Ciclosporin

Extended indication	Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe and specifically in patients with atopic keratoconjunctivitis.
Therapeutic value	No judgement
Total cost	3,187,500.00

Product

Active substance	Ciclosporin
Domain	Neurological disorders
Main indication	Eye disorders
Extended indication	Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe and specifically in patients with atopic keratoconjunctivitis.
Proprietary name	Restatis
Manufacturer	Allergan
Route of administration	Ocular
Therapeutical formulation	Eye drops
Budgetting framework	Extramural (GVS)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	December 2016
Expected Registration	2018
Orphan drug	Yes
Additional remarks	Restasis is al een tijd in de VS geregistreerd. Door de EMA is een andere ciclosporine oogdruppel, namelijk Ikerivis, als weesgeneesmiddel geregistreerd voor 'ernstige keratitis bij patiënten met het droge ogen syndroom die niet is verbeterd ondanks behandeling met traanvervangende middelen'.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Not found
Frequency of administration	1 times a day
Dosage per administration	1 druppel van emulsie, 1 mg/ml

Expected patient volume per year

Patient volume	< 2,550 Market share is generally not included unless otherwise stated.
References	EMA
Additional remarks	Atopic keratoconjunctivitis affected approximately 1.5 in 10,000 people in the European Union (EU). Dit zijn 2.550 patiënten per 17M Nederlanders.' (EMA)

Patient volume

< 2,550

Market share is generally not included unless otherwise stated.

References

EMA

Additional remarks

Atopic keratoconjunctivitis affected approximately 1.5 in 10,000 people in the European Union (EU). Dit zijn 2.550 patiënten per 17M Nederlanders.' (EMA)

Expected cost per patient per year

Cost	1,000.00 - 1,500.00
References	Medicijnkosten.nl
Additional remarks	Flacon ciclosporin 10 ml, 1mg/ml: €37,03.

Potential total cost per year

Total cost	3,187,500.00 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.

Total cost

3,187,500.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.