canagliflozin (Invokana®)

following a full submission:

canagliflozin (Invokana®) is accepted for restricted use within NHS Scotland.

Indication under review: In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on therapy 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
• triple therapy in combination with metformin plus standard of care
• add-on to insulin therapy in combination with insulin plus standard of care

Treatment with canagliflozin reduces glycosylated haemoglobin (HbA1c) significantly more than placebo when used in combination with various anti-hyperglycaemic regimens (metformin, metformin and sulfonylurea, metformin and pioglitazone, insulin with/without additional anti-hyperglycaemic agents). In addition to metformin, canagliflozin was non-inferior to a sulfonylurea and a dipeptidyl peptidase-4 (DPP-4) inhibitor. In combination with metformin and sulfonylurea, canagliflozin was non-inferior to a DPP-4 inhibitor.  Canagliflozin is also associated with reductions in body weight and systolic blood pressure.

Canagliflozin is also licensed for use as monotherapy.  The manufacturer’s submission related only to the use of canagliflozin as add-on therapy with other glucose-lowering medicinal products.  SMC cannot recommend the use of canagliflozin as monotherapy.