Economic evaluation of oral valdecoxib versus diclofenac in the treatment of patients with rheumatoid arthritis in a randomized clinical trial.

In contrast to economic models that provide probabilistic estimates of economic impact, data extracted from clinical trials may be used to evaluate and compare actual resource utilization and costs. Health-care resource utilization and the costs of these resources were compared from the perspective of the UK National Health Service using data obtained in a 6-month clinical trial of oral valdecoxib 20 mg once daily and diclofenac 75 mg twice daily for the symptomatic treatment of rheumatoid arthritis. However, calculated health-care costs were exclusive of drug acquisition costs because the price of valdecoxib was not available at the time of analysis. While the efficacy of the two treatments was similar, use of valdecoxib was associated with a reduction in total health-care costs amounting to approximately 200 British pounds per patient. This lower cost was associated with reduced use of health-care resources for gastrointestinal serious adverse events (gastrointestinal SAEs). In particular, the incidence of hospitalization and number of hospital days for gastrointestinal SAEs was lower in the valdecoxib group. Analysis of cost per gastrointestinal SAE favoured valdecoxib (cost savings of 742 British pounds), suggesting that even when these events did occur they were less severe. When costs of gastrointestinal SAEs were averaged over the entire population, valdecoxib was suggested to have lower total costs per patient compared with diclofenac (cost savings of 115 British pounds per patient), mainly resulting from significant savings in hospitalization costs (76.49 British pounds per patient). These data are consistent with economic models and suggest that the favourable gastrointestinal profile of valdecoxib observed in clinical trials will be of economic benefit.