Dapagliflozin with insulin is recommended by NICE as an option for treating type I diabetes in adults with a BMI of at least 27kg/m2, when optimal insulin therapy alone does not provide adequate glycaemic control.
To be eligible for treatment with the SGLT2 inhibitor, patients must be receiving insulin doses of more than 0.5 units/kg per day and have completed a structured education programme that is quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as:
- how to recognise risk factors, signs and symptoms
- how and when to monitor blood ketone levels
- what actions to take for elevated blood ketones
They must also have their treatment with dapagliflozin started and supervised by a consultant physician specialising in endocrinology and diabetes.
HbA1c levels should be assessed after 6 months and regularly thereafter. Because of the increased risk of diabetic ketoacidosis, dapagliflozin should be stopped if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%).
NICE considered the benefits of dapagliflozin with insulin to be modest, based on clinical trials showing small improvements in HbA1c levels and weight loss, and very small improvements in quality of life. However, the appraisal committee recognised the unmet need for interventions that help people with type I diabetes achieve good glycaemic control without complications.
The cost-effectiveness estimate for dapagliflozin plus insulin compared with insulin alone is within the range that NICE normally considers an acceptable use of NHS resources.
It is estimated that around 90,000 people could be eligible for treatment with dapagliflozin.