Reason for request
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Clinical Benefit
Insufficient |
It is insufficient in the other cases. |
Substantial |
The actual benefit provided by LUCENTIS 10 mg/ml, solution for injection, is important in patients with visual impairment less or equal to 5/10 due to diabetic macular oedema in cases of diffuse type or leaks close to the centre of the macula and where diabetes management has been optimised.
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Clinical Added Value
minor |
Since there are no data on the long-term maintenance of the efficacy of LUCENTIS 10 mg/ml, solution for injection, in monotherapy on visual acuity, this product is regarded as providing a minor improvement in actual benefit (IAB IV) in the strategy for treatment of visual impairment due to diabetic macular oedema in with diffuse type or leaks close to the centre of the macula for patients with visual acuity less than or equal to 5/10 and in whom diabetic management has been optimised. |