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 Receptor antagonist Route of administration Intravitreal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Kodiac Sciences Vascular endothelial growth factors (VEGF) inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2026 Expected Registration September 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks BEACON trial (NCT04592419); NCT03790852 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 twee 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 Intravitreale injectie van KSI-301 (5mg) op dag 1, week 4 en eenmaal per 8 weken tot en met week 20, gevolgd door een individueel doseringsschema van intravitreale injectie van KSI-301 (5mg) van week 24 tot en met 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 tot 2,0% van BVRO en 0,1 tot 0,2% voor CRVO. Ongeveer 5 tot 15% van de ogen met BRVO ontwikkelt macula-oedeem gedurende 1 jaar. Expected cost per patient per year Cost € 3,700.00 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 Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (S01LA - anti‑neovascularisatie middelen) geneesmiddelen in Nederland. Potential total cost per year Total cost 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