Faricimab Medicine 05 December 2023 Extended indication Extension of indication to include treatment of adult patients with visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). Therapeutic value Possible benefit in ease of use Total cost € 26,280,000.00 Registration phase Registered and reimbursed Product Active substance Faricimab Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Eye disorders Extended indication Extension of indication to include treatment of adult patients with visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). Current proprietary name Already available biosimilars / generics Proprietary name Vabysmo Manufacturer Roche Portfolio holder Roche Mechanism of action Angiogenesis inhibitor Route of administration Intravitreal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Angiopoietin-2 inhibitors; Vascular endothelial growth factor A inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration July 2024 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks In april 2025 is in Staatscourant gepubliceerd dat de sluis is opgeheven voor Vabysmo (faricimab) voor behandeling van volwassen patiënten met visusverslechtering als gevolg van macula-oedeem secundair aan retinale veneuze occlusies (veneuze takocclusie of retinale veneuze stamocclusie). Staatscourant 2025, 11558 | Overheid.nl > Officiële bekendmakingen. Therapeutic value Current treatment options Anti-VEGFs: bevacizumab, ranibizumab, aflibercept Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Het voordeel van dit geneesmiddel is dat het minder vaak intra-oculair geïnjecteerd hoeft te worden (iedere 4 maanden). Het kan worden toegepast bij alle VEGF gemedieerde oogziektes en kan daarmee de plaats van ranibizumab en aflibercept potentieel gaan innemen en daarmee een grote kostenbesparing opleveren als de prijs overeenkomstig met die van de andere geneesmiddelen is. Duration of treatment Frequency of administration 1 times every 4 months Dosage per administration 6mg References Registratie studies COMINO (CRVO) en BALATON (BRVO) NCT04740905. Additional remarks Expected patient volume per year Patient volume < 9,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Sluisadvies faricimab augustus 2024; expertopinie Additional remarks Uitgaande van de geregistreerde indicatie en de inzet van Anti‑VEGF medicijnen bij CRVO en BRVO wordt faricimab naar verwachting ingezet na non-respons op intravitreaal bevacizumab. In 2023 waren er ongeveer 9.000 patiënten in de tweede lijn voor macula-oedeem door BRVO of CRVO (volwassenen). Expected cost per patient per year Cost € 2,920.00 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 Z-index Additional remarks De lijstprijs van faricimab is €730 per 6mg. Dit komt neer op €2.920 per jaar bij vier giften. Potential total cost per year Total cost € 26,280,000.00 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