Cost-Effectiveness of Levetiracetam for Patients With Juvenile Myoclonic Epilepsy: A Modeling Approach By The Brazilian Public Health Care System Perspective

OBJECTIVES: Sodium valproate is the recommended antiepileptic drug (AED) in the Brazilian public Healthcare System (SUS) for the treatment of juvenile myoclonic epilepsy (JME). However, approximately 30% of patients do not achieve a satisfactory control with valproate, raising the need for add-on AEDs. Levetiracetam is the only AED with labeled indication for JME, but it is not included in the SUS formularies. This study aimed to assess the cost-effectiveness and additionally the budget impact (BI) of levetiracetam for patients with JME in comparison with the SoC. METHODS: A 16-week decision tree was developed with three health states: response; lack of response and death. Efficacy, QoL and transition probabilities assumptions came from a randomized triall. A Markov model was developed for the 10-year period following the decision three. The model accounted for discontinuation rates, QoL and costs. A probabilistic sensitivity analysis was conducted to evaluate the robustness of the results. For the BI, drug acquisition costs, dosage regimen and population growth were considered. In addition, a one-way sensitivity analyses were performed. RESULTS: The total number of patients with JME calculated was 44,616. From these, we assumed that 4,698 (10%) would be taking levetiracetam in the fifth year. The inclusion of levetiracetam would cost an additional BRL 43.6 million, between years 1 and 5, reaching BRL 16.3 million in the fifth year. The calculated ICER was BRL 5,882 /year / response. The ICUR calculated was BRL 58,294 /QALY. The probabilistic sensitivity analysis confirmed the results, demonstrating that levetiracetam was cost-effective in 90% of simulations. CONCLUSIONS: Levetiracetam is a cost-effective treatment option as add-on AED for the treatment of JME, from the perspective of Brazilian Public Health System. Reference: 1-Noachtar S, et al. Neurology 2008; 70: 607-16.