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FORXIGA

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Opinions on drugs - Posted on May 09 2014

Reason for request

Inclusion

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Clinical Benefit

Moderate

The actual benefit of FORXIGA is :

- moderate as dual therapy in combination with metformin or a sulfonylurea

- moderate as triple therapy in combination with insulin and metformin

Insufficient

- insufficient as monotherapy for reimbursement by National Health Insurance


Clinical Added Value

no clinical added value

In the dual therapy indications, in combination with metformin or a sulfonylurea and triple therapy, in combination with insulin and metformin :
Given the very modest glycaemic control observed compared with the placebo, doubts about the safety profile, particularly on an infectious, cardiovascular and carcinogenic level, and the difficulty in defining the therapeutic use, the Committee cannot recognise any improvement for FORXIGA.
In addition, the Transparency Committee considers that FORXIGA does not provide any improvement in actual benefit (level V, non-existent) in the management of patients with type 2 diabetes in dual oral therapy, in combination with metformin or a sulfonylurea and in triple therapy, in combination with insulin and metformin.

Not applicable

In the monotherapy and dual therapy indications, in combination with insulin : not applicable