PBAC's latest decision on Vildagliptin/metformin: Not recommended (2013). Considered for Type 2 diabetes mellitus as triple oral combination therapy (vildagliptin/metformin fixed-dose combination with a sulfonylurea) in patients with HbA1c greater than 7% despite treatment with maximally tolerated doses of metformin and a sulfonylurea.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
patients with type 2 diabetes mellitus whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, thiazolidinedione or glucagon-like peptide-1 despite treatment with maximally tolerated doses of metformin and a sulfonylurea
Therapy area
Endocrinology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
Surrogate
Pivotal trial size
128 patients
Key trials
LMF2303, LMF2307, LMF2301
Comparator
free combination of vildagliptin and metformin (primary); pioglitazone in triple therapy (secondary, rejected by PBAC)
Economic model
Cost-minimisation
ICER note
cost-minimisation analysis presented but not accepted by PBAC due to lack of efficacy/safety evidence for FDC in triple therapy
Why PBAC said no
Reasons cited in the latest PSD: cost-minimisation analysis contingent on bioequivalence as surrogate for efficacy/safety in triple therapy with no direct evidence presented; no evidence of efficacy/safety of vildagliptin/metformin FDC in triple therapy; pioglitazone rejected as comparator; indirect comparisons for vildagliptin in triple therapy considered unreliable