Saxagliptin With MetforminKombiglyze XR
Type 2 diabetes mellitus in patients whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, thiazolidinedione or glucagon-like peptide-1 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
- Mar 2013Deferred
vs saxagliptin 5 mg once daily and metformin 500 mg, 850 mg or…
- Apr 2013Recommended
Comparator changed: saxagliptin 5 mg once daily and metformin 500 mg, 850 mg or 1000 mg…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as submission claimed bioequivalence to individual components.
Decision context
PopulationAdults with type 2 diabetes mellitus whose HbA1c is greater than 7% despite treatment with metformin alone, where sulfonylurea combination therapy is contraindicated or not tolerated, and requiring initiation of a DPP-4 inhibitor, thiazolidinedione, or GLP-1 agonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Apr 2013 | Recommended | saxagliptin 5 mg once daily and metformin (500 mg, 850 mg, or 1000 mg) as individual components | — | RCT · HbA1c reduction |
| Mar 2013 | Deferred | saxagliptin 5 mg once daily and metformin 500 mg, 850 mg or 1000 mg as individual components | — | RCT · HbA1c reduction |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HbA1c >7% despite metformin, sulfonylurea contraindicated/intolerant, third-line use; TGA label has no such criteria.