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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
bzjS4SCLkg8yK41Z