Reason for request
Extension of indication
Clinical Benefit
| Moderate |
- In combination with insulin alone: insufficient
- In combination with insulin and metformin: moderate
|
| Insufficient |
|
Clinical Added Value
| no clinical added value |
Not applicable. In the absence of direct comparative data versus an active comparator, the Transparency Committee considers that GALVUS/JALRA does not provide any improvement in actual benefit (level V, non-existent) in the treatment of patients with type 2 diabetes in combination with insulin and metformin, in patients not achieving or maintaining the glycaemic targets on a combination of insulin + metformin.
|
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