Vildagliptin/MetforminARX-VILDAGLIPTIN/METFORMIN
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.
Decisions on record
- Meeting Jul 2013 Not recommended Type 2 diabetes
- Meeting Nov 2010 Recommended Type 2 diabetes no PSD
Access path
- TGA registered · ARX-VILDAGLIPTIN/METFORMIN
TGA label narrower than the PBS population
- Jul 2013Recommended
vs free combination of vildagliptin and metformin (primary)…
- PBS listing · Authority Required
Cost-effectiveness
cost-minimisation analysis presented but not accepted by PBAC due to lack of efficacy/safety evidence for FDC in triple therapy
The PBAC noted that the cost-minimisation analysis was dependent on the acceptance of bioequivalence as a surrogate for efficacy/safety in triple therapy, and that the effectiveness of vildagliptin in triple therapy would apply to the FDC. PBAC · 2013
Decision context
Populationpatients 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
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | free combination of vildagliptin and metformin (primary); pioglitazone in triple therapy (secondary, rejected by PBAC) | — | Single-arm · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to triple therapy with HbA1c >7% despite maximal metformin and sulfonylurea; TGA label permits use when inadequately controlled without HbA1c threshold specification.