Renewal of inclusion and Re-assessment of IAB at the company's request in accordance with article R.163 12 of the Social Security Code (CSS) in the indication: “Treatment of visual impairment due to diabetic macular oedema (DME)”.
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Clinical Benefit
Insufficient
DME : The actual benefit of LUCENTIS 10 mg/ml is remains insufficient in the other situations.
Substantial
AMD : The actual benefit of LUCENTIS 10 mg/ml is still substantial in the treatment of exsudative age-related macular degeneration (AMD) with subfoveal choroidal neovascularisation.
DME : The actual benefit of LUCENTIS 10 mg/ml is still substantial in patients with visual impairment of 5/10 or less as a result of diabetic macular oedema in diffuse forms of the disease or with leaks close to the centre of the macula in whom diabetic care has been optimised.
Branch RVO and central RVO : The actual benefit of LUCENTIS 10 mg/ml remains substantial in the treatment of visual impairment due to macular oedema secondary to branch RVO or central RVO.
Clinical Added Value
important
AMD : In light of the data submitted, the Committee deems that the substantial improvement in actual benefit (IAB II) for LUCENTIS 10 mg/ml is maintained for the management of patients suffering from exsudative AMD with subfoveal choroidal neovascularisation.
minor
DME : In light of the data submitted, the Committee deems that the minor improvement in actual benefit (IAB IV) for LUCENTIS 10 mg/ml is maintained in the treatment strategy for visual impairment due to diabetic macular oedema in diffuse forms of the disease or with leaks close to the centre of the macula in patients whose visual acuity is 5/10 or less and in whom diabetic care has been optimised.
Branch RVO and central RVO : In view of the absence of new data, the Committee deems that the minor improvement in actual benefit (IAB IV) for LUCENTIS 10 mg/ml compared with OZURDEX is maintained in the treatment of visual impairment due to macular oedema secondary to branch or central retinal vein occlusion.
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