Exenatide, powder for injection, 2 mg, Bydureon

1. Purpose of Application
The major re-submission requested listing of a 2 mg once weekly formulation for the treatment of Type 2 diabetes as:Exenatide acetate powder,Exenatide powder

1) Dual combination therapy with metformin or a sulfonylurea in a patient who meets certain criteria; and

2) Triple combination therapy with metformin and a sulfonylurea in a patient who meets certain criteria.

2. Background
This was the third consideration by the PBAC of the once weekly formulation. Exenatide 5 mcg and 10 mcg (twice daily) have been PBS listed since 1 August 2010.

The Public Summary Document for a submission rejected by the PBAC in July 2011 is available on the PBS website.

At the July 2013 meeting, the PBAC rejected a minor submission for exenatide once weekly injection on the basis of no new data presented to support the claims of comparative effectiveness and safety and unclear cost-offsets.

3. Registration Status
Exenatide 2 mg powder for injection was registered by the TGA on 20 December 2012 for:

The treatment of type 2 diabetes mellitus in combination with metformin; or sulfonylureas; or metformin and a sulfonylurea in patients who have not achieved adequate glycaemic control.
4. Listing Requested and PBAC’s View
The requested listing was unchanged from the previous submission:

Authority required (STREAMLINED)

Dual combination therapy with metformin or a sulfonylurea.

Type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 despite treatment with either metformin or a sulfonylurea and where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.

Triple combination therapy with metformin and a sulfonylurea.

Type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 despite treatment with maximally tolerated doses of metformin and a sulfonylurea