Perampanel Medicine 12 June 2019 Extended indication Extension of indication to include adjunctive treatment in paediatric patients from 2 to 11 years of age in Partial-Onset (focal) Seizures with or without secondary generalisation and Primary Generalised Tonic-Clonic Seizures with idiopathic generalised epilepsy for Fycompa Therapeutic value No judgement Total cost € 52,500.00 Registration phase Registration application pending Product Active substance Perampanel Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Extension of indication to include adjunctive treatment in paediatric patients from 2 to 11 years of age in Partial-Onset (focal) Seizures with or without secondary generalisation and Primary Generalised Tonic-Clonic Seizures with idiopathic generalised epilepsy for Fycompa 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 August 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Overige anti-epileptica Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Perampanel 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