Reason for request
Inclusion
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
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Insufficient |
- insufficient as monotherapy for reimbursement by National Health Insurance
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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.
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Not applicable |
In the monotherapy and dual therapy indications, in combination with insulin : not applicable
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