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BEOVU (brolucizumab)

Opinions on drugs - Posted on Oct 10 2022

Reason for request

First assessment

Key points

Approval of reimbursement, in adults, for the treatment of visual impairment due to diabetic macular oedema, in the case of diffuse forms or leakages near the centre of the macula, in patients with visual impairment of 5/10 or less and for whom diabetes management has been optimized.

Disapproval of reimbursement in other cases.

Therapeutic improvement?

No improvement in relation to EYLEA (aflibercept), in adults, for the treatment of visual impairment due to diabetic macular oedema in the case of diffuse forms or leakages near the centre of the macula in patients with visual impairment of 5/10 or less and for whom diabetes management has been optimized.

Role in therapeutic strategy?

Optimising the management of diabetes and arterial hypertension is a prerequisite for any treatment of diabetic macular oedema.

Laser photocoagulation and intravitreal anti-VEGF agents are first-line treatments.

Focal laser photocoagulation is only used for focal forms of macular oedema located away from the fovea. Anti-VEGF agents are reserved for diffuse forms of macular oedema or focal oedema reaching the centre of the fovea in adults with visual impairment of 5/10 or less.

"Grid" photocoagulation can sometimes be considered in cases of diffuse oedema that do not respond to anti-VEGF agents.

In case of ischaemic territories (especially in the retinal periphery) and pre-retinal neovessels, pan-retinal laser photocoagulation can be used to prevent complications of proliferative forms of diabetic retinopathy (intravitreal haemorrhages, neovascular glaucoma and retinal detachment up to functional loss of the eye).

Local corticosteroids are available as intravitreal implants for treating diffuse DMO or with leakages near the centre of the macula. The OZURDEX dexamethasone implant may be used either as a first-line treatment in pseudophakic patients or as a second-line treatment in patients considered insufficiently responsive to non-corticosteroid therapy or for whom non-corticosteroid therapy is inappropriate. The ILUVIEN fluocinolone acetonide implant can be used after all other available therapies have failed. Intravitreal corticosteroid treatment can only be started after optimizing the management of diabetes and taking into account the tolerance profile of these drugs (risk of glaucoma, cataract).

Role of BEOVU (brolucizumab) in the therapeutic strategy:

Like LUCENTIS (ranibizumab) and EYLEA (aflibercept), BEOVU (brolucizumab) is a first-line treatment for visual impairment due to diabetic macular oedema in adults in the case of diffuse forms or leakages near the centre of the macula in patients with visual impairment of 5/10 or less and for whom diabetes management has been optimized. 

The choice between anti-VEGF agents [ranibizumab (LUCENTIS), aflibercept (EYLEA) and brolucizumab (BEOVU)] or OZURDEX (dexamethasone intravitreal implant) for the first-line treatment of pseudophakic patients is at the discretion of the ophthalmologist, who will take into account the ophthalmological characteristics of the treated eye [history of glaucoma or ocular hypertonia, status of the lens (phakic or pseudophakic), history of vitrectomy], the stage of diabetic retinopathy, cardiovascular history, the patient's age and the patient's ability to comply to the treatment.


Clinical Benefit
Substantial

The Committee deems that the actual clinical benefit of BEOVU (brolucizumab), as a solution for injection in pre-filled syringe and  solution for injection in vial, is SUBSTANTIAL, in adults, for the treatment of visual impairment due to diabetic macular oedema, in the case of diffuse forms or leakages near the centre of the macula in patients with visual impairment of 5/10 or less and for whom diabetes management has been optimized.
Insufficient

The Committee deems that the actual clinical benefit of BEOVU (brolucizumab), as a solution for injection in pre-filled syringe and  solution for injection in vial, is INSUFFICIENT in other cases to justify public funding with regard to the available alternatives.

Clinical Added Value
no clinical added value

Considering:

  • the evidence, after one year of treatment, of the non-inferiority of brolucizumab (BEOVU) compared to aflibercept (EYLEA) on the functional criterion (visual impairment), in adults with visual impairment due to DMO (BCVA of between 78 and 23 ETDRS letters inclusive) involving the centre of the macula, who have been on stable antidiabetic treatment for at least three months, and despite evidence of superiority on an anatomical criterion (central retinal thickness);
  • DMO involving the centre of the macula, with a central subfield retinal thickness ≥ 320 μm at selection;
  • the lack of evidence of superiority compared to aflibercept on long-term visual impairment, which would enable the validation of the correlation with the superiority outcome on the anatomical criterion;
  • the lack of robust evidence of an additional impact on quality of life,
  • the lack of comparison with the other available alternatives: ranibizumab (LUCENTIS) and dexamethasone implant (OZURDEX);
  • a safety comparable to aflibercept

the Committee deems that BEOVU 120 mg/ml (brolucizumab), as an solution for injection in pre-filled syringe and solution for injection in vial, provides no clinical added value (CAV V) compared to EYLEA (aflibercept), in adults, for the treatment of visual impairment due to diabetic macular oedema, in the case of diffuse forms or leakages close to the centre of the macula, in patients with visual impairment of 5/10 or less and for whom diabetes management has been optimized.

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