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Final NICE "yes" for Bydureon

UK News | February 23, 2012

Lynne Taylor

Final NICE "yes" for Bydureon

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.

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