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Perampanel

Fycompa

Extended indication Extension of Indication to include adjunctive treatment in paediatric patients from 2 to 11 years of
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
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.
Proprietary name Fycompa
Manufacturer Eisai
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Oral suspension
Budgetting framework Extramural (GVS)
Additional remarks AMPA receptor antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2019
Expected Registration December 2019
Registration phase Registration application pending

Therapeutic value

Current treatment options Overige anti-epileptica
Therapeutic value No judgement
Substantiation Perampanel met name interessant voor patiënten die niet uitkomen met de huidige behandelopties.
Duration of treatment continuous
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.
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 1,050.00
References GIPdatabank
Additional remarks In 2017 werd er per gebruiker €1.050 vergoed.

Potential total cost per year

Total cost

52,500.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Lennox-Gastaut syndrome
References Eisai pipeline; NCT02834793

Other information

There is currently no futher information available.