exenatide (Bydureon)

following a full submission

exenatide once weekly (Bydureon®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of type 2 diabetes mellitus in combination with:
• metformin
• sulphonylurea
• thiazolidinedione
• metformin and sulphonylurea 
• metformin and thiazolidinedione
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

SMC restriction: Exenatide once weekly is restricted to use as a third line treatment option.  The economic case for exenatide once weekly for second line use in combination with metformin in place of a sulphonylurea has not been made. 

In four randomised comparative studies in patients with type II diabetes and receiving oral anti-diabetic agents and/or diet and exercise regimens, exenatide once weekly was superior to the comparators for change in HbA1c.  However in a fifth study exenatide once weekly was not superior to another glucagon-like peptide-1 receptor agonist.