OBJECTIVES: Gemcitabine is a new anticancer drug that has recently been proposed for the treatment of advanced pancreas cancer. The therapy with gemcitabine has been reported to confer a survival advantage in comparison with fluorouracil. Since gemcitabine is expensive, we estimated the cost per life-year gained using gemcitabine for this clinical indication. METHODS: The clinical material utilised in our analysis was derived from a randomised clinical trial in which the survival of patients receiving gemcitabine was compared with that of patients receiving fluorouracil. To obtain an estimate of effectiveness, the survival curves published in the trial were analysed using the Gompertz methodology. Gemcitabine acquisition cost was based on wholesale price in Italy, in the UK and in the U.S. The overall cost of treatment is presently being estimated by collecting individual data on the use of resources and morbidity costs. RESULTS: The analysis of the survival curves showed that the mean survival of patients treated with gemcitabine was 6.29 months, while the corresponding value for patients receiving standard treatment was 3.20 months (both values include discounting at an annual rate of 3%). The survival gain for the gemcitabine group was 2.9 months per patient. Our analysis of cost data for these two treatments is in progress, but preliminary data show that the incremental cost is less than $20,000 per patient. CONCLUSIONS: In pancreatic cancer, gemcitabine determines a survival gain of approximately 3 months. Its cost-effectiveness profile seems to be within acceptable values.