New diabetes drug to be rejected
NICE unable to recommend dapagliflozin (Forxiga) for type 2 diabetes and requests more information from the manufacturer
1st February 2013 - In draft guidance published today NICE (the National Institute for Health and Clinical Excellence) has said it is minded not to recommend dapagliflozin (Forxiga) in combination therapy for treating type 2 diabetes.
However, before it comes to a final decision, it is requesting further clarification and information from the manufacturers (Bristol-Myers Squibb and Astra Zeneca) ahead of a meeting in April.
Diabetes currently affects almost three million people in the UK around 90% of which will have type 2 diabetes - a condition that occurs when the body does not produce enough insulin or use insulin properly. Your body needs insulin to be able to use the sugar (glucose) which comes from the food you eat for energy. Without enough insulin, glucose stays in the blood, creating high levels of blood sugar.
Dapagliflozin (Forxiga) is the first in a new class of diabetes drugs. It lowers blood sugar by increasing the amount of glucose excreted in the urine. Dapagliflozin (Forxiga) is administered orally as a single dose of 10 mg per day.
This drug has, so far, been rejected by the US FDA due to concerns about a cancer risk but it has a UK marketing authorisation in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
• Monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
• 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 latest guidance from NICE was looking at the drug as an add-on combination therapy. However, it was unhappy with the information that was supplied by the manufacturers saying it was concerned about the quality and validity of some of the results. The Appraisal Committee has therefore, requested more information.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said in a press statement: "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. They have requested further information from the manufacturer, which will be considered at the next Appraisal Committee meeting in April."
Until NICE issues final guidance, likely to be published in June 2013, NHS bodies should make decisions locally on the funding of specific treatments.