Amifampridine Medicine 07 December 2021 Extended indication Symptomatische behandeling van het Lambert-Eaton-myastheniesyndroom (LEMS) bij volwassenen. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Amifampridine Domain Neurological disorders Reason of inclusion Generic G Main indication Muscular diseases other Extended indication Symptomatische behandeling van het Lambert-Eaton-myastheniesyndroom (LEMS) bij volwassenen. Current proprietary name Firdapse (SERB SA) Already available biosimilars / generics geen Proprietary name Amifampridine SERB Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Acetylcholine stimulants; Potassium channel antagonists Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date May 2021 Expected Registration May 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Geen geldig patent gevonden in het octrooi register. Positieve CHMP opinie ontvangen in maart 2022. Therapeutic value Current treatment options Therapeutic value Possible equal value 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