The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s single technology appraisal process, was to review the evidence for the clinical and cost-effectiveness of Dapagliflozin in combination with other glucose-lowering therapies for treating type 2 diabetes in adults. The clinical evidence submitted by the company (Bristol-Myers Squibb and AstraZeneca) responsible for manufacturing Dapagliflozin (Forxiga) consisted of 5 RCTs: 3 in patients with type 2 diabetes inadequately controlled with metformin alone and 2 in patients with type 2 diabetes inadequately controlled with insulin with or without oral antidiabetic drugs. Of the 3 trials of Dapagliflozin as an add-on to metformin, two were placebo controlled with follow-up of 24 weeks and one compared Dapagliflozin with a sulfonylurea for up to 52 weeks of follow-up. The 2 trials of Dapagliflozin as an add-on to insulin were both placebo controlled. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.
After taking into consideration the company submission and the findings of the ERG’s critique, NICE released clinical guidance (TA288, June 2013). Dapagliflozin in a dual therapy regimen in combination with metformin was initially recommended as an option for treating type 2 diabetes, only if (i) a sulfonylurea was contraindicated or not tolerated or (ii) the person was at significant risk of hypoglycaemia or its consequences. Dapagliflozin in combination with insulin with or without other antidiabetic drugs was recommended as an option for treating type 2 diabetes.
NICE updated and replaced this guidance in November 2016 (TA418).
Miriam Brazzelli; firstname.lastname@example.org
Cummins, E, Scott, N, Rothnie, K, Waugh, N, Fraser, C, Philip, S, Brazzelli, M. Dapagliflozin for the treatment of type 2 diabetes: A Single Technology Appraisal. Evidence Review Group report in support of NICE STA programme. University of Aberdeen: Health Services Research Unit; 2013 URL: https://www.nice.org.uk/guidance/ta288/documents/diabetes-type-2-dapagliflozin-evaluation-report2