IBI311 Medicine 03 December 2024 Extended indication Tyroid Eye disease Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance IBI311 Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Tyroid Eye disease Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Innovent Biologics Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IGF type 1 receptor antagonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date May 2025 Expected Registration June 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Inschatting patiëntvolume teprotumumab; schildklier.nl Additional remarks Ongeveer 75.000 mensen hebben de ziekte van Graves, 20% daarvan heeft de oogaandoening Graves oftalmopathie. Ongeveer 5% loopt het risico de oogziekte in ernstige vorm te ontwikkelen (3.750). Gezien de inclusiecriteria van de klinische studie zal het vooral gaan om deze laatste groep patiënten. Potentieel is dit dus een erg grote groep. Veel zal afhangen van de precieze indicatiestelling en is afhankelijk van de activiteit score (CAS) die geïncludeerd wordt en of alleen inflammatoire fase of ook fibrotische fase van de orbitopathie behandeld zal worden. Het is vooralsnog onduidelijk hoeveel patiënten hiervoor in aanmerking zullen komen, zeker gezien de mogelijke prijsstelling. Expected cost per patient per year Cost References Additional remarks 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