empagliflozin (Jardiance)

following a full submission:

empagliflozin (Jardiance®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of type 2 diabetes to improve glycaemic control in adults as add-on combination therapy: in combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

SMC restriction: to use in the following situations:
• dual therapy in combination with metformin, when a sulphonylurea is inappropriate
• triple therapy in combination with metformin plus standard of care
• add-on to insulin therapy in combination with insulin plus standard of care

Empagliflozin was superior to placebo for glycaemic control in combination with various anti-diabetic medicines (metformin; metformin plus sulphonylurea; thiazolidinedione ± metformin; and insulin) and it was non-inferior to a sulphonylurea in combination with metformin.

Empagliflozin is also indicated as monotherapy in patients who cannot tolerate metformin. SMC cannot recommend the use of empagliflozin as monotherapy as the company’s submission did not include evidence of cost-effectiveness in this setting.