Extended indication Extension of indication to include treatment of relapsing remitting multiple sclerosis (RRMS) in pae
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Dimethyl fumarate
Domain Neurological disorders
Reason of inclusion Indication extension
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.
Proprietary name Tecfidera
Manufacturer Biogen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional comments NF E2 related factor 2 stimulants; NF-kappa B inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2021
Expected Registration March 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Interferon-β, fingolimod and glatirameeracetaat hebben een registratie voor deze patiëntengroep.
Therapeutic value No estimate possible yet
Substantiation In de klinische studie wordt dimethyl fumarate vergeleken met Interferon-β.
Dosage per administration 120 mg, 240 mg
References NCT02283853 (CONNECT)

Expected patient volume per year

References De Mol et al. J Neurol. 2018 Jun;265(6):1310-1319
Additional comments 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

References Medicijnkosten
Additional comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.