Fremanezumab Medicine 03 June 2025 Extended indication Fremanezumab monotherapy for preventive treatment of Chronic migraine, Episodic migraine in children over 6 years of age and adolescents. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Fremanezumab Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Headache Extended indication Fremanezumab monotherapy for preventive treatment of Chronic migraine, Episodic migraine in children over 6 years of age and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Ajovy Manufacturer Teva Portfolio holder Teva Mechanism of action CGRP-directed antibody Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Calcitonin gene-related peptide receptor antagonist. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration January 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice 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. NSAIDʼs 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 References NCT04530110; NCT04458857 (SPACE); NCT04464707 Additional remarks Expected patient volume per year Patient volume < 200,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Erfelijkheid.nl(1) 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 Medicijnkosten.nl Additional remarks AJOVY injectievloeistof 150mg/ml PEN 1,5ml €381,50 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