PBAC's latest decision on Linagliptin with metformin hydrochloride: Deferred (2013). Considered for 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, prior to initiation of a dipeptidyl peptidase-4 inhibitor, thiazolidinedione, or glucagon-like peptide-1 agonist.
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 metformin plus sulfonylurea is contraindicated or not tolerated.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
HbA1c reduction
Key trials
1218.47, 1288.2, 1288.3, 1288.1, 1218.46
Comparator
linagliptin and metformin constituent tablets
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated as submission claimed bioequivalence to constituent tablets.