Reason for request
Inclusion
No clinical benefit demonstrated in dual therapy with metformin or in triple therapy with metformin/sulfonylurea or metformin/insulin in the management of type 2 diabetic patients inadequately controlled with metformin, or with a combination of metformin and a sulfonylurea or metformin and insulin
No clinical benefit in monotherapy or in dual therapy with a sulfonylurea or insulin
- JARDIANCE has Marketing Authorisation in the treatment of type 2 diabetes in monotherapy and in combination with other blood glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
- The available clinical data are based mainly on studies versus placebo, whereas active comparators do exist. Just one study has shown modest efficacy for JARDIANCE 25 mg/day versus glimepiride (sulfonylurea) 1-4 mg/day whereas its maximum dose is 6 mg/day.
Clinical Benefit
| Moderate |
Monotherapy : Insufficient for reimbursement by National Health Insurance
Dual therapy :
- with metformin : Moderate
Tritherapy :
- with metformin and a sulfonylurea : Moderate
- with insulin and metformin : Moderate |
| Insufficient |
- with a sulfonylurea : Insufficient for reimbursement by National Health Insurance
- with insulin : Insufficient for reimbursement by National Health Insurance |
Clinical Added Value
| no clinical added value |
In the indications as dual therapy with metformin, and as tritherapy with metformin and a sulfonylurea or with metformin and insulin :
In light of the available clinical data, namely placebo-controlled studies with empagliflozin 10 or 25 mg/day when active comparators are available and modest
results from a sequential non-inferiority and superiority study of empagliflozin at its maximum dose of 25 mg/day versus an active comparator, the sulfonylurea glimepiride, at doses of 1 to 4 mg/day (whereas its maximum dose is 6 mg/day), the Committee considers that the JARDIANCE proprietary medicinal products do not provide any improvement in actual benefit (level V, non-existent) in the management of patients with poorly controlled type 2 diabetes, as dual oral therapy in combination with metformin and as tritherapy in combination with metformin and a sulfonylurea or with metformin and insulin.
In the indications as monotherapy, and as dual therapy with sulfonylureas or insulin : Not applicable. |
| Not applicable |
|
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