In its draft guidance published last week, the National Institute of Clinical Excellence (NICE) said it will not recommend Forxiga (dapagliflozin) for approval and is requesting "further clarification and information" from the manufacturers ahead of the second appraisal committee meeting next month.
The main concern raised by NICE was the use of network meta-analyses to determine the clinical effectiveness of Forxiga, which according to the committee meant there was a "significant uncertainty about the validity of the results".
Professor Carole Longson, Health Technology Evaluation Centre director at NICE said in a statement, "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."
Forxiga received marketing authorisation from the European Medicines Agency in November, after the regulator said the medicine’s benefits outweighed the risks of infection and some types of cancer.
Bristol Myers-Squibb vice president and general manager for UK and Ireland operations Amadou Diarra said the companies are "disappointed with the outcome" but said they were "committed to working with NICE to provide additional information and analysis on the cost-effectiveness model."
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