NICE is minded not to recommend Bristol-Myers Squibb and AstraZeneca’s Forxiga for type II diabetes.

The Institute said in its first round of draft guidance that it is requesting “further clarification and information” from both manufacturers ahead of the second appraisal committee meeting, which is scheduled for April. 

Forxiga (dapagliflozin) works by blocking the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine. It was approved in Europe last November and is licensed as a first-in-class treatment for adults with type II diabetes to improve glycaemic control as: a monotherapy when diet and exercise do not help sugar levels in patients who can’t use metformin.

It can also be used as an add-on combination therapy with other glucose-lowering agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control - the subject of NICE’s appraisal is the add-on combination therapy indication.

In considering the evidence on the clinical effectiveness of Forxiga as add-on therapy to insulin, NICE’s Committee noted that the evidence came from two placebo-controlled clinical trials, one of which was of short duration (only 12 weeks), and an additional network meta-analysis.

The clinical effectiveness of the drug compared with other active treatments that might be added on to insulin was based on the manufacturers’ network meta-analyses, and the Committee concluded there was “significant uncertainty” about the validity of the results.

When looking at the drug as an add-on to metformin, the Committee noted that the evidence came from three clinical trials and a network meta-analysis. Only one of these clinical trials of Forxiga had an active comparator (sulfonylurea) and the clinical effectiveness of BMS and AZ’s drug, compared with established treatments such as DPP-4 inhibitors, thiazolidinediones and GLP-1 analogues, was based solely on network meta-analysis.

The Committee concluded that there was also “significant uncertainty about the validity of the results of the network meta-analyses”, and have requested that the manufacturers provide a revised analysis and to submit the programme code along with the trial data used for each analysis.

Professor Carole Longson, health technology evaluation centre director at NICE, said: NICE said: “Type II diabetes is a serious problem in the UK and it is important that there is a range of different treatment options available. Unfortunately the Appraisal Committee is currently unable to recommend dapagliflozin, one of the options, for the treatment of this condition. They have requested further information from the manufacturer, which will be considered at the next Appraisal Committee meeting in April.” Final guidance is likely to be published in June this year.