Masitinib Medicine 09 January 2018 Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Masitinib Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication ALS Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole. Current proprietary name Already available biosimilars / generics Proprietary name Alsitek Manufacturer AB Science Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2022 Expected Registration September 2023 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP april 2018. Herbeoordeling gestart in april 2018. Fabrikant heeft de aanvraag tot herbeoordeling ingetrokken in mei 2018. Opnieuw ingediend bij de EMA. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 4,5 of 6,0 mg/kg lichaamsgewicht References NCT03127267 Additional remarks masitinib (1x daags) wordt samen gegeven met 50mg riluzole (2x daags) Expected patient volume per year Patient volume < 1,280 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks 1.280 gebruikers riluzol (GIP databank 2021), maximaal volume. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Onderzocht in verschillende indicatiegebieden. De eerstvolgende indicatie-uitbreidingen zijn op de scan opgenomen. References Additional remarks Other information Additional remarks