Tarcocimab tedromer Medicine 04 June 2024 Extended indication Macular edema due to retinal vein occlusion (RVO) Therapeutic value Possible benefit in ease of use Total cost Registration phase Clinical trials Product Active substance Tarcocimab tedromer Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Macular edema due to retinal vein occlusion (RVO) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Kodiac Portfolio holder Mechanism of action Unknown Route of administration Intravitreal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Kodiac Sciences Vascular endothelial growth factors inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT04592419 Therapeutic value Current treatment options Bevacizumab en aflibercept worden op dit moment off-label gegeven. Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Een voordeel is de toediening van eenmaal per 2 maanden ten opzichte van de huidige opties. Het betreft een VEGF-remmer en werkt op dezelfde aangrijpingspunten als de andere beschikbare geneesmiddelen. Duration of treatment Frequency of administration 1 times every 2 months Dosage per administration 5mg References NCT04592419 Additional remarks Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Laouri M, Chen E, Looman M, Gallagher M. The burden of disease of retinal vein occlusion: review of the literature. Eye (Lond). 2011 Aug;25(8):981-8. doi: 10.1038/eye.2011.92. Epub 2011 May 6. PMID: 21546916; PMCID: PMC3178209. Additional remarks Bevolkingsstudies rapporteren een prevalentie van 0,5-2,0% van BVRO en 0,1-0,2% voor CRVO. Ongeveer 5-15% van de ogen met BRVO ontwikkelt macula-oedeem gedurende 1 jaar. 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