Final NICE Approval for Eli Lilly’s Bydureon

The UK’s National Institute for Health and Clinical Excellence (NICE) announced yesterday that they had confirmed in final guidance a endorsement of the use of Eli Lilly’s Bydureon (prolonged-release exenatide) in triple-therapy regimens as a treatment option for people with type 2 diabetes.

The director of NICE’s centre for health technology evaluation, Professor Carole Longson, noted that type 2 diabetes is gradually becoming more common in the UK, and now affects 2.25 million individuals.

“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 commented.

Bydureon’s use on the NHS is recommended when control of blood glucose remains or becomes insufficient, 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 treatment with insulin would have substantial occupational consequences, or weight loss would assist other significant obesity-related comorbidities.

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

They also recommend the drug’s use in dual-therapy options (in combination with metformin or a sulphonylurea) as a therapy 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.

As before, Bydureon’s use in a dually-therapy regime should only be continued if an advantageous metabolic response has been shown, according to the recommendation from the National Institute for Health and Clinical Excellence.

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 attained adequate glycaemic control on maximally-tolerated doses of those oral therapies.  The advisory dose is 2mg once weekly by subcutaneous injection.

The treatment will cost £73.76 for a pack of four single-dose kits containing one vial of exenatide 2mg powder and a pre-filled syringe.  However, NICE notes that real costs may differ in different settings because of negotiated procurement discounts.


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