RGN-259 Medicine 12 June 2018 Extended indication Dry eye Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance RGN-259 Domain Neurological disorders Reason of inclusion Main indication Eye disorders Extended indication Dry eye Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Regentree Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks ARISE-2 trial: mixed results. Synthetic version of an endogenous 43-amino acid hormone that reduces inflammation and has been shown to repair corneal damage in the animal dry eye model. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FDA wil extra fase 3 trial om effectiviteit verder aan te tonen. ARISE-3 wordt geïnitieerd. 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 Duration of treatment Frequency of administration 4 times a day Dosage per administration 1 oogdruppel References clinicaltrials.gov; Sosne et al. Cornea. 2015 May;34(5):491-6 Additional remarks ARISE-2 fase 3 studie RGN-259 vergeleken met placebo is nog niet gepubliceerd. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Onderstaande cijfers 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, afhankelijk van de therapeutische waarde. 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 Verwachting: vergelijkbaar met ciclosporin (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 Yes Indication extensions Neurotrophic Keratopathy References SPS Additional remarks Other information Additional remarks