OBJECTIVES : To estimate the budget impact of incorporating Levetiracetam as combined therapy treatment for refractory epilepsy in the Brazilian Public Health System.

METHODS : In order to estimate the number of patients eligible for treatment with Levetiracetam, the total number of patients receiving treatment for refractory epilepsy in the Brazilian Public Health System was observed between the years of 2013 to 2016 through the DATASUS database and a linear regression equation was calculated in order to estimate the number of patients for the following 5 years. Out of the total yearly number of patients, 7% were excluded due to be receiving monotherapy treatment, 12.6% were classified under ICD-10 G40.8 and were also excluded, it was also assumed that 20% of patients would receive treatment in the first year with a gradual increase up to 60% in the fifth year other scenarios were considered in a sensitivity analysis. Treatment costs were calculated considering an average daily dosage of 2000mg per patient, the drug costs were assumed to be R$0,79 per 250mg tablet, as Levetiracetam was to be incorporated as a combined therapy treatment, it was assumed that consumption of other treatments would remain the same.

RESULTS : The estimated number of patients to receive treatment ranged between 12,718 in 2018 and 45.314 in 2022. Average annual treatment costs per patient were calculated as R$2,315,56. Budget impact was estimated to be R$29 million in the first year and R$329 million for the next five years. A sensitivity analysis suggested results may range between R$22 million and R$66 million in the first year and between R$204 and 503 million for the next five years.

CONCLUSIONS : Results show that there is considerable uncertainty regarding the budget impact calculated for the incorporation of Levetiracetam but the data was reliable enough to assist in the decision-making process.