. Semin Arthritis Rheum. 1996;25(5):297–307.

    Article  CAS  PubMed  Google Scholar 

  123. Askling J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Feltelius N, et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis. 2007;66(10):1339–44.

    Article  PubMed  Google Scholar 

  124. Jacobsson LT, Lindroth Y, Marsal L, Juran E, Bergstrom U, Kobelt G. Rheumatoid arthritis: what does it cost and what factors are driving those costs? Results of a survey in a community-derived population in Malmo, Sweden. Scand J Rheumatol. 2007;36(3):179–83.

    Article  CAS  PubMed  Google Scholar 

  125. Askling J. Risk for tuberculosis following treatment of rheumatoid arthritis with anti-TNF therapy—the Swedish experience 1998–2008. Ann Rheum Dis. 2009;68(Suppl 3):422.

    Google Scholar 

  126. Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA Statement. BMJ. 2009;339:b2535.

    Article  PubMed Central  PubMed  Google Scholar 

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Acknowledgments

All authors conceived the study. Eleanor Heather carried out the data extraction, summarised the data, and prepared the first draft of the manuscript. All authors contributed to the interpretation of the data and to the final version of the paper. All authors have read and approved the final manuscript and agree to be accountable for all aspects of the study. Professor Katherine Payne is guarantor.

Eleanor Heather was funded by a National Institute for Health Research (NIHR) Research Methods Fellowship. This paper presents independent research funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. Professor Deborah Symmons is the principle investigator for the British Society for Rheumatology Rheumatoid Arthritis Register (BSRBR-RA). The BSRBR-RA is funded by a grant from the British Society for Rheumatology, using funds negotiated by them from the following drug companies: Abbott, Pfizer, Merck, Roche, and USB. Professor Katherine Payne and Dr Mark Harrison declare no competing interests.

The authors would like to thank Mary Ingram for her help in designing the search strategies, Sean Gavan for his help with updating the searches, and Caroline Vass for her assistance in screening the titles and abstracts of all returned studies.

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Authors and Affiliations

  1. Manchester Centre for Health Economics, Institute of Population Health, Jean McFarlane Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK

    Eleanor M. Heather, Katherine Payne & Mark Harrison

  2. Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester, UK

    Deborah P. M. Symmons

  3. NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK

    Deborah P. M. Symmons

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  1. Eleanor M. Heather
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Correspondence to Katherine Payne.

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Heather, E.M., Payne, K., Harrison, M. et al. Including Adverse Drug Events in Economic Evaluations of Anti-Tumour Necrosis Factor-α Drugs for Adult Rheumatoid Arthritis: A Systematic Review of Economic Decision Analytic Models. PharmacoEconomics 32, 109–134 (2014). https://doi.org/10.1007/s40273-013-0120-z

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