Favourable opinion for reimbursement “the treatment of neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults”.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
VABYSMO (faricimab) is a first-line treatment for neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults.
The choice between anti-VEGF therapies as first-line treatment is left to the decision of the ophthalmologist.
Special recommendations
The Committee recommends exception drug status.
Clinical Benefit
Substantial
The clinical benefit of VABYSMO (faricimab) 120 mg/mL solution for injection is substantial in the treatment of neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults.
Insufficient
The clinical benefit of VABYSMO (faricimab) 120 mg/mL solution for injection is insufficient in other cases to justify public funding in view of the available alternatives.
Clinical Added Value
no clinical added value
Considering:
evidence of the non-inferiority of VABYSMO (faricimab, using a QW8/QW12/QW16 personalised administration regimen) compared to EYLEA (aflibercept, using a Q8W fixed administration regimen), based on the functional endpoint of visual acuity, in two randomised, double-blind, phase 3 trials in adults with neovascular (wet) age-related macular degeneration (AMD) and who are treatment-naïve;
the absence of a comparison between faricimab administered using a personalised regimen and aflibercept administered using a “Treat-and-Extend” regimen;
the lack of robust evidence of an additional impact on quality life or on the patient’s care and life pathway (particularly in terms of a reduction in the frequency of injections) compared to the available alternatives;
safety comparable to that recorded for aflibercept;
the Committee deems that VABYSMO (faricimab) solution for injection provides no clinical added value (CAV V) compared to EYLEA (aflibercept) solution for injection in pre-filled syringe in the treatment of neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults.
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