Ciclosporin

Extended indication	Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
Therapeutic value	No judgement

Product

Active substance	Ciclosporin
Domain	Neurological disorders
Main indication	Eye disorders
Extended indication	Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
Proprietary name	Verkazia
Manufacturer	Santen
Route of administration	Ocular
Therapeutical formulation	Eye drops
Budgetting framework	Extramural (GVS)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
Submission date	December 2016
Expected Registration	January 2018
Orphan drug	Yes
Additional remarks	Positieve CHMP opnie 21 juli 2017.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Not found

Expected patient volume per year

Patient volume	< 5,100 Market share is generally not included unless otherwise stated.
References	EMA
Additional remarks	Vernal keratoconjunctivitis affected between 1 to 3 in 10,000 people in the European Union (EU).' (EMA) Dit zijn 5.100 patienten per 17M Nederlanders.

Patient volume

< 5,100

Market share is generally not included unless otherwise stated.

References

EMA

Additional remarks

Vernal keratoconjunctivitis affected between 1 to 3 in 10,000 people in the European Union (EU).' (EMA) Dit zijn 5.100 patienten per 17M Nederlanders.

Expected cost per patient per year

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

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.