Eptinezumab Medicine 03 June 2025 Extended indication Eptinezumab monotherapy for preventive treatment of with or without aura chronic Migraine in adolescents. 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 with or without aura chronic Migraine in adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Vyepti Manufacturer Lundbeck/Otsuka Portfolio holder Lundbeck/Otsuka 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 Particularity ATMP No Submission date December 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Tijdslijn op basis van IHSI-inschatting. 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 € 1,300.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References medicijnkosten.nl Additional remarks De prijs voor één 1ml flacon (100mg/ml) van eptinezumab (Vyepti) is €1.232,77 (exclusief BTW). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks