Research Article: A Comparison of Cost Effectiveness Using Data from Randomized Trials or Actual Clinical Practice: Selective Cox-2 Inhibitors as an Example

Date Published: December 8, 2009

Publisher: Public Library of Science

Author(s): Tjeerd-Pieter van Staa, Hubert G. Leufkens, Bill Zhang, Liam Smeeth, Peter Jüni

Abstract: Tjeerd-Pieter van Staa and colleagues estimate the likely cost effectiveness of selective Cox-2 inhibitors prescribed during routine clinical practice, as compared to the cost effectiveness predicted from randomized controlled trial data.

Partial Text: Many countries require health technology assessments when deciding on adopting new healthcare technologies. Recently, the American College of Physicians recommended the establishment of an organization for the generation and review of cost-effectiveness analyses [1]. In England and Wales, formal cost-effectiveness analyses are now required and several years ago the National Institute for Health and Clinical Excellence (NICE) was established to balance the financial costs and clinical benefits of health technologies and evaluate their cost effectiveness [2],[3]. It would be of interest to evaluate the experience in England and Wales and evaluate whether previous cost-effectiveness analyses adequately informed and guided medical practice.

Table 1 shows the rate of upper GI events in the large RCTs of coxibs. Study patients were restricted to those who required long-term NSAID exposure and the indication for treatment was mostly OA or RA. Both the CLASS and VIGOR studies did not apply “intention to treat” statistical analyses, but restricted the analyses to events that occurred during treatment or within 14 d of discontinuation of treatment.

Health technology assessments frequently use data from randomized trials for estimates of absolute risks of events and patterns of drug use. Using coxibs as an example, we have shown that cost-effectiveness analyses produced markedly different results depending on the source of the data used in the modeling. The cost effectiveness of coxibs was far worse when the analyses were based on data from actual clinical practice rather than RCTs. The use of data from actual clinical practice rather than RCTs would have radically altered the conclusions of health technology appraisals of coxibs.



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