Extended indication Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Pitolisant
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Sleep disorders
Extended indication Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years.
Proprietary name Wakix
Manufacturer bioprojet1
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2022
Expected Registration May 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value Possible added value
Dosage per administration nog niet bekend

Expected patient volume per year

Additional comments Nog niet bekend

Expected cost per patient per year

References medicijnkosten.nl
Additional comments De huidige behandeling kost < 4500 euro per jaar gezien het een behandeling van < 12 euro betreft voor 18 mg tabletten 1 maal per dag. Het is nog onduidelijk of ook hier een dosering van 18 mg per dag zal komen te gelden, indien dat het geval is zullen de kosten ook maximaal 4500 euro per patient per jaar kosten.

Potential total cost per year

Additional comments Nog niet bekend

Off label use

Additional comments Nog niet bekend

Indication extension

Indication extension Yes
Additional comments Betreft uitbreiding naar kinderen vanaf 6 jaar,

Other information

There is currently no futher information available.