Eptinezumab Medicine 03 June 2025 Extended indication Eptinezumab monotherapy for preventive treatment of Chronic migraine in children over 6 years of age and adolescents with or without aura. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Eptinezumab Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Headache Extended indication Eptinezumab monotherapy for preventive treatment of Chronic migraine in children over 6 years of age and adolescents with or without aura. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Lundbeck Portfolio holder Mechanism of action CGRP-directed antibody Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date May 2026 Expected Registration December 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options CGRP-antagonisten zijn nog niet geregistreerd voor deze leeftijdsgroep. Bij kinderen zijn voor de aanvalsbehandeling van migraine paracetamol, eventueel met een anti-emeticum, de eerste keus. NSAID's zijn tweede keus. Triptanen zijn derde keus. Binnen de groep triptanen gaat de voorkeur uit naar sumatriptan neusspray op grond van bewezen werkzaamheid. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 100mg tot 300mg References NCT04965675 (PROSPECT-2) Additional remarks 100mg of 300mg enkelvoudige intraveneus-infusie. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1. Erfelijkheid.nl; Additional remarks In Nederland hebben ongeveer 200.000 kinderen onder de 16 jaar last van migraine (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks