Cenegermin

Extended indication	Behandeling van matige (persisterend epitheeldefect) of ernstige (cornea ulcus) neurotrofische keratitis bij volwassenen.
Therapeutic value	No judgement
Total cost	86,700,000.00
Registration phase	Registered

Product

Active substance	Cenegermin
Domain	Neurological disorders
Reason of inclusion	New medicine (specialité)
Main indication	Eye disorders
Extended indication	Behandeling van matige (persisterend epitheeldefect) of ernstige (cornea ulcus) neurotrofische keratitis bij volwassenen.
Proprietary name	Oxervate
Manufacturer	Dompé
Mechanism of action	Growth factor
Route of administration	Ocular
Therapeutical formulation	Eye drops
Budgetting framework	Extramural (GVS)
Additional remarks	Werkingsmechanisme: 'Recombinant human nerve growth factor (rhNGF)'.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
Submission date	December 2016
Expected Registration	July 2017
Orphan drug	Yes
Registration phase	Registered
Additional remarks	Oxervate is per juli 2017 geregistreerd bij de EMA voor Keratitis. Nog geen vergoeding.

Therapeutic value

Therapeutic value	No judgement

Expected patient volume per year

Patient volume	1,700 - 8,500 Market share is generally not included unless otherwise stated.
References	Orphanet
Additional remarks	Neurotrofe keratinopathie komt voor bij 1-5 op de 10,000 mensen. Dit zijn 1.700-8.500 patiënten per 17 miljoen Nederlanders.

Patient volume

1,700 - 8,500

Market share is generally not included unless otherwise stated.

References

Orphanet

Additional remarks

Neurotrofe keratinopathie komt voor bij 1-5 op de 10,000 mensen. Dit zijn 1.700-8.500 patiënten per 17 miljoen Nederlanders.

Expected cost per patient per year

Cost	< 17,000.00
References	Cenegermin for treating neurotrophic keratitis, NICE 2018
Additional remarks	Een kuur van 8 weken kost in het VK £14,500 (~€17.000)

Potential total cost per year

Total cost	86,700,000.00 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

86,700,000.00

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.