Brivaracetam Medicine 08 June 2021 Extended indication Extension of indication to include patients from 1 month to 4 years of age for the Briviact treatment, as a consequence. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Brivaracetam Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Extension of indication to include patients from 1 month to 4 years of age for the Briviact treatment, as a consequence. Current proprietary name Already available biosimilars / generics Proprietary name Briviact Manufacturer UCB Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Sodium channel antagonist; SV2A protein modulator. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2021 Expected Registration October 2021 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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