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Originally published as JCO Early Release 10.1200/JCO.2008.19.8101 on November 10 2008 © 2008 American Society of Clinical Oncology.
Cost Effectiveness of Sunitinib
Servizio Farmaceutico e Laboratorio di Farmacoeconomia, Azienda Ospedaliera Universitaria di Careggi, Firenze, Italy To the Editor: In comparing an innovative treatment versus a reference treatment, the cost per life year gained makes sense when both of the two following criteria are met: (1) survival is prolonged, and (2) its prolongation is statistically significant. This issue has long been debated in the literature,1 and also on the pages of Journal of Clinical Oncology.2 The authors of the original trial comparing sunitinib versus interferon in metastatic renal cell carcinoma stated that "although there was a trend toward improved survival with sunitinib [...] the comparison did not meet the prespecified level of significance for this interim analysis."3 Likewise, Remák et al4 conducted their cost-effectiveness based on the assumption of noninferiority of sunitinib "based on expert clinical opinion, long-term overall survival with sunitinib could be equal to, but not worse than, that with interferon at any point," and therefore negated, at least in the beginning of their analysis, the hypothesis that sunitinib offers an advantage in overall survival. It is thus surprising to see that Remák et al4 have not accepted the conclusion of Motzer et al3 (no demonstrated survival advantage for sunitinib) nor have they accepted the opinion of their own panel of experts (noninferiority of sunitinib), but have superficially gone to the conclusion that sunitinib determines a survival advantage (gain = 0.11 years per patient v interferon) and that the cost per life year gained can therefore be calculated. Since this superficial methodological choice was in favor of sunitinib, one cannot help noticing that this study was not an independent one,5,6 but was sponsored by the manufacturer of sunitinib. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. NOTES published online ahead of print at www.jco.org on November 10, 2008. REFERENCES
1. Trippoli S, Messori A: Cost-effectiveness analyses of statistically ineffective treatments. JAMA 280:1992-1993, 1998 2. Trippoli S, Vaiani M, Messori A, et al: Survival gain in cost-effectiveness studies. J Clin Oncol 18:3318, 2000 3. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alpha in metastatic renal-cell carcinoma. N Engl J Med 356:115-124, 2007 4. Remák R, Charbonneau C, Négrier S, et al: Economic evaluation of sunitinib malate for the first-line treatment of metastatic renal cell carcinoma. J Clin Oncol 26:3995-4000, 2008 5. Bell CM, Urbach DR, Ray JG, et al: Bias in published cost-effectiveness studies: Systematic review. BMJ 332:699-703, 2006 6. Dobson R: Industry-sponsored studies twice as likely to have positive conclusions about costs. BMJ 327:1006, 2003
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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