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Journal of Clinical Oncology, Vol 23, No 15 (May 20), 2005: pp. 3633-3634 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.05.385
In Reply:Departments of Surgery, Clinical Epidemiology and Biostatistics, and Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton, Ontario, Canada van den Brink1 et al recently reported the results of a cost-utility analysis, which was integrated into the Dutch Total Mesorectal Excision (TME) Trial.2 In an accompanying editorial, we raised issues that should be considered before accepting the analysis conclusion that preoperative radiotherapy (PRT) with TME for rectal cancer is cost effective.3 Here we respond to comments from van den Brink regarding the concerns raised in our commentary.4 The evidence to date from the Dutch TME Trial shows no survival advantage for PRT.2 Therefore, we suggest it is reasonable to use no difference in survival as the base case analysis rather than one of the options in the sensitivity analysis. In the sensitivity analysis section of their paper, when the authors do raise mortality rates after PRT so that life expectancy for the PRT and no-PRT arms are the same (but not worse for PRT) the cost-effectiveness ratio of PRT is $135,700 per QALY (quality-adjusted life year)—a substantially higher figure for a cost-effectiveness ratio than the ephemeral accepted standard that the authors use as a benchmark in their study. A useful sensitivity analysis would then be to adjust the mortality rates of the noninitial states related to local recurrence, so that the 95% CI for the mortality rate differences between patients receiving and not receiving PRT correspond to those actually observed in the Dutch TME Trial. Of interest, recent results from this latter trial show median survivals following local recurrence in the PRT and no-PRT arms of 6.1 months and 15.9 months, respectively. These marked differences by trial arm in the transition rates to death following local recurrence were likely not known at the time of the original cost-utility analysis, and were not considered in the author’s Markov models.5 van den Brink et al agree that the effectiveness and cost-effectiveness of PRT for patients with rectal cancer hinges on expected local recurrence rates—a likely proxy for the quality of rectal surgery. Investigators have reported previously in a subsample of patients from the Dutch TME Trial that only 57% of specimens were of high surgical quality, suggesting that optimal TME surgery was not consistently delivered in the Dutch trial.6 The authors do not adequately address our concerns on the international comparability (or transferability) of economic analyses and the limited usefulness of cost-effectiveness ratios. International comparability of costs (and effects) is a complex issue.7-9 Purchasing power parity (PPP) is presented by van den Brink et al as an alternative method to exchange rates to convert observed Dutch costs to American dollars. But the observation that the PPP value of 1.05 converts hospital costs per day in Holland to $451 US further demonstrates that exchange rates (and even PPP) are of limited value when attempting to use costs from one country for an economic analysis to inform decision makers in another country. More importantly, the authors again prematurely claim that radiotherapy for the great majority of patients undergoing surgery for rectal cancer "provides value for the money" since the cost-effectiveness ratio is $25,100 US per QALY. Cost-effectiveness analyses have been presented in the literature as a methodology to help decision makers allocate limited pools of resources. The underlying premise is that for a given level of resources, the decision maker wishes to maximize the total aggregate health benefits conferred on society.10,11 Furthermore, in the presence of scarcity, the only way to determine if a new intervention represents an efficient use of resources is if "the value of what is gained from an activity outweighs the value of what has to be killed."12 It then follows that from an economic perspective, to determine whether a new medical treatment is worth pursuing one must know (1) the total additional costs and effects to the system that will result from implementing the new more costly but more effective treatment, and (2) an intervention (medical or nonmedical) that, if canceled, will generate the resources necessary to implement the new treatment, and whose cancellation will reduce community well-being by less than the incremental gain expected from the new treatment.13-15 Until both conditions are met researchers should not infer cost effectiveness or "value for the money" for particular therapies—a result prematurely suggested by van den Brink et al in their economic evaluation of PRT and rectal cancer. In their recent response, the authors also state that "data on cost effectiveness are then one of many pieces of information...that might be weighed". In other words, cost-effectiveness analysis is about efficiency only and does not involve equity considerations. However, assuming that efficiency and equity considerations are separable is wrong.16-19 For example, in the analysis presented by the authors they assumed that a QALY is a QALY regardless of who gains it or who loses it. This is an equity assumption. If this equity assumption does not reflect the one held by a decision maker, then the results of the analysis are of no use to the particular decision maker. We do not negate the numerous useful insights presented by van den Brink et al in their paper, or the importance of PRT in the treatment paradigm for some patients undergoing rectal cancer surgery. But in the era of TME it is not yet decided which patients should receive radiotherapy, an observation driven home by the original results of the Dutch TME Trial. Moreover, we encourage researchers performing cost-effectiveness analyses to either consider the opportunity costs of implementing the interventions analyzed, or to avoid concluding that such interventions are cost effective. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest. REFERENCES
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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