dapagliflozin (Forxiga)

following a resubmission:

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 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: In combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.

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

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 companies’ submission related only to the use of dapagliflozin when used in combination with insulin.  SMC cannot recommend the use of dapagliflozin as monotherapy.  SMC has previously accepted dapagliflozin for restricted use in combination with metformin.