PBAC's latest decision on Saxagliptin with metformin: Deferred (2013). Considered for Type 2 diabetes mellitus in patients whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, thiazolidinedione or glucagon-like peptide-1 despite treatment with metformin, where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2013
Submissions
2
2013 → 2013
Eligible population
Adults with type 2 diabetes mellitus whose HbA1c is greater than 7% despite treatment with metformin alone, where sulfonylurea combination therapy is contraindicated or not tolerated, and requiring initiation of a DPP-4 inhibitor, thiazolidinedione, or GLP-1 agonist.
Therapy area
Endocrinology
Line of therapy
Third-line
Evidence base
RCT
Primary endpoint
HbA1c reduction
Pivotal trial size
160 patients
Key trials
Study 081, Study 092, Study 120, Study 152, Study 080
Comparator
saxagliptin 5 mg once daily and metformin (500 mg, 850 mg, or 1000 mg) as individual components
Economic model
Cost-minimisation
Eligible patients/year
10,000
ICER note
Cost-minimisation analysis presented; no ICER calculated as submission claimed bioequivalence to individual components.