2 The technology
2.1 Dapagliflozin (Forxiga, Bristol‑Myers Squibb and AstraZeneca) is a sodium–glucose cotransporter‑2 (SGLT‑2) inhibitor that blocks the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine. It has a UK marketing authorisation 'in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control 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
add-on combination therapy with other glucose-lowering agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control'.
The subject of this appraisal is the add-on therapy indication.
2.2 The summary of product characteristics lists the following adverse reactions for dapagliflozin: hypoglycaemia (when used with a sulfonylurea or insulin), urinary tract and genital infection, back pain, dysuria, polyuria, dyslipidaemia and elevated haematocrit. Dapagliflozin is not recommended for use in people with moderate to severe renal impairment (patients with a creatinine clearance rate of less than 60 ml/min or an estimated glomerular filtration rate of less than 60 ml/min/1.73 m2) because its efficacy is dependent on renal function. Dapagliflozin is also not recommended for use in combination with pioglitazone. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The list price of dapagliflozin is £36.59 for 28 5‑mg or 10‑mg tablets (excluding VAT; 'British national formulary' [BNF] edition 64). Dapagliflozin is administered orally as a single dose of 10 mg per day. Costs may vary in different settings because of negotiated procurement discounts.