Extended indication Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older wi
Therapeutic value No estimate possible yet
Total cost 316,525.00
Registration phase Positive CHMP opinion

Product

Active substance Dimethyl fumarate
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Multiple sclerosis
Extended indication Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Proprietary name Tecfidera
Manufacturer Biogen
Portfolio holder 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 June 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMp opinie ontvangen in januari 2022. Na een herbeoordeling op verzoek van de fabrikant, heeft de CHMP haar oordeel opnieuw gegeven in april 2022.

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

Patient volume

< 55

Market share is generally not included unless otherwise stated.

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. Aangezien ook bij kinderen jonger dan 13 jaar MS wordt gediagnosticeerd is het verwachte patiëntvolume lager dan 55.

Expected cost per patient per year

Cost < 5,755.00
References GIPdatabank
Additional comments In 2021 werd er per volwassen gebruiker €5.755 vergoed. Dit valt mogelijk lager uit voor deze indicatie-uitbreiding

Potential total cost per year

Total cost

316,525.00

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.

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.