Reason for request

Extension of indication

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Clinical Benefit

Substantial

The actual benefit of EUCREAS/ICANDRA is substantial in the extension of the Marketing Authorisation indication "in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea".


Clinical Added Value

no clinical added value

The Transparency Committee considers that EUCREAS/ICANDRA does not provide any improvement in actual benefit (level V, non-existent) in the treatment of patients with type 2 diabetes in oral triple therapy in combination with a sulfonylurea.


Therapeutic use

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