Rheumatology Advance Access originally published online on August 18, 2008
Rheumatology 2008 47(10):1589-1590; doi:10.1093/rheumatology/ken344
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Comment on: Infliximab, etanercept and adalimumab for the treatment of ankylosing spondylitis: cost-effectiveness evidence and NICE guidance
European Health Economics, Mulhouse, France
Correspondence to: G. Kobelt, European Health Economics, 40 rue Jean Monnet, F - 68200 Mulhouse, France. E-mail: gisela.kobelt{at}he-europe.com
SIR, The recent editorial by Wailoo et al. [1] on cost-effectiveness evidence of TNF-inhibitors in AS is incorrect and worrying in several respects.
First, the critique of the paper by Kobelt et al. [2] is factually wrong. The numbers cited by Wailoo and colleagues are nowhere to be found in this publication, and the ‘mistake’ is thus a construction. The point they make about the flawed review process, and the implicit critique of the reviewers and editors of International Journal of Technology Assessment in Health Care is not substantiated. Instead, there is reason to ask how this editorial cleared this journal's review process.
Second, the authors seem to mix up information that they have gathered through participation in the NICE review process from a manufacturer submission, and what is actually published as a scientific paper. We have no arguments with the procedure that NICE uses qualified reviewers to scrutinize the models and data supplied by the sponsors of the technologies assessed. But the privileged access to information these researchers have should not be used to unfairly criticize and discredit other researchers. It happens now very often that the researchers involved in the NICE process publish their finding as separate scientific papers. This contributes to confusions about what is a NICE application and review, and what is a scientific paper. There are good reasons to keep these two separated, particularly since reviewers can see all models submitted to NICE, but outside researchers have no access to the details of NICE models. This is even more important when the NICE evaluation process has not been completed.
In this case, the manufacturer of infliximab submitted an economic model to NICE and the Assessment Group (AG), along with the necessary raw data (in confidence) to replicate the model. Within this process, the AG found a programming error. The submission stated that patients withdrawing from treatment return to baseline and then progress according to natural history, but the progression was inaccurately programmed in this particular arm of the model. The mistake was corrected and a new version submitted. The authors of the editorial entered this process at a later stage as members of the Decision Support Unit (DSU) commissioned to evaluate the assessment process, and thus use confidential information in an inadequate way.
Third, the editorial rises issues relating to what could be considered conflict of interest and the motivations for the editorial. We understand that the unit at Sheffield University, where two of the authors are affiliated, undertakes consultancy studies for the companies competing in this area. Also, the editorial's recommendation to use the OMERACT guidelines [3], a project that to our knowledge is financed by the pharmaceutical industry, has to be considered bearing in mind that the first author of these guidelines is also one of the authors of the editorial. Finally, the suggestion that the study by Kobelt et al. [2] would not stand the scrutiny according to these guidelines, when it actually does, including in those points specifically relating to AS progression, is surprising.
This controversy illustrates well two sides of the NICE process. On the positive, capable modellers are commissioned to verify submissions, and mistakes can be corrected. On the more worrying side it appears that it is difficult to separate involvement in the evaluation process from personal scientific ambition and commercially supported work. It is surprising that both NICE and the University of Sheffield accept that the same research unit combines commercial consultancy and ‘independent assessments’.
Disclosure statement: G.K. has performed projects in the field of rheumatology as a consultant for Schering-Plough, Wyeth, Amgen, Abbott, Roche and Aventis.
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- Wailoo A, Bansback N, Chilcott J. Infliximab, etanercept and adalimumab for the treatment of ankylosing spondylitis: cost-effectiveness evidence and NICE guidance. Rheumatology (2008) 47:119–20.
[Free Full Text] - Kobelt G, Sobocki P, Sieper J, Braun J. A comparison of the cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in UK based on two different clinical trials. Int J Technol Assess Health Care (2007) 23:368–75.[CrossRef][Web of Science][Medline]
- Bansback N, Maetzel A, Drummond M, et al. Considerations and preliminary proposals for defining a reference case for economic evaluations in ankylosing spondylitis. J Rheumatol (2007) 34:1178–83.
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  Editor Comment on: Infliximab, etanercept and adalimumab for the treatment of ankylosing spondylitis: cost-effectiveness evidence and NICE guidance: Editor's note Rheumatology, October 1, 2008; 47(10): 1590 - 1591. [Full Text] [PDF]
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A. Wailoo, N. Bansback, and J. Chilcott Comment on: Infliximab, etanercept and adalimumab for the treatment of ankylosing spondylitis: cost-effectiveness evidence and NICE guidance: reply Rheumatology, October 1, 2008; 47(10): 1590 - 1590. [Full Text] [PDF]
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