Quality of life and economic impact of refractory epilepsy in Spain: the ESPERA study.

INTRODUCTION: Despite use of currently available anti-epileptic drugs (AED), 30% of epilepsy patients are not seizure-free. The purpose of this study was to estimate the quality of life and economic impact in Spain of drug-resistant epilepsy (DRE), as defined by the International League Against Epilepsy (ILAE). METHODS: Observational retrospective 12-month study conducted in Spain including adults with focal epilepsy treated with at least two AEDs. Direct costs (€ 2010) were calculated based on health care resources used and their official unit costs. Costs were analysed from the perspectives of the Spanish National Health System (SNS) and society. The impact of DRE on patients' quality of life was examined using the QOLIE 31-P, EQ-5D-3L, and NDDIE questionnaires. RESULTS: We analysed 263 patients out of the 304 recruited. According to ILAE criteria, 70.0% of the patients had drug-resistant epilepsy, while 20.3% achieved seizure freedom. From the viewpoint of the SNS, annual costs for resistant and seizure-free patients were € 4964 and € 2978 respectively (P<.01). Compared to resistant patients, seizure-free patients showed better scores on QOLIE-31P (70.8 vs 56.4, P<.0001) and EQ-5D-3L (75.6 vs 64.7, P<.001). Seizure-free patients showed a lower incidence of major depression compared to resistant patients according to the NDDIE scale (23 vs 8.3%, P<.05). CONCLUSIONS: Results suggest that DRE is associated with increased use of healthcare resources and consequently with higher costs, poorer quality of life and higher incidence of major depression compared to seizure-free patients, thus representing a considerable burden to the SNS and society.

Cost-effectiveness analysis of pazopanib in second-line treatment of advanced soft tissue sarcoma in Spain.

PURPOSE: To assess the efficiency of pazopanib compared with trabectedin in the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) after chemotherapy failure. METHODS: The progression of STS was modeled using a partitioned survival analysis model. Survival curves for pazopanib and trabectedin were modeled using data from PALETTE phase III clinical trial and based on unadjusted indirect comparison. Effectiveness was measured in quality-adjusted life years (QALY). The Spanish National Health System perspective was considered over a 10-year time horizon, including direct health care costs (, 2014). A discount rate of 3% was applied to both costs and outcomes. The robustness of the results was evaluated using univariate and probabilistic sensitivity analyses (PSA). RESULTS: Pazopanib was associated with better health outcomes than trabectedin (0.705 versus 0.686 QALY). Pazopanib also showed lower direct health care costs (21,861 versus 45,338), mainly due to lower cost of pharmacological treatment (13,762 versus 33,392), administration (57 versus 2,955) and AE management (658 versus 1,695) costs. PSA confirmed that pazopanib was a dominant option in 71% of the simulations performed. CONCLUSIONS: In this analysis, and from a health economics perspective, pazopanib was the option of choice versus trabectedin in the treatment of adult patients with advanced soft-tissue sarcoma after chemotherapy failure.

Direct cost of management and treatment of active systemic lupus erythematosus and its flares in Spain: the LUCIE Study.

BACKGROUND AND OBJECTIVE: The cost of control and management of Systemic Lupus Erythematosus (SLE) in Spain is unknown. This study has aimed to describe the healthcare resources associated to control and treatment of LES and its flares and to estimate the associated direct costs. PATIENTS AND METHODS: This was a European, multicentric, retrospective study (2008-2010) carried out with the participation of 5 hospitals in Spain with experience in SLE. Adult SLE patients (ACR criteria), with positive auto-antibodies (ANA and/or anti-ds-DNA) and active disease were included. Patients were stratified into severe and non-severe SLE. Direct healthcare costs were estimated with resources used and their unit costs. RESULTS: Seventy-five out of 79 SLE patients were analyzed. Of these, 52% had severe disease, 91.9% were females and 90.7% were Caucasian. Mean (SD) age was 41.0 (14.5) years. Annual direct cost per patient related to SLE management was €5,968 (7,038) and €3,604 (5,159) for severe and non-severe patients, respectively (P=.002). Costs related to hospitalizations, pharmacological treatment, visits to specialists, and laboratory tests were higher for patients with severe disease. At least one flare during the observation period was present in 90.7% of patients. Severe flares were a significant predictor of increase in cost. CONCLUSIONS: The cost associated with SLE control and treatment is higher for severe SLE patients. Insufficient control of the disease activity results in an increase in flares. Its presence is related to an increase in costs, hospitalization being the major component.