[Analysis of the cost-effectiveness of treatment for refractory partial epilepsy: a simulation model for pregabalin and levetiracetam]

To estimate the cost-effectiveness (C-E) of pregabalin (PGB) or levetiracetam (LEV) relative to standard therapy (ST) as add-on anti-epileptic therapy in patients with partial refractory epilepsy in Spain.

Using stochastic simulation techniques, we estimated the C-E of PGB (300 mg/day) and LEV (2,000 mg/day) in a hypothetical cohort of 1,000 patients (vs ST). The model used data of efficacy and safety from two randomized controlled clinical trials. Direct medical costs (caused by handling of the disease and the adverse events were estimated using year-2007 prices. Model outcomes included number of additional seizure-free days (over one year), adverse events and quality adjusted life-years (QALYs). We calculated the incremental cost-effectiveness ratio (ICER) per additional seizure-free day and QALY gained.

Compared with ST, treatment with PGB yielded an estimated 43.3 +/- 4.8 (mean +/- standard error) additional seizure-free days, and a gain of 0.04 +/- 0.0006 QALYs over one year. Comparable results for LEV vs ST were 24.3 +/- 6.2 and 0.025 +/- 0.007 QALYs, respectively. The annual total cost (in euros) per patient was 1,843 with PGB, 3,018 with LEV and 897 with ST. Mean ICER for PGB vs ST were 22 euros (95% CI = 19-27) per additional seizure-free day, and 23,881 euros (95% CI = 19,206-30,247) per QALY gained; estimates for LEV were 95 euros (CI 95% = 60-177) and 95,904 euros (CI 95% = 57,137-203,169) respectively.

In patients with partial refractory epilepsy, when compared with ST, PGB demonstrated better ICER per additional seizure-free day and QALY gained than LEV.