Pitolisant Medicine 07 December 2022 Extended indication Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years. Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Pitolisant Domain Neurological disorders Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Wakix Manufacturer Bioprojet1 Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2022 Expected Registration May 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration nog niet bekend References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Nog niet bekend Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks 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 Total cost Total cost for sluice Additional remarks Nog niet bekend Off label use Off label use Unknown Indications off label use References Additional remarks Nog niet bekend Indication extension Indication extensions Yes Indication extensions References Additional remarks Betreft uitbreiding naar kinderen vanaf 6 jaar, Other information Additional remarks