Cannabidiol Medicine 06 June 2023 Extended indication Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Cannabidiol Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam. Current proprietary name Already available biosimilars / generics Proprietary name Epidyolex Manufacturer GW Pharmaceuticals Portfolio holder Mechanism of action Cannabinoid Route of administration Oral Therapeutical formulation Solution Budgetting framework Extramural (GVS) Centre of expertise Additional remarks A small-molecule cannabinoid compound Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date September 2022 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De CHMP vond het bewijs niet overtuigend genoeg en zal daarom geen marktauthorisatie afgeven. Therapeutic value Current treatment options Op dit moment gegeven met enkel gegeven in combinatie met clobazam. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 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 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 Unknown Indication extensions References Additional remarks Other information Additional remarks