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New HTA Decisions in England
August 2019
Drug name
FORXIGA® (dapagliflozin)
Company
AstraZeneca
Decision date
12/07/2019
Therapeutic area
Diabetes and other endocrinal, nutritional and metabolic conditions
Therapeutic sub area
Diabetes
Decision
Recommended with restrictions
Indication
Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy
Decision Detail
1) they are on insulin doses of more than 0.5 units/kg of body weight/day and they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as: - how to recognise its risk factors, signs and symptoms - how and when to monitor blood ketone levels - what actions to take for elevated blood ketones 2) treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes.
Summary
The key clinical evidence for dapagliflozin came from 2 randomised, double-blind trials, DEPICT‑1 and DEPICT-2, comparing dapagliflozin plus insulin therapy at 2 doses (5 mg [licensed] or 10 mg [unlicensed]) with placebo plus insulin therapy over 52 weeks. Evidence from the clinical trials shows small improvements in blood glucose (HbA1c levels) and weight loss, and very small improvements in quality of life, when dapagliflozin plus insulin is compared with placebo plus insulin in adults with type 1 diabetes and inadequate blood glucose control despite optimised insulin therapy. In the company's scenario that assumes no benefit from improved HbA1c levels beyond the trial period (1 year), 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. Dapagliflozin with insulin is therefore recommended as an option for type 1 diabetes in adults. Because of the increased risk of diabetic ketoacidosis, dapagliflozin should be stopped if blood glucose control does not improve.