Reason for request

Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use in the extension of indication “treatment in adults of reduced visual acuity due to diabetic macular oedema”.

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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.

 


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.


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