Infliximab cost-effectiveness/safety?

B. M. Rothschild

Northeastern Ohio Universities College of Medicine, Youngstown, OH, USA. E-mail: bmr{at}neoucom.edu

SIR, There is no question that tumour necrosis factor inhibitors have made a major difference in our ability to control rheumatoid arthritis. Claims [14] related to cost-effectiveness of one such inhibitor, infliximab (Remicade), must be more closely examined.

It is ‘bothersome’ to find allegations that one can demonstrate lifetime cost-effectiveness based on limitation of use to only 1 or 2 yr of therapy [14] with a medication whose benefits disappear to baseline with its cessation [5, 6]. Kobelt et al.'s [1] recent article must be reconciled with their 2001 American College of Rheumatology meeting presentation [2]. They reported US$6600 extra cost offset the direct costs of methotrexate therapy by $1190, suggesting a cost per ‘quality of life’ gain of $29 900. This study was very difficult to assess, as multiple clinical trials were combined and their listed direct product cost was less than half that in clinical practice in both the UK and the USA. They reported a cost-effectiveness ratio of $38 200 per discounted quality-adjusted life year (QALY). However, this (similar to the present study) was predicated on the use of infliximab for no more than 2 yr! Their more recent study is similarly difficult to interpret, as it uses historical controls of individuals with early rheumatoid arthritis (different catchment group from infliximab group) from a disparate time period (5–15 yr prior). The assumption that treatment approaches were the same for the historical and infliximab groups makes the unwarranted assumption of absence of progress in rheumatological care approaches over that time period.

These analyses [14] appear to represent biased secondary analyses of clinical trials, as opposed to real-world usage experience and do not seem to factor in toxicity issues [710]. Maksymowych et al. [8] reported adverse events in 32.6% (11.6% infectious, 4.2% gastrointestinal, 3.2% haematological) after a mean of only 4.2 infusions in 95 patients. Adverse events were considered severe in 11.6%. Safety is especially of concern in view of the report of cancer in 1 of 17 patients by Shergy et al. [9] and in 1 of 32 patients by Yazici et al. [10] within 1 yr of therapy initiation.

Therapies targeting tumour necrosis factor are clearly effective in treatment of rheumatoid arthritis [5, 6]. Data on relative safety and expense of currently available etanercept (Enbrel) and infliximab (Remicade) would seem to favour etanercept [11] were it not for the insurance reimbursement fluke (at least in the USA): payment in the USA is generally available for infusion of infliximab, while use of etanercept is economically limited to only those patients with full prescription coverage or who have sufficient ‘disposable income’ to afford the $10 000-plus per year expense. I look forward to application of Kobelt et al.'s [1] methodology to calculation of the true cost-effectiveness of medications (including toxicity), use of which is likely to be required for decades.

References

  1. 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;42:326–35.[Abstract/Free Full Text]
  2. Kobelt G, Jonsson L, Lindquist E, Speracedes KE. Cost-effectiveness of infliximab (Remicade) in Sweden. Arthritis Rheum 2001;44:S158.
  3. Wong JB, Singh G, Kavanaugh A. Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis. Am J Med 2002;113:400–8.[CrossRef][ISI][Medline]
  4. Wong JB, Breedveld FC, Smolen JS et al. Cost-effectiveness of 102 weeks of infliximab for rheumatoid arthritis. Arthritis Rheum 2001;44:S311.
  5. St. Clair EW, Wagner CL, Fasanmade AA et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis. Arthritis Rheum 2002;46:1451–9.[CrossRef][ISI][Medline]
  6. Lipsky PE, van der Heijde DM, St. Clair EW et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594–602.[Abstract/Free Full Text]
  7. Daniel CL, Moreland WL. Infliximab: Additional safety data from an open label study. J Rheumatol 2002;29:647–9.[ISI][Medline]
  8. Maksymowych WP, Mallon C, Spady B, Peerani R. The Alberta Capital Health Region infliximab in rheumatoid arthritis prospective observational inception cohort: Efficacy, adverse events and withdrawal. Arthritis Rheum 2001;44:S82.
  9. Shergy WJ, Phillips RM Jr, Hernandez J. Safety and efficacy of infliximab therapy after etanercept failure. Arthritis Rheum 2001;44:S81.
  10. Yazici Y, Erkan D, Kulman I, Schwartzman S, Harrison MJ. Etanercept (ETA) vs infliximab (INF): A comparison of efficacy in controlling rheumatoid arthritis (RA) flares during the first year of therapy and the year prior to their use. Arthritis Rheum 2001;44:S81.
  11. Malone DC. Cost-effectiveness analysis of etanercept monotherapy versus infliximab plus methotrexate in the treatment of rheumatoid arthritis. Arthritis Rheum 2001;44:S322
Accepted 17 April 2003





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