Cost-effectiveness analysis of breast cancer adjuvant treatment : FEC 50 versus FEC 100 (FASG05 study)

Background: The aim of the study was to assess the incremental cost-effectiveness ratio (ICER) of the FEC 100 compared with the FEC 50 in the FASG05 trial. Materials and methods: A cost-effectiveness analysis was performed using a multi-state Markov process model. Relevant clinical data introduced into the model were obtained from 10-year follow-up of the clinical trial FASG05. Survival curves for each health state were assessed by survival parametric model. The model allowed assessments from the start of adjuvant chemotherapy until death. The costs of adjuvant treatment and follow-up were estimated. The costs of recurrence were evaluated from the medical records of 146 patients. A prospective survey was performed on a cohort of 87 patients to quantify the resources external to the hospital (including cost of transportation). The inpatient costs were evaluated using the French diagnosis-related groups. The ambulatory costs were assessed using the French nomenclature. Costs were expressed in 2002 Euro (C), according to the French societal perspective. The ICER assessed the cost of one additional life year saved. A discount rate of 5% per year was used for cost, and alternatively 0%, 3% and 5% for effectiveness. We validated the results with a probabilistic sensitivity analysis incorporating parametric and non-parametric bootstraps, and with the acceptability curves. Results: The mean total discounting cost of adjuvant treatments was It 465 Euro for FEC 50 and 13815 Euro for FEC 100; the mean total discounting cost of recurrences was 14636 Euro and 13503 Euro, respectively. According to the discount rate of effectiveness, the life expectancy was 16.5, 11.4 and 9.3 years for FEC 50 and 18.4, 12.5 and 10.2 years for FEC 100. The ICER (cost per life year saved) were 642 Euro, 1084 Euro and 1460 Euro, respectively. The probability according to which FEC 50 is strictly dominated by FEC 100 was 0.15. Conclusion: The clinical benefit of FEC 100 generates a negligible cost increase when compared with FEC 50.