The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) backing the use of Bristol-Myers Squibb (BMS)/AstraZeneca's first-in-class type 2 diabetes treatment Forxiga (dapagliflozin).

NICE is recommending the drug's use as a treatment option for adults with type 2 diabetes as dual therapy in combination with metformin, and in combination with insulin with or without other oral antidiabetic drugs. 

Currently in the UK, over one million patients are on either metformin alone or insulin, notes NICE.

The Institute's FAD recommends Forxiga to be used in combination with metformin instead of a sulphonylurea (SU) in certain patients for whom an SU is not tolerated/contraindicated or who are at significant risk of hypoglycaemia or its consequences. Also, the addition of Forxiga to metformin may be preferable to a thiazolidinedione if further weigh gain is a concern, it says.

The FAD will form the basis of final NICE guidance. It follows the marketing authorisation (MA) issued on November 14, 2012 by the European Medicines Agency (EMA) and advice from the Scottish Medicines Consortium (SMC) on January 14, 2013. 

Following a consultation on the draft recommendations in February, NICE requested further clarification and information from the manufacturers. It also asked the Decision Support Unit commissioned by the Institute to further review the economic analysis provided by the manufacturer and to perform exploratory analyses for the drug in dual therapy and as an add-on to insulin therapy.

The NICE recommendation means that adults with type 2 diabetes who are not being managed on metformin alone or insulin will soon have access to this new, cost-effective, oral, once-daily, first-in-class treatment, says the Institute.

"Type 2 diabetes is a complex and progressive disease with the potential for a wide range of complications," commented Clifford Bailey, professor of clinical science at Aston University.

"Dapagliflozin is a once-daily tablet which is a new way to control blood glucose. It also has weight-loss benefits. It works in a novel way by removing excess glucose from the body in the urine. In this way, dapagliflozin removes calories from the body," he said, and it "provides a new option for healthcare professionals and patients alike."

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, says 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.

Gwen Hall, a diabetes specialist nurse with Portsmouth Community Diabetes Service Primary Care Team, said she sees a lot of people with diabetes who are worried about managing their blood glucose levels and who struggle to maintain a healthy weight.

"Some of our current therapies can carry an increased risk of hypoglycaemia, which is an additional concern for them," she said. “What people with diabetes would like is a treatment that not only effectively controls blood glucose levels but also has the secondary benefit of weight loss and, when used in combination with metformin, has a low risk of hypoglycaemia. Dapagliflozin appears to have these benefits." 

Dapagliflozin is the first in a new class of treatments called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which work independently of insulin. Dapagliflozin works by reducing the amount of glucose reabsorbed in the kidney so, in people with type 2 diabetes, an increased amount of glucose is passed out of the body via the urine each day, along with the associated calories.

Unlike many other diabetes medications, dapagliflozin works in a novel way that is independent of insulin action. It therefore offers an alternative new approach for patients with type 2 diabetes.

NICE's recommendation was welcomed by Amadou Diarra, BMS' European vice president and general manager, UK and Ireland, who said it "marks an important milestone in providing patients with type 2 diabetes a cost-effective new treatment option."

"With the incidence of diabetes continuing to increase, it is important for patients to have a wider choice of options so that the treatment can be tailored to their individual needs," he said.

NICE expects to publish final guidance in June.