NICE issues final draft guidance for Bydureon

In triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione), prolonged release exenatide is recommended as a treatment option for people with type 2 diabetes, when control of blood glucose remains or becomes inadequate (i.e. HbA_1c ≥7.5%, or other higher level agreed with the individual), and the person has: 

• A body mass index (BMI) ≥35 kg/m² 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 <35 kg/m², and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Treatment with prolonged-release exenatide in a triple therapy regimen should only be continued if a beneficial metabolic response has been shown, defined as a reduction of at least 1 percentage point in HbA_1c and a weight loss of at least 3% of initial body weight at 6 months.

Prolonged-release exenatide in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended 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 DPP-4 inhibitors is contraindicated.

Treatment with prolonged-release exenatide in a dual therapy regimen should only be continued if a beneficial metabolic response has been shown.

Exenatide prolonged release suspension is injected once weekly, as opposed to twice a day for the conventional formulation.

Final guidance is expected to be published in February 2012.

Reference
NICE (2012) Diabetes (type 2) – exenatide (prolonged release): final appraisal determination. Available at: http://www.nice.org.uk/guidance/index.jsp?action=folder&o=57832 (accessed 07.02.2012)