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 Registered 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 Bioprojet 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 February 2023 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie in januari 2023. 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 € < 5,162.00 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. References GIPdatabank; EPAR Additional remarks In 2021 werd er per volwassen gebruiker €5.162 vergoedt. Bij de jonge patiënten zal de dosering lager zijn dan bij de volwassenen. Dit zal per patiënt moeten worden bepaald maar geldt hetzelfde maximum als bij de volwassenen. 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