Cenegermin

Active substance
Cenegermin
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Eye disorders
Extended indication
Behandeling van matige (persisterend epitheeldefect) of ernstige (cornea ulcus) neurotrofische keratitis bij volwassenen.

1. Product

Proprietary name
Oxervate
Manufacturer
Dompé
Mechanism of action
Growth factor
Route of administration
Ocular
Therapeutical formulation
Eye drops
Budgetting framework
Extramural (GVS)
Additional comments
Werkingsmechanisme: 'Recombinant human nerve growth factor (rhNGF)'.

2. 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 comments
Oxervate is per juli 2017 geregistreerd bij de EMA voor Keratitis. Nog geen vergoeding.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found

4. Expected patient volume per year

Patient volume

1,700 - 8,500

Market share is generally not included unless otherwise stated.

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

5. Expected cost per patient per year

Cost
< 17,000
References
Cenegermin for treating neurotrophic keratitis, NICE 2018
Additional comments
Een kuur van 8 weken kost in het VK £14,500 (~€17.000)

6. Potential total cost per year

Total cost

86,700,000

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

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.