The National Institute for Health and Clinical Excellence (NICE) has reported that it is unable to approve Dapagliflozin (Forxiga) for diabetes wellness, even though the drug has already been approved by the Scottish Medicines Consortium in January as an add-on therapy with metformin.
The drug was launched in the UK late last year, but NICE does not feel able to recommend it in combination with insulin because there is ‘significant uncertainty’ about the results that manufacturers Bristol-Myers Squibb and AstraZeneca presented. NICE has agreed to another meeting about the drug in April, but in the meantime has asked the companies for further information on cost-effectiveness, which they have consented to.
Dapagliflozin is a new type of diabetes treatment class called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which improve for your wellbeing when you have diabetes by reducing the amount of glucose that your kidney reabsorbs and increasing the amount of glucose that your urine excretes. The oral, once-daily drug has been shown to reduce blood glucose to a similar extent as sulphoylurea plus metformin, and it has the added wellness benefit of encouraging weight loss.
According to Amadou Diarra, vice president and general manager UK and Ireland at Bristol Myers-Squibb, ‘Bristol-Myers Squibb and AstraZeneca are disappointed with the outcome today, particularly given the alliance responded in full to the questions raised prior to the appraisal committee meeting. We submitted a robust dossier of information, which included an externally-validated cost-effectiveness model.’
Professor Carole Longson, director of NICE’s health technology evaluation centre, stated, ‘Type 2 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.’
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