The National Institute for Health and Clinical Excellence (NICE) has confirmed in final guidance that it recommends the use of Eli Lilly's Bydureon (prolonged-release exenatide) in triple-therapy regimens as a treatment option for people with type 2 diabetes.

Bydureon's use on the NHS is recommended, it says, when control of blood glucose remains or becomes inadequate, and the person has: - a body mass index (BMI) of 35 kg/m2 or higher in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight), or - a BMI below 35 kg/m2, and therapy with insulin would have significant occupational implications, or weight loss would benefit other significant obesity-related comorbidities.

Treatment with Bydureon in a triple-therapy regimen should only be continued if a beneficial metabolic response has been shown, says NICE.

It also recommends the drug's use in dual-therapy options (in combination with metformin or a sulphonylurea) as a treatment option in people with type 2 diabetes only if: - the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated; and - the person is intolerant of thiazolidinediones and dipeptidyl/peptidase-4 (DPP-4)  inhibitors, or treatment with thiazolidinediones and DP-4 inhibitors is contraindicated.

Again, Bydureon's use in a dually-therapy regime should only be continued if a beneficial metabolic response has been shown, says NICE.

Announcing the final guidance, Professor Carole Longson, director of NICE's centre for health technology evaluation, pointed out that type 2 diabetes is increasingly more common in the UK, and now affects 2.25 million people.

"It is a serious, progressive disease, so we are very pleased to be able to recommend prolonged-release exenatide as both a clinical and cost-effective option," she said. 

- Bydureon has a UK marketing authorisation for the treatment of type 2 diabetes mellitus in adults to achieve glycaemic control in combination with: - metformin; - a sulphonylurea; - a thiazolidinedione; - metformin and a sulphonylurea; - metformin and a thiazolidinedione - in adults who have not achieved adequate glycaemic control on maximally-tolerated doses of those oral therapies. The recommended dose is 2mg once weekly by subcutaneous injection.

The drug costs £73.76 for a pack of four single-dose kits containing one vial of exenatide 2mg powder and a pre-filled syringe. NICE notes that actual costs may vary in different settings because of negotiated procurement discounts.