PBAC's latest decision on Metformin and saxagliptin: Recommended with restriction (2013). Considered for Treatment of type 2 diabetes mellitus in patients with HbA1c greater than 7% despite treatment with metformin, where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
Adults with type 2 diabetes mellitus whose HbA1c is greater than 7% despite treatment with metformin and who are unable to use metformin in combination with a sulfonylurea due to contraindication or intolerance.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
HbA1c
Pivotal trial size
16,492 patients
Key trials
Study 111, Study 112, Study 004, Trial 086
Comparator
metformin XR and saxagliptin as individual components; other metformin/gliptin fixed-dose combinations
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. PBAC considered cost-effectiveness acceptable if cost-minimised against alogliptin/metformin FDC.