Draft guidance published on dapagliflozin with insulin for treating type 1 diabetes.

NICE has published a final draft guidance recommending that Dapagliflozin (Forxiga, AstraZeneca) with insulin could be considered a treatment option for people with type 1 diabetes when insulin alone does not provide good blood glucose levels control.

It is estimated that around 90,000 people could be eligible for treatment with dapagliflozin (Forxiga, AstraZeneca).

The guidelines recommended the treatment should be considered as an option for adults with type 1 diabetes with a body mass index (BMI) of at least 27 kg/m2.

Around 8% of people with diabetes in the UK have type 1 diabetes - caused when the level of glucose (sugar) in the person’s blood is too high because their body cannot produce enough insulin. Daily injections of insulin are needed to keep a person’s blood glucose levels under control.

In addition to insulin dose and weight, certain conditions must be met for the treatment to be considered suitable in the NICE guidelines, including completion of a structured education programme on complications of diabetes, including diabetic ketoacidosis.

It is recommended that treatment with dapagliflozin should be stopped if blood glucose control does not improve because of the increased risk of diabetic ketoacidosis.

Dapagliflozin is taken as a once-a-day tablet and is considered an innovative medicine which can help fill an unmet need for people with inadequately controlled type 1 diabetes despite optimised insulin therapy.

Dapagliflozin with insulin is considered to have only modest benefits based on the evidence from clinical trials. These showed small improvements in blood glucose levels and weight loss, and very small improvements in quality of life.

NICE’s independent appraisal committee however highlighted an unmet need for interventions that help people to reach 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.

If there are no appeals, NICE will publish final guidance to the NHS in August.

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