Ciclosporin

Active substance
Ciclosporin
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Eye disorders
Extended indication
Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.

1. Product

Proprietary name
Verkazia
Manufacturer
Santen
Mechanism of action
Immunosuppression
Route of administration
Ocular
Therapeutical formulation
Eye drops
Budgetting framework
Extramural (GVS)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Accelerated assessment
Submission date
December 2016
Expected Registration
July 2018
Orphan drug
Yes
Registration phase
Registered
Additional comments
Positieve CHMP opinie 21 juli 2017. Registratie in juli 2018.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found

4. Expected patient volume per year

Patient volume

< 870

Market share is generally not included unless otherwise stated.

References
EMA
Additional comments
Vernal keratoconjunctivitis affected between 1 to 3 in 10,000 people in Europe.' (EMA). Dit zijn 5.100 patiënten per 17 miljoen Nederlanders. Gezien de behandeling alleen van 4-18 jaar gegeven zal worden, en dit 17% van de Nederlandse bevolking betreft, komen er waarschijnlijk maximaal 870 patiënten in aanmerking voor deze behandeling.

5. Expected cost per patient per year

References
Medicijnkosten.nl
Additional comments
Flacon ciclosporin 10 ml, 1mg/ml: €37,04.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.