References
- WHO. Epilepsy. [Internet]. 2019 [cited 2022 Mar 21]. Available from: https://www.who.int/en/news-room/fact-sheets/detail/epilepsy
- Beghi E. The epidemiology of epilepsy. Neuroepidemiology. [Internet]. 2020 [cited 2022 Mar 21];54(2):185–191. Available from: https://www.karger.com/Article/FullText/503831
- Serrano-Castro PJ, Mauri-Llerda JA, Hernández-Ramos FJ, et al. Adult prevalence of epilepsy in Spain: EPIBERIA, a population-based study. ScientificWorldJournal [Internet]. 2015 [cited 2022 Mar 21];2015:602710. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26783554.
- García-Ramos R, Pastor AG, Masjuan J, et al. FEEN: informe sociosantario FEEN sobre la epilepsia en España. [Internet]. Neurologia. 2011 [cited 2022 Mar 21]. 548–555. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21757265
- Goldenberg MM. Overview of drugs used for epilepsy and seizures: etiology, diagnosis, and treatment. P T. [Internet]. 2010 [cited 2022 Mar 21];35:392–415. Available from: http://professionals.epilepsy.com/page/
- Chen Z, Brodie MJ, Liew D, et al., Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs a 30-year longitudinal cohort study. JAMA Neurol. 2018;75(3):279–286.
- Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc task force of the ILAE commission on therapeutic strategies. Epilepsia. 2010;51(6):1069–1077.
- Villanueva V, Carreño M, Gil-Nagel A, et al. Identifying key unmet needs and value drivers in the treatment of focal-onset seizures (FOS) in patients with drug-resistant epilepsy (DRE) in Spain through multi-criteria decision analysis (MCDA). Epilepsy Behav. [Internet]. 2021 [cited 2022 Mar 21];122:108222. Available from: https://pubmed.ncbi.nlm.nih.gov/34371462/.
- Villanueva V, Girón JM, Martín J, et al. Impacto económico y en calidad de vida de la epilepsia resistente en España: estudio ESPERA. Neurologia. [Internet]. 2013 [cited 2022 Mar 21];28(4):195–204. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22743210
- Sancho J, Peña P, Rufo M, et al. Health and non-health care resources use in the management of adult outpatients with drug-resistant epilepsy in Spain: a cost-of-illness study (LINCE study). Epilepsy Res. [Internet]. 2008 [cited 2022 Mar 21];81(2–3):176–187. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18617369
- Perucca E, Brodie MJ, Kwan P, et al. 30 years of second-generation antiseizure medications: impact and future perspectives [Internet]. Lancet Neurol. Lancet Publishing Group; 2020 [cited 2022 Mar 21]. 544–556. Available from: https://pubmed.ncbi.nlm.nih.gov/32109411/
- Sociedad Española de Neurología. Manual de Práctica Clínica en Epilepsia. Recomendaciones diagnóstico-terapéuticas [Internet]. 2019 [cited 2022 Mar 21]. Available from: http://epilepsia.sen.es/wp-content/uploads/2020/06/Recomendaciones-Epilepsia-SEN-2019.pdf
- CIMA Centro de información de medicamentos [Internet]. [cited 2022 Mar 21]. Available from: https://cima.aemps.es/cima/publico/home.html
- EMA (The European Medicines Agency). Summary of product Characteristics Ontozry (Cenobamate). 2021
- Chung SS, French JA, Kowalski J, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. [Internet]. 2020 [cited 2022 Mar 21];94(22):e2311–22. Available from: https://pubmed.ncbi.nlm.nih.gov/32409485/
- Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(1):38–48.
- Steinhoff BJ. Cenobamate-a new perspective for epilepsy treatment. Nervenarzt. [Internet]. 2021 [cited 2022 Mar 21];92(2):150–160. Available from: https://pubmed.ncbi.nlm.nih.gov/32990790/
- Sociedad Española de Neurología. Guía de Epilepsia [Internet]. 2022 [cited 2022 Jul 05]. Available from: http://guiaepilepsia.sen.es/index.php/guia
- Simoens S. Pharmacoeconomics of anti-epileptic drugs as adjunctive therapy for refractory epilepsy. Expert Rev Pharmacoecon Outcomes Res. [Internet]. 2010 [cited 2022 Mar 21];10(3):309–315. Available from: https://pubmed.ncbi.nlm.nih.gov/20545595/
- EMA (The European Medicines Agency). Summary of product characteristics Briviact (brivaracetam). 2016
- EMA (The European Medicines Agency). Summary of product characteristics Fycompa (perampanel). 2012
- EMA (The European Medicines Agency). Summary of product Characteristics Zebinix (eslicarbazepine acetate). 2009
- EMA (The European Medicines Agency). Summary of product characteristics Vimpat (lacosamide). 2009
- GENESIS-SEFH. Guía de evaluación económica e impacto presupuestario en los informes de evaluación de medicamentos [Internet]. 2016 [cited 2022 Mar 21. Available from: https://gruposdetrabajo.sefh.es/genesis/genesis/Documents/GUIA_EE_IP_GENESIS-SEFH_19_01_2017.pdf
- Clinical expert opinion
- Klein P, Krauss G, and Aboumatar S, et al. Long-term efficacy and safety of adjunctive cenobamate in patients with uncontrolled focal seizures: open-label Extension of a Randomized Clinical Study. Neurology. 2020;94(1008).
- Sperling MR, Klein P, Aboumatar S, et al. Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study. Epilepsia. [Internet]. 2020 [cited 2022 Mar 21];61(6):1099–1108. Available from: https://pubmed.ncbi.nlm.nih.gov/32396252/
- EMA (The European Medicines Agency). Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. 2018. Available from: https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-epileptic-disorders.
- Single technology appraisal | cenobamate for focal onset seizures in epilepsy | committee papers | NICE [Internet]. 2021 [cited 2022 Mar 21]. Available from: https://www.nice.org.uk/guidance/ta753/evidence/appraisal-consultation-committee-papers-pdf-10894234285
- Privitera M, Richy FF, Schabert VF. Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focal seizures. Epilepsy Behav. 2022;126:108429.
- Gonzalez R. Efectividad a largo plazo de cenobamato en epilepsia focal refractaria. Presented at: LXXII Reunión Anual de la Soceidad Española de Neurología. 2020 26 Noviembre-3 Diciembre; Sevilla, España .
- Krauss GL, Perucca E, Kwan P, et al. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: study 307. Epilepsia. [Internet]. 2018 [cited 2022 Mar 21];59(4):866–876.
- Hufnagel A, Ben-Menachem E, Gabbai AA, et al. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013;103(2–3):262–269.
- Rosenfeld W, Fountain NB, Kaubrys G, et al. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav [Internet]. 2014 [cited 2022 Mar 21];41:164–170. Available from: https://pubmed.ncbi.nlm.nih.gov/25461210/
- Toledo M, Whitesides J, Schiemann J, et al. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. Internet]. 2016 [cited 2022 Mar 21];57(7):1139–1151. Available from: https://pubmed.ncbi.nlm.nih.gov/27265725/
- Trinka E, Bauer G, Oberaigner W, et al. Cause-specific mortality among patients with epilepsy: results from a 30-year cohort study. Epilepsia. [Internet]. 2013 [cited 2022 Mar 21];54(3):495–501. Available from: https://pubmed.ncbi.nlm.nih.gov/23167828/
- Oblikue. eSalud - Información económica del sector sanitario [Internet] Available from: http://esalud.oblikue.com/index.asp
- Botplusweb.portalfarma.com. BOT Plus 2. base de datos de medicamentos [Internet]. [cited 2022 Mar 21]. Available from: https://botplusweb.portalfarma.com/botplus.aspx
- Barrachina-Martinez I, Vivas-Consuelo D, Reyes-Santias F Cost-utility model of brivaracetam in the adjunctive treatment of patients with epilepsy in Spain. Expert Rev Pharmacoeconomics Outcomes Res [Internet]. 2020 [cited 2022 Mar 21]. Available from: https://pubmed.ncbi.nlm.nih.gov/33074031/
- de Kinderen RJA, Wijnen BFM, van Breukelen G, et al. From clinically relevant outcome measures to quality of life in epilepsy: a time trade-off study. Epilepsy Res. 2016;125:24–31.
- REvalMed S. Plan para la consolidación de los informes de posicionamiento terapéutico de los medicamentos en el Sistema Nacional de Salud. 2020.
- York Health Economics Consortium. Economically Justifiable Price [Internet]. 2016 [cited 2022 Mar 21]. Available from: https://yhec.co.uk/glossary/economically-justifiable-price/
- Vallejo-Torres L, García-Lorenzo B, Serrano-Aguilar P. Estimating a cost-effectiveness threshold for the Spanish NHS. Health Econ. [Internet]. 2018 [cited 2022 Mar 21];27(4):746–761. Available from: https://pubmed.ncbi.nlm.nih.gov/29282798
- Sacristán JA, Oliva J, Campillo-Artero C, et al. What is an efficient health intervention in Spain in 2020?. Gac Sanit. 2020;34(2):189–193.
- Whitney R, Donner EJ Risk factors for sudden unexpected death in epilepsy (SUDEP) and their mitigation [Internet]. Curr. Treat. Options Neurol. Current Science Inc.; 2019 [cited 2022 Mar 21]. Available from: https://pubmed.ncbi.nlm.nih.gov/30758730/
- Harden C, Tomson T, Gloss D, et al. Practice guideline summary: sudden unexpected death in epilepsy incidence rates and risk factors: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. [Internet]. 2017 [cited 2022 Mar 21];88(17):1674–1680. Available from: https://pubmed.ncbi.nlm.nih.gov/28438841/
- Lattanzi S, Trinka E, Zaccara G, et al. Third-generation antiseizure medications for adjunctive treatment of focal-onset seizures in adults: a systematic review and network meta-analysis. Drugs. [Internet]. 2022 [cited 2022 Mar 21];82(2):199–218. Available from: https://pubmed.ncbi.nlm.nih.gov/35061214/
- Dental and Pharmaceutical Benefits Agency (TLV) [Internet]. [cited 2022 Mar 21]. Available from: https://www.tlv.se/om-oss/om-tlv.html