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
  • As dual therapy in combination with insulin :

Not applicable.

  • As triple therapy in combination with insulin and metformin :

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.