Pioglitazone HydrochlorideACTAZE
Recommended EndocrinologyAuthority RequiredSecond-line line
Type 2 diabetes mellitus in combination with metformin and a sulfonylurea in patients with HbA1c greater than 7% despite maximally tolerated doses of metformin and a sulfonylurea.
2
Submissions
2007–07
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Sep 2001 Recommended Oral anti-diabetic drug no PSD
Access path
- TGA registered · ACTAZE
TGA label narrower than the PBS population
- Nov 2007Recommended · restricted
Evidence: RCT → Meta-analysis
- Nov 2007Recommended · restricted
Evidence: RCT → Meta-analysis
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The PBAC accepted the submission's claim of non-inferiority compared with rosiglitazone in effecting change in HbA1c with a non-inferiority threshold of 0.4%, but considered the comparative toxicity and safety of the two drugs remained unclear. PBAC · 2007
Cost-effectiveness accepted
Decision context
PopulationType 2 diabetes mellitus patients with HbA1c greater than 7% despite maximally tolerated doses of metformin and a sulfonylurea, treated with pioglitazone in triple oral combination therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | rosiglitazone | — | RCT · Efficacy measures (HbA1c, FPG) |
| Nov 2007 | Recommended · restricted | rosiglitazone | — | Meta-analysis · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to triple therapy after failure of dual metformin-sulfonylurea at maximum tolerated doses with HbA1c >7%.