BEOVU (brolucizumab)

Key points

Unfavourable opinion for reimbursement for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.

Role in the care pathway?

Currently, the treatment of exudative AMD is based on intravitreal (IVT) injections of anti-VEGF, which make it possible to stabilise or improve patients’ vision but cannot cure the condition. Two anti-VEGF therapies that already have an MA in this indication are used in France: ranibizumab (LUCENTIS) and aflibercept (EYLEA). Another anti-VEGF therapy is available in this indication: bevacizumab (AVASTIN). It is the subject of a Temporary Recommendation for use (RTU) granted by the ANSM in AMD.

There are different protocols for the treatment of AMD using anti-VEGF therapy, such as, notably, the fixed-interval injection regimen (monthly or two-monthly injections depending on the drug used), or personalised regimens, such as the “Treat and Extend” protocol aimed at reducing the frequency of injections and visits depending on disease activity, or the IOI (injection – observation – individualisation) protocol proposed by the France Macula Federation.

Role of the medicinal product in the care pathway

 In the first-line treatment of neovascular (wet) age-related macular degeneration, taking into account the following elements:

• the demonstrated non-inferiority of brolucizumab compared to aflibercept in terms of the mean variation in best corrected visual acuity (non-inferiority margin of -4 letters) and
• its demonstrated superiority on ranked secondary endpoints (central retinal thickness, presence of intraretinal/subretinal fluid and investigator-assessed disease activity),

but also:

• its ocular safety profile, marked by a higher frequency of ocular serious adverse events (AEs) compared to aflibercept (3.4% versus 1.5%), and especially
• an additional risk of retinal vasculitis and/or retinal vascular occlusion, which are serious AEs since they can lead to severe visual acuity loss, not currently characterised with the other available anti-VEGF therapies,

the Transparency Committee considers that BEOVU (brolucizumab) has no role in the first-line treatment of neovascular (wet) age-related macular degeneration.

As second or later-line treatment, despite an identified medical need in the event of failure of the anti-VEGF therapies already available (resistance, intolerance, contraindication), the role of BEOVU (brolucizumab) in this situation cannot be determined due to the lack of available data.