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Faricimab

Vabysmo

Extended indication

Extension of indication to include treatment of adult patients with visual impairment due to macular

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

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)
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

September 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.