Dimethyl fumarate Medicine 07 December 2021 Extended indication Extension of indication to include treatment of relapsing remitting multiple sclerosis (RRMS) in paediatrics patients from 10 years of age and over. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Dimethyl fumarate Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Multiple sclerosis Extended indication Extension of indication to include treatment of relapsing remitting multiple sclerosis (RRMS) in paediatrics patients from 10 years of age and over. Current proprietary name Already available biosimilars / generics Proprietary name Tecfidera Manufacturer Biogen Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks NF E2 related factor 2 stimulants; NF-kappa B inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2021 Expected Registration March 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Interferon-β, fingolimod and glatirameeracetaat hebben een registratie voor deze patiëntengroep. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de klinische studie wordt dimethyl fumarate vergeleken met Interferon-β. Duration of treatment Frequency of administration Dosage per administration 120 mg, 240 mg References NCT02283853 (CONNECT) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De Mol et al. J Neurol. 2018 Jun;265(6):1310-1319 Additional remarks Er zijn in Nederland circa 55 kinderen met multiple sclerose. Hiervan wordt op dit moment 90% behandeld, met name met interferon-β en 10%-15% staat momenteel op een 2e-lijns behandeling. Expected cost per patient per year Cost References Medicijnkosten Additional remarks Pedriatische indicatie, kosten en/of dosering kan mogelijk afwijken ten opzichte van volwassenen. Kosten volwassenen:120 mg = €11,09 per stuk , voor 240 mg 21,25 per stuk 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