Ciclosporin Medicine 09 January 2018 Extended indication Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Ciclosporin Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Verkazia Manufacturer Santen Portfolio holder Mechanism of action Immunosuppression Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date December 2016 Expected Registration July 2018 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie 21 juli 2017. Registratie in juli 2018. 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 < 870 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks Vernal keratoconjunctivitis affected between 1 to 3 in 10,000 people in Europe.' (EMA). Dit zijn 5.100 patiënten per 17 miljoen Nederlanders. Gezien de behandeling alleen van 4-18 jaar gegeven zal worden, en dit 17% van de Nederlandse bevolking betreft, komen er waarschijnlijk maximaal 870 patiënten in aanmerking voor deze behandeling. Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks Flacon ciclosporin 10 ml, 1mg/ml: €37,04. Potential total cost per year Total cost 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