Regulatory Focus™ > News Articles > NICE Changes Its Mind on New Diabetes Drug

NICE Changes Its Mind on New Diabetes Drug

Posted 31 May 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal determination reversing its January 2013 recommendation against the reimbursement of an innovative new type 2 diabetes drug, Forxiga, and now recommends its use as an add-on combination with the blood-sugar-lowering drug metformin, and in combination with insulin.

Forxiga is a first-in-class drug that works by blocking the re-absorption of glucose in the kidneys and promoting excretion of excess glucose in the urine. It's designed to complement the metformin-plus-insulin treatment combination commonly used by type 2 diabetics.

"We are pleased to recommend dapagliflozin for some people with type 2 diabetes," Carole Longson, health technology evaluation chief at NICE, said in a statement. "It is a serious problem in the UK, and dapagliflozin provides another treatment option for some people with this condition."

Around 2.9 million people in the UK are living with diabetes, nearly half of whom are uncontrolled on their current treatment regimens, and a further 850,000 people have type 2 diabetes but are unaware that they have the condition, according to NICE. More than 80% of people with type 2 diabetes are overweight, and researchers have coined a new term-"diabesity"-to acknowledge that these two conditions often co-exist. Weight gain adds to the burden of patients with type 2 diabetes and increases the risk of cardiovascular disease.

The positive recommendation for Forxiga was issued despite the fact that Bristol-Myers Squibb and Astra Zeneca did not submit a so-called "patient access scheme", which is a specific discount agreement for the National Health Service (NHS).  NICE expects that final guidance will be published in June of this year. The decision is already being seen by some as an important victory for the new drug, which is approved in the EU but not yet in the US. The FDA declined to approve Forxiga last year out of concern for cardiac safety.


NICE Final Appraisal on Forxiga

Read all Breaking News from RegLinks

Tags: UK

Regulatory Focus newsletters

All the biggest regulatory news and happenings.