2 Information about sotagliflozin

2 Information about sotagliflozin

Marketing authorisation indication

Sotagliflozin is indicated 'as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a body mass index (BMI) 27 kg/m2 or more, who have failed to achieve adequate glycaemic control despite optimal insulin therapy'.

Sotagliflozin should not be started in people with type 1 diabetes with a low insulin need. It should not be started in people with a glomerular filtration rate of less than 60 ml/min and should be stopped at a glomerular filtration rate persistently below 45 ml/min. Sotagliflozin should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. During treatment with sotagliflozin, insulin therapy should be continuously optimised to prevent ketosis and diabetic ketoacidosis, and the insulin dose should only be reduced to avoid hypoglycaemia.

Dosage in the marketing authorisation

Administered orally as a 200 mg tablet once daily before the first meal of the day. After at least 3 months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily.

Price

The list price of sotagliflozin is £39.20 for 30×200 mg tablets (company submission document B). The treatment cost at list price is £477.30 per year. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)