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Faricimab

Vabysmo

Extended indication Bloedvat afsluiting in netvlies (BRVO/CRVO)
Therapeutic value Possible benefit in ease of use
Registration phase Registration application pending

Product

Active substance Faricimab
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Eye disorders
Extended indication Bloedvat afsluiting in netvlies (BRVO/CRVO)
Proprietary name Vabysmo
Manufacturer Roche
Portfolio holder Roche
Mechanism of action Angiogenesis inhibitor
Route of administration Intravitreal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Angiopoietin-2 inhibitors; Vascular endothelial growth factor A inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2023
Expected Registration June 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Anti-VEGFs: bevacizumab, ranibizumab, aflibercept
Therapeutic value Possible benefit in ease of use
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.
Frequency of administration 1 times every 4 months
Dosage per administration 6mg
References Registratie studies COMINO (CRVO) en BALATON (BRVO) NCT04740905.

Expected patient volume per year

Additional remarks De incidentie van retinal vein occlusion is 0,5% tot 2%.

Expected cost per patient per year

Cost 2,920.00
References Z-index
Additional remarks De lijstprijs van faricimab is €730 per 6mg. Dit komt neer op €2.920 per jaar bij 4 giften.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.