OBJECTIVES: The addition of rituximab to cyclophosphamide, vincristine and prednisolone (R-CVP) significantly improved time-to-progression by 17 months in patients with previously untreated advanced follicular lymphoma (Marcus et al, 2008). Based on these results, we evaluated the clinical outcomes and cost-effectiveness of R-CVP versus CVP alone from the perspective of the Romanian National Health Insurance House and Ministry of Health. METHODS: A Markov model with a 10-year time horizon was developed based on the randomized controlled trial reported by Marcus et al. (2008). Rates of disease progression were derived from the PFS Kaplan-Meier curves, mortality rates were obtained from the Scotland-Newcastle Lymphoma Group database and Romanian age-specific mortality tables. The duration of the treatment effect of rituximab was conservatively applied for the period of clinical trial follow-up (90 months) (hazard ratio = 0.468). Direct costs included: drug acquisition costs (maximum price from Romanian drugs list 2008), hospitalization costs taken from NSPHHSM and NHIH (2008) and calculated based on the tariff per chemotherapy administration episode, and post-treatment surveillance costs. Costs were discounted by 6.0% p.a. RESULTS: This analysis showed that for each FL treatment where R-CVP is used instead of CVP, the average benefit to the patient would be an additional 0.983 life years gained (LYG), and 0.931 years when quality-adjusted (QALY). Drug acquisition costs were higher with rituximab, however, this was partially offset by lower costs for progression. When R-CVP is compared to CVP alone, the incremental cost per LYG or QALY gained was calculated as €7155 and €7557, respectively. Sensitivity analyses indicated these results were sensitive to the time horizon (longer the time horizon, lower the cost per QALY gained) and that the model was robust. CONCLUSIONS: This study confirms the long-term clinical and economic benefits of adding rituximab to CVP in patients with FL in Romania.