dapagliflozin (Forxiga)

following a full submission:

dapagliflozin (Forxiga) is accepted for restricted use within NHSScotland.

Indication under review: For use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control 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: Dapagliflozin is restricted to use as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.

In three phase III randomised, controlled studies, dapagliflozin when added to metformin was non-inferior to a sulphonylurea in combination with metformin, and superior to placebo in terms of glycaemic control, as measured by change in HbA1c. This was accompanied by reductions in body weight and the risk of hypoglycaemia with dapagliflozin treatment was similar to placebo and lower, when compared with sulphonylurea.

In a phase III randomised, controlled study, dapagliflozin treatment, when added to an insulin-containing regimen, was associated with; greater reductions in HbA1c, in body weight; and similar rates of hypoglycaemia when compared with placebo.

The submitting companies did not present a sufficiently robust economic analysis to gain acceptance by SMC for use in addition to insulin in patients who have inadequate glycaemic control.

Dapagliflozin is also licensed for use as monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. The manufacturers’ submission related only to the use of dapagliflozin when used as dual therapy in combination with either metformin or insulin. SMC cannot recommend the use of dapagliflozin as monotherapy.