KPI-121 Medicine 12 June 2018 Extended indication Dry eye disease. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance KPI-121 Domain Neurological disorders Reason of inclusion Main indication Eye disorders Extended indication Dry eye disease. Current proprietary name Already available biosimilars / generics Proprietary name Inveltys Manufacturer Kala Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Pipeline watch 12 januari 2018: STRIDE 1, 2; met not all primary endpoints; mixed results Phase III Interim/Top-line Results. Glucocorticoid receptor agonists. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Prednisolon 0,05% en 0,1 % en dexamethason oogdruppels. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Mixed results fase III trials, na 15 dagen werden primary endpoints niet allen gehaald (met name in STRIDE-2). Duration of treatment Frequency of administration Dosage per administration 0,25% 1 oogdruppel References STRIDE 1 and 2 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Onderstaande gegevens zijn op basis van Lifitegrast. Additional remarks Afhankelijk van de uiteindelijke labelling en plaats in de behandelrichtlijn. Prevalentie van ernstige DED is 2% - 5% (340.000 - 850.000 patiënten). Nog onbekend bij hoeveel patiënten het uiteindelijk ingezet gaat worden, dit is afhankelijk van de therapeutische waarde. Expected cost per patient per year Cost € 100.00 - 200.00 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 GIPdatabank Additional remarks Verwachte kosten vergelijkbaar met Prednisolon en dexamethason oogdruppels. Kosten per gebruiker 2016 prednisolon €103,50, kosten per gebruiker 2016 dexamethason €183,40. 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 Yes Indication extensions ocular pain and inflammation. References Scrip, clinicaltrials.gov. Additional remarks Other information Additional remarks