Lacosamide Medicine 08 June 2021 Extended indication Extension of indication to include patients from 1 month to 4 years of age for treatment of partial-onset seizures with or without secondary generalisation as monotherapy and adjunctive therapy for Vimpat/Lacosamide USB. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lacosamide 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 treatment of partial-onset seizures with or without secondary generalisation as monotherapy and adjunctive therapy for Vimpat/Lacosamide USB. Current proprietary name Already available biosimilars / generics Proprietary name Vimpat Manufacturer UCB Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks CRMP2 protein modulator. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2021 Expected Registration November 2021 Orphan drug No 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