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Briefing Note: dapagliflozin (Forxiga)

SMC accepted dapagliflozin for restricted use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when used 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.

Diabetes mellitus is a condition in which there is too much sugar present in the blood. Type 2 diabetes develops when the body does not make enough insulin (a hormone which helps sugar to be used by the body) or the insulin that is produced does not work properly. Keeping blood sugar levels as near to normal as possible reduces the risk of long-term diabetes complications such as heart disease, blindness, stroke and kidney failure.

Dapagliflozin is a new medicine that blocks a salt-sugar transporter in the kidney and removes excess blood sugar in the urine. It is taken as a tablet once daily in combination with other glucose-lowering medicinal products that include insulin, when used as add-on therapy.

Dapagliflozin has a licence for use in adults with type 2 diabetes mellitus to improve glycaemic control (i) as monotherapy (when diet and exercise do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance) and (ii) as add-on combination therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The submitting companies have requested that SMC considers dapagliflozin when positioned for use: as dual therapy in combination with metformin, when metformin alone with diet and exercise does not
provide adequate glycaemic control, or in addition to insulin, alone or with other oral anti-diabetic medicines, when the underlying treatment regimen, which includes insulin, does not provide adequate glycaemic control.

The results of three studies showed that dapagliflozin when added to metformin was as good as a sulphonylurea in combination with metformin, and better than placebo (a dummy medicine containing no active treatment) in terms of glycaemic control, as measured by change in HbA1c. This was also accompanied by reductions in body weight. The risk of hypoglycaemia (low blood sugar) with dapagliflozin was similar to placebo and lower, when compared with a sulphonylurea. In addition, a study showed that dapagligflozin, when added to an insulincontaining regimen, was associated with greater reductions in HbA1c and in body weight; and similar rates of hypoglycaemia when compared with placebo.

SMC accepted dapagliflozin for restricted use because the economic case was considered to have been demonstrated for the metformin add-on analysis compared with treatment with thiazolidinediones or DPP-4 inhibitors but not compared with sulphonylureas. Weaknesses in the economic case for dapagliflozin as an addition to insulin-containing regimens in patients who have inadequate glycaemic control meant that SMC was unable to accept dapagliflozin for this patient group.

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 company’s submission related only to the use of dapagliflozin when used as dual therapy in combination with either metformin or insulin. Therefore, SMC cannot recommend the use of dapagliflozin as monotherapy.