OBJECTIVES To determine the cost-effectiveness, from the Brazilian Ministry of Health perspective, of Fluvastatin IR 20 mg, Fluvastatin IR 40 mg, Fluvastatin IR 80 mg and Fluvastatin XL 80. Also we calculated the budget impact of introducing Fluvastatin XL 80 mg into the current Brazilian national drug formulary. METHODS The cost effectiveness was determined using clinical data from published systematic review and cost the costs were valued using government prices. The costs was in Brazilian reais (BRL) and the price year was 2008 (1$US=1.63 BRL). The benefit measure used in this economic evaluation was LDL- reduction. Using the Healtchare System database' data we described the evolution of consumption of statins in Brazilian Health System. Univariate sensitivity analysis tested model robustness. We calculated the budget impact analysis for three years. RESULTS The Fluvastatin XL 80 mg is the statin more cost-effective and permits the cost reduction in BRL $26,10 per patient. The sensitivity analysis of budget impact show that introduction Fluvastatin into formulary could generate average savings of 18% of the Fluvastatin's total budget or BRL 56,500 ($US 34,600). CONCLUSIONS The inclusion of Fluvastatin XL 80 mg is aligned with the health authority strategy of cost containment or reduction for this class of medicines. Results are sensitive to the list price of drugs.