OBJECTIVES: Cost-utility evaluation comparing Dana-Farber Cancer Institute (DFCI) and Berlin-Frankfurt-Munster (BFM) treatment strategies for childhood ALL. METHODS: Children treated at 7 centres in Canada, Italy and the USA were eligible for health-related quality of life (HRQL) assessment using the Health Utilities Index Mark 3. Parents completed assessments during 4 active treatment phases and at 2-years following therapy. Mean HRQL scores were used to calculate quality-adjusted life years (QALYs). Costs were calculated from the perspective of the Ontario (Canada) health care system. Patients from 2 Ontario centres were eligible for costing. Service utilization was obtained from Canadian Institute of Health Information Discharge Abstract Database and National Ambulatory Care Reporting System records. Standard costs were used for inpatient, outpatient and physician services. Difference in mean cost was assessed by t-test. The analytical horizon was 5 years after diagnosis. Future costs and QALYs were discounted at 5% per year. Sensitivity analyses used 95% confidence bounds (CB) of mean HRQL scores and discount rates of 0% or 3%. RESULTS: A total of 1281 HRQL assessments were collected. Costs were measured for 28 DFCI and 66 BFM patients.  Based on mean HRQL scores, BFM had 0.17 (0.16 at 3% and 0.03 at 0%) more QALYs than DFCI. On lower CB for BFM and upper CB of DFCI mean HRQL scores, BFM had 0.16 (0.16 at 3% and 0.03 at 0%) fewer QALYs than DFCI. Mean costs for BFM ($101484) and DFCI ($98760) did not differ significantly (p=0.777). CONCLUSIONS: The cost-utility evaluation simplified to a QALY-effectiveness analysis because of no significant difference in mean costs.  Sensitivity analysis indicates that mean QALY estimates are imprecise and overlap between the two strategies.  Therefore, BFM and DFCI are equally QALY-effective within the range of estimation uncertainty. Future work will focus on diagnostic sub-groups with more precise cost and QALY estimates.