Ciclosporin Medicine 09 January 2018 Extended indication Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe and specifically in patients with atopic keratoconjunctivitis. Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Ciclosporin Domain Neurological disorders Reason of inclusion Main indication Eye disorders Extended indication Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe and specifically in patients with atopic keratoconjunctivitis. Current proprietary name Already available biosimilars / generics Proprietary name Restaysis Manufacturer Allergan Portfolio holder Mechanism of action Unknown 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 Normal trajectory Particularity Indication extension ATMP Unknown Submission date December 2016 Expected Registration Orphan drug Yes Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Restasis is al een tijd in de VS geregistreerd.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'. Registratieaanvraag teruggetrokken in mei 2018. Fabrikant geeft aan dat dit besluit is genomen omdat de CHMP de huidige data niet doorslaggevend is. Klinische studies zullen wel gewoon doorgaan. 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 1 times a day Dosage per administration 1 druppel van emulsie, 1 mg/ml References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 17 miljoen Nederlanders.' (EMA) Een deel van deze patiënten betreft de categorie moderate to severe en zal afhankelijk van de therapeutische waarde bij een deel van deze groep patiënten worden ingezet. Expected cost per patient per year Cost € 1,000.00 - 1,500.00 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. References Medicijnkosten.nl Additional remarks Flacon ciclosporin 10 ml, 1mg/ml: €37,03. 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