UK-based pharmaceutical company Bristol-Myers Squibb and AstraZeneca have announced that the National Institute for Health and Clinical Excellence (NICE) in the UK has issued an Appraisal Consultation Document (ACD) for its first-in-class, Type 2 diabetes medicine FORXIGA (dapagliflozin).
As part of the appraisal, NICE has issued a 'Minded Not to Recommend' and requested for the further information and analysis on the submitted cost-effectiveness model.
Used as the first-in-class oral once daily treatment, Dapagliflozin was created as an alternative medicine for patients suffering with Type 2 diabetes, who are failing with their diet, exercise plan and existing medication.
The therapy has been looked as a comprehensive clinical development program for adults with Type 2 diabetes, which effectively lowers HbA1c and maintains glycaemic control, apart from the additional secondary benefit of weight loss sustained for two years.
Bristol Myers-Squibb VP and general manager for UK and Ireland operations Amadou Diarra said the firms are disappointed with the outcome as they have already submitted required information, which included an externally-validated cost-effectiveness model, to the NICE .
"During the public Appraisal Committee meeting it was discussed that dapagliflozin will provide a further treatment option for Type 2 diabetes and we are committed to working with NICE to provide additional information and analysis on the cost-effectiveness model and will do everything we can to drive national access for this alternative treatment for Type 2 diabetes, which is a progressive and serious condition that impacts an estimated 2.6 million people in the UK," Diarra added.
