Perampanel Medicine 12 June 2019 Extended indication Fycompa (perampanel) is indicated for the adjunctive treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older. Primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy (IGE). Therapeutic value No estimate possible yet Total cost € 52,500.00 Registration phase Registered and reimbursed Product Active substance Perampanel Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Fycompa (perampanel) is indicated for the adjunctive treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older. Primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy (IGE). Current proprietary name Already available biosimilars / generics Proprietary name Fycompa Manufacturer Eisai Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Oral suspension Budgetting framework Extramural (GVS) Centre of expertise Additional remarks AMPA receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2019 Expected Registration November 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2020. Therapeutic value Current treatment options Overige anti-epileptica Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Perampanel is met name interessant voor patiënten die niet uitkomen met de huidige behandelopties. Duration of treatment Frequency of administration 1 times a day Dosage per administration 4-12 mg References NCT02849626; SmPC Additional remarks Dosering moet getitreerd worden voor maximaal effect. Expected patient volume per year Patient volume 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank; CBS Additional remarks In 2017 waren er 522 gebruikers van perampanel. Dit zijn patiënten van >12 jaar. De verhouding tussen de bevolkingsgroep 4-12 jaar en die van >12 jaar is ongeveer 1:10. Aangenomen dat er een gelijke verdeling van de indicatie plaatsvindt zouden er ongeveer 50 patiënten verwacht kunnen worden voor deze indicatie. Expected cost per patient per year Cost € 1,000.00 - 1,100.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIPdatabank Additional remarks In 2017 werd er per gebruiker €1.050 vergoed. Potential total cost per year Total cost € 52,500.00 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 Lennox-Gastaut syndrome References Eisai pipeline; NCT02834793 Additional remarks Other information Additional remarks