Metformin And SaxagliptinKombiglyze XR
Treatment of type 2 diabetes mellitus in patients with HbA1c greater than 7% despite treatment with metformin, where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.
Decision on record
- Meeting Apr 2013 Recommended Diabetes
Access path
- TGA registered · Kombiglyze XR
TGA label narrower than the PBS population
- Nov 2013Recommended · restricted
vs metformin XR and saxagliptin as individual components…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC considered cost-effectiveness acceptable if cost-minimised against alogliptin/metformin FDC.
For the reasons outlined below, the PBAC considered that the cost-effectiveness of the metformin XR/saxagliptin FDC would be acceptable if it were cost-minimised against the alogliptin/metformin FDC. PBAC · 2013
Decision context
PopulationAdults with type 2 diabetes mellitus whose HbA1c is greater than 7% despite treatment with metformin and who are unable to use metformin in combination with a sulfonylurea due to contraindication or intolerance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | metformin XR and saxagliptin as individual components; other metformin/gliptin fixed-dose combinations | — | RCT · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use (metformin failure) with HbA1c >7% and sulfonylurea contraindication/intolerance; TGA label permits use as adjunct when both drugs appropriate.