Rosiglitazone Maleate With Metformin HydrochlorideAvandamet
Type 2 diabetes mellitus in patients with inadequate glycaemic control on metformin alone or in combination with a sulfonylurea, for dual therapy or triple therapy with a sulfonylurea.
Access path
- TGA registered · Avandamet
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
Listing: Authority required → Authority Required
- Jul 2006Recommended · restricted
Listing: Authority required → Authority Required
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis only; no ICER calculated
The choice of the cost-minimisation approach was valid. PBAC · 2006
Decision context
PopulationType 2 diabetes mellitus patients with HbA1c greater than 7% despite maximally tolerated doses of metformin, in whom combination therapy with a sulfonylurea is contraindicated or not tolerated, or patients stabilised on rosiglitazone and metformin.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | concomitant rosiglitazone and metformin taken as individual tablets | — | RCT · HbA1c |
| Jul 2006 | Recommended · restricted | concomitant rosiglitazone and metformin taken as individual tablets | — | RCT · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate control on maximally tolerated metformin doses; TGA label includes those inadequately treated on metformin alone without dosing specification.