Perampanel

Active substance
Perampanel
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
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 for Fycompa

1. Product

Proprietary name
Fycompa
Manufacturer
Eisai
Mechanism of action
Receptor antagonist
Route of administration
Oral
Therapeutical formulation
Oral suspension
Budgetting framework
Extramural (GVS)
Additional comments
AMPA receptor antagonist

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
September 2019
Expected Registration
August 2020
Orphan drug
No
Registration phase
Registration application pending

3. 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.
Frequency of administration
1 times a day
Dosage per administration
4-12 mg
References
NCT02849626; SmPC
Additional comments
Dosering moet getitreerd worden voor maximaal effect.

4. Expected patient volume per year

Patient volume

50

Market share is generally not included unless otherwise stated.

References
GIPdatabank; CBS
Additional comments
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.

5. Expected cost per patient per year

Cost
1,000 - 1,100
References
GIPdatabank
Additional comments
In 2017 werd er per gebruiker €1.050 vergoed.

6. Potential total cost per year

Total cost

52,500

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.