Bristol-Myers Squibb and AstraZeneca have been asked for further clarification and information after concerns were raised about trial data and the cost modelling of the drug.
Forxiga has a UK marketing authorisation in adults with type 2 diabetes mellitus. It’s used as monotherapy when diet and exercise alone do not provide adequate control and as an add-on combination therapy with other treatments, such as insulin and metformin.
During the appraisal, NICE’s independent Appraisal Committee questioned the evidence on the clinical effectiveness of Forxiga as an add-on to insulin and metformin.
The Committee noted that the trial data for the drug as an add-on therapy to insulin came from two placebo-controlled trials – one of which was only 12 weeks in duration. The evidence supplied for Forxiga as an add-on to metformin came from three clinical trials and a network meta-analysis.
Concerns were also raised by the Committee surrounding the comparisons made by BMS and AZ of the cost of Forxiga and with that of other anti-diabetic drug therapies and how these were initially made.
“Type 2 diabetes is a serious problem in the UK and it is important that there is a range of different treatment options available,” said Professor Carole Longson, Health Technology Evaluation Centre Director at NICE. “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 expected in June 2013.