PioglitazoneACTAZE
Treatment of type 2 diabetes mellitus (T2DM). The submission requested listing of new 30-pack sizes of pioglitazone tablets (15 mg, 30 mg, and 45 mg strengths) as a replacement for the currently PBS-listed 28-pack due to supply shortages.
Decisions on record
- Meeting May 2025 Recommended Type 2 diabetes mellitus
- Meeting Nov 2007 Recommended Diabetes
Access path
- TGA registered · ACTAZE
TGA label equal than the PBS population
- May 2025Recommended
vs currently PBS-listed 28-tablet packs of Actos (pioglitazone…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended General Schedule Restricted Benefit listings of pioglitazone 15 mg, 30 mg, and 45 mg 30-pack tablets for the treatment of type 2 diabetes mellitus (T2DM).PSD · May 2025
6.2 Due to the new (larger) 30-pack across all strengths, the PBAC considered that the requested maximum quantities of 30 and 60 tablets would be appropriate for 30-day and 60-day maximum dispensed quantity (MDQ) listings, respectively.PSD · May 2025
5.5 The submission presented a cost-minimisation analysis for the new 30-pack Actos compared to the currently PBS-listed 28-pack size of the same strengths, based on an equivalent price per tablet. 5 OFFICIALPSD · May 2025
5.6 Table 2 provides a comparison of the price of pioglitazone between the different pack sizes across all strengths.PSD · May 2025
5.3 The submission noted that on 25 October 2024, the sponsor lodged a Minimum Stockholding Requirement Breach Notification to the PBS for Actos 15 mg and 30 mg tablets. The submission indicated that the current and anticipated shortages are due to limited supplies from the previous manufacturer and the relocation of manufacturing to a new site, resulting in the change to pack size from 28 to 30 tablets.PSD · May 2025
Cost-effectiveness
Cost-minimisation analysis based on equivalent price per tablet; no ICER calculated by design.
The PBAC advised that the cost-minimisation approach, based on an equivalent price per tablet, was appropriate. PBAC · 2025
Decision context
PopulationAdults with type 2 diabetes mellitus requiring treatment with pioglitazone monotherapy, dual therapy (with sulfonylureas, insulin, or metformin), or triple therapy (with sulfonylurea and metformin).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended | currently PBS-listed 28-tablet packs of Actos (pioglitazone 15 mg, 30 mg, and 45 mg) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both cover T2DM treatment with pioglitazone monotherapy, dual therapy, and triple therapy; PBAC specifies adult population already implied by TGA label.