Cenegermin Medicine 09 January 2018 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. Current proprietary name Already available biosimilars / generics Proprietary name Oxervate Manufacturer Dompé Portfolio holder Mechanism of action Growth factor Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: 'Recombinant human nerve growth factor (rhNGF)'. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date December 2016 Expected Registration July 2017 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Oxervate is per juli 2017 geregistreerd bij de EMA voor Keratitis. Nog geen vergoeding. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 1,700 - 8,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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. 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks