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oai:recercat.cat:11351/90702025-10-24T10:28:40Zcom_2072_378070com_2072_378040col_2072_378092

Number needed to treat and associated cost analysis of cenobamate versus third-generation anti-seizure medications for the treatment of focal-onset seizures in patients with drug-resistant epilepsy in Spain Serratosa, José M. Toledo Argany, Manuel Calleja‐Hernández, Miguel Ángel Navarro, Andrés Sabaniego, Joel Villanueva, Vicente Institut Català de la Salut [Villanueva V] Hospital Universitari i Politècnic La Fe, Valencia, Spain. [Serratosa JM] Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain. [Toledo M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Ángel Calleja M] Hospital Universitario Virgen Macarena, Sevilla, Spain. [Navarro A] Hospital General Universitario de Elche, Alicante, Spain. [Sabaniego J] Angelini Pharma, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Epilèpsia Anticonvulsius Resistència als medicaments Cost-eficàcia DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Epilepsy::Drug Resistant Epilepsy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Central Nervous System Agents::Anticonvulsants HEALTH CARE::Health Care Economics and Organizations::Economics::Costs and Cost Analysis ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::epilepsia::epilepsia resistente a los medicamentos COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos del sistema nervioso central::anticonvulsivantes ATENCIÓN DE SALUD::economía y organizaciones para la atención de la salud::economía::costes y análisis de costes Medicamentos anticonvulsivos; Cenobamato; Eficiencia Medicaments anticonvulsius; Cenobamat; Eficiència Anti-seizure medications; Cenobamate; Efficiency Introduction Epilepsy is a serious neurological disease, ranking high in the top causes of disability. The main goal of its treatment is to achieve seizure freedom without intolerable adverse effects. However, approximately 40% of patients suffer from Drug-Resistant Epilepsy (DRE) despite the availability of the latest options called third-generation Anti-Seizure Medications(ASMs). Cenobamate is the first ASM approved in Spain for the adjunctive treatment of Focal-Onset Seizures (FOS) in adult patients with DRE. The introduction of a new drug increases the number of therapeutic options available, making it important to compare it with existing alternatives in terms of clinical benefit and efficiency. Purpose This study aimed to compare the clinical benefit, in terms of the Number Needed to Treat (NNT), and the efficiency, in terms of Cost per NNT (CNT), associated with cenobamate versus third-generation ASMs used in Spain for the adjunctive treatment of FOS in patients with DRE. Methods The Number Needed to Treat data was calculated based on the ≥50% responder rate and seizure freedom endpoints (defined as the percentage of patients achieving 50% and 100% reduction in seizure frequency, respectively), obtained from pivotal clinical trials performed with cenobamate, brivaracetam, perampanel, lacosamide, and eslicarbazepine acetate. The NNT was established as the inverse of the treatment responder rate minus the placebo responder rate and was calculated based on the minimum, mid-range Daily Defined Dose (DDD), and maximum doses studied in the pivotal clinical trials of each ASM. CNT was calculated by multiplying the annual treatment cost by NNT values for each treatment option. Results In terms of NNT, cenobamate was the ASM associated with the lowest values at all doses for both ≥50% responder rate and seizure freedom compared with the alternatives. In terms of CNT, for ≥50% responder rate, cenobamate was the ASM associated with the lowest CNT values at DDD and lacosamide and eslicarbazepine acetate at the minimum and maximum dose, respectively. For seizure freedom, cenobamate was associated with the lowest CNT value at DDD and the maximum dose and lacosamide at the minimum dose. Conclusions Cenobamate could represent the most effective ASM in all doses studied compared to the third-generation ASMs and the most efficient option at DDD for both ≥50% responder rate and seizure freedom. This study could represent an important contribution towards informed decision-making regarding the selection of the most appropriate therapy for FOS in adult patients with DRE from a clinical and economical perspective in Spain. This study was sponsored by Angelini Pharma España, S.L.U. 2023-02-28T07:11:03Z 2023-02-28T07:11:03Z 2023-02 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Villanueva V, Serratosa JM, Toledo M, Ángel Calleja M, Navarro A, Sabaniego J, et al. Number needed to treat and associated cost analysis of cenobamate versus third-generation anti-seizure medications for the treatment of focal-onset seizures in patients with drug-resistant epilepsy in Spain. Epilepsy Behav. 2023 Feb;139:109054. 1525-5050 https://hdl.handle.net/11351/9070 10.1016/j.yebeh.2022.109054 36603345 000919505700001 http://hdl.handle.net/11351/9070 eng Epilepsy & Behavior;139 https://doi.org/10.1016/j.yebeh.2022.109054 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia