OBJECTIVES: Direct cost comparison of glatiramer acetate (GA) and fingolimod for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in Spain. METHODS: To compare GA and fingolimod a cost analysis model, based on a 1-year time horizon, was developed. In addition to the pharmacological costs, resource use was estimated for GA (1 hour of training with nursing staff in self-injection techniques for subcutaneous administration) and fingolimod (vaccination for varicella-zoster virus in 5% of patients, 3 complete blood counts per year, 3 ophthalmology visits for prevention of macular edema, 3 transaminase tests to monitor liver function, and cardiovascular monitoring consisting of 1 ECG before the first fingolimod dose and at 6 hours; 1 day outpatients-hospital visit for cardiological monitoring during 6 hours on the day of the first fingolimod dose, with follow-up of blood pressure and heart rate every hour). The pharmacological costs were calculated based on the ex-factory price of the drugs evaluated, using the doses recommended in the respective SmPc. Total invoicing volume was discounted by 7.5%, as laid down in Spanish Royal Decree 8/2010. Unitary costs were obtained from the e-Salud database and the drug catalog. Costs in the model are expressed in € 2012. RESULTS: The cost of annual treatment was €9,439.42 for GA and €19,602.18 for fingolimod, yielding a cost difference of €10,162.76. Assuming a fixed budget of €100,000.00, approximately 10 patients could be treated with GA, compared to 5 with fingolimod. CONCLUSIONS: Fingolimod therapy requires twice the investment of GA.