OBJECTIVES :To estimate of budget impact of introduction Fluticasone/salmeterol combination to treatment of Chronic Obstructive Pulmonary Disease (COPD) into the Brazilian National Drug Formulary. METHODS :We used the PLATINO Survey to estimate the number patients with moderate, severe and very severe stages of COPD and GOLD recommendations to estimate the medication costs of change in São Paulo Protocol to Treatment of COPD. We used the cost-effectiveness results of the four therapeutic options: usual care (UC), long-acting anticholinergic drug, Tiotropium (TIO); long-acting beta-agonist, Salmeterol (SAL); and Fluticasone/Salmeterol (SERETIDE®). The measure effectiveness was the exacerbations. The perspective adopted was of the Brazilian Public Health Care System (SUS). The budget impact was calculated to four scenarios. A one-way sensitivity analysis was performed. RESULTS :The additional costs incorporation of fluticasone/salmeterol (SERETIDE®) in SUS were between US$70,438 and US$5 millions. The best scenario (2) was 20% patients in usual care and 80% in Fluticasone/salmeterol (SERETIDE®). In sensitivity analysis some parameters (price, effectiveness) were changed and the scenario 2 remains the best. In this scenario occurred in the incremental cost per patient was US$2.21 and incremental cost per reduction exacerbation was US$43.13. If we analysed only medication costs the incorporation is cost saving (US$9 millions. CONCLUSIONS :SERETIDE® offers the protection against exacerbations at low cost compared with TIO. If all costs are computed is needed an incremental budget of US$2.21 per patient. Their incorporation is cost saving and can to extend the pharmacotherapy for to more patients. The results showed the need of guidelines to assure the best resource allocation.