Citicoline Medicine 04 December 2025 Extended indication Citicoline in combination with intraocular pressure lowering agent for preventive treatment of progressing open angle glaucoma in adults and elderly. Therapeutic value No estimate possible yet Total cost € 26,000,000.00 Registration phase Clinical trials Product Active substance Citicoline Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Citicoline in combination with intraocular pressure lowering agent for preventive treatment of progressing open angle glaucoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Omikron Italia Portfolio holder Omikron Italia Mechanism of action Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fosfatidylcholinestimulant Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration June 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit een kleine trial bleek effect. Er loopt nu nog een fase 3 aanvullende therapie. Duration of treatment Frequency of administration 3 times a day Dosage per administration References NCT05710198 Additional remarks Driemaal daags één druppel in het oog. Expected patient volume per year Patient volume 120,000 - 140,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References VZinfo.nl Additional remarks In 2023 waren er ongeveer 384.600 mensen met glaucoom bekend bij de huisarts. POAG is meest voorkomende vorm van glaucoom. De prevalentie van POAG in Nederland is ongeveer 1%, dus rond de 200.000 mensen. Ongeveer 60 tot 70% daarvan wordt behandeld met medicatie. Expected cost per patient per year Cost € < 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 De kosten per patiënt per jaar voor latanoprost betreffen ongeveer €35, voor andere middelen ligt dit rond de €135. De verwachting is dat de kosten per patiënt per jaar voor citicoline hier tussenin liggen. Potential total cost per year Total cost € 26,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks