CAPECITABINE (X) VS. BOLUS 5-FU/LV AS ADJUVANT THERAPY FOR PATIENTS (PTS) WITH DUKES' C COLON CANCER: PHARMACOECONOMIC EVALUATION OF X-ACT TRIAL DATA FROM A CZECH PERSPECTIVE

Introduction: As adjuvant treatment for colon cancer, X leads to at least equivalent disease-free survival (DFS) and an improved safety profile vs. bolus 5-FU/LV [Twelves et al. NEJM 2005;352:2696-704]. X also demonstrates superior relapse-free survival (65.5% vs. 61.9% at 3 years follow-up; p=0.04) and improved covariate-adjusted overall survival (p=0.02). We used X-ACT trial data to evaluate the cost-effectiveness of X from a Czech perspective. Methods: We used clinical trial data and published sources in the Czech Republic to determine utilisation and unit costs for drug administration, hospitalisations, physician consultation visits, and concomitant medications. Cost for pt time and travel were also considered (societal perspective). A health-state transition model was used to estimate incremental cost impact and the effectiveness in terms of gains in quality-adjusted life months (QALMs). Costs and effectiveness were discounted at 6% and 1.5%, respectively. Results: Acquisition costs were higher for X (3502€) than 5-FU/LV (302€), but this difference was almost fully offset by significantly higher 5-FU/LV administration costs (difference of 2092€), cost of adverse events and hospitalisation costs (difference of 403€); this resulted in comparable direct costs (difference of 657€ for X vs. 5-FU/LV). Pt travel and time costs were lower for X vs. 5-FU/LV (cost savings 679€). Adding indirect costs to the direct costs showed that X is cost saving, requiring 22€ less per patient than 5-FU/LV. In addition, X is projected to increase QALMs by 9 months compared with 5-FU/LV. Conclusions: The use of a societal perspective to measure the time and travel costs associated with the treatments illustrates the advantage of oral X over bolus 5-FU/LV treatment. X is also projected to increase life expectancy vs. 5-FU/LV. From the point of view of incremental cost-utility analysis, X vs. 5-FU/LV can be considered a dominant (cost-saving and more-effective) therapy. This pharmacoeconomic analysis supports the replacement of 5-FU/LV with X for the adjuvant treatment of colon cancer in the Czech Republic.Supported with a research grant from Roche