Saxagliptin And Metformin Extended Release
Extension of PBS indication for saxagliptin+metformin XR to include use in combination with a sulfonylurea (triple oral therapy) for the treatment of type 2 diabetes mellitus.
Access path
- Jul 2015Recommended
vs saxagliptin and metformin administered as separate…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended that the listing of saxagliptin+MET XR for the treatment of T2DM be extended to include use in combination with a SU (triple oral therapy).PSD · Jul 2015
5.2 The PBAC recalled that at its November 2013 meeting it had accepted that saxagliptin+MET XR is similar in efficacy and safety to the co-administration of the same doses of the individual components.PSD · Jul 2015
Cost-effectiveness
This was a minor submission based on cost-minimisation analysis using bioequivalence data from previous submissions. No new ICER was calculated.
The PBAC recalled that at its November 2013 meeting it had accepted that saxagliptin+MET XR is similar in efficacy and safety to the co-administration of the same doses of the individual components. PBAC · 2015
Decision context
PopulationAdults with type 2 diabetes mellitus with HbA1c greater than 7% prior to initiation of a DPP4 inhibitor, thiazolidinedione, glucagon-like peptide-1, or SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea, or with alternative blood glucose monitoring criteria where HbA1c is clinically inappropriate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended | saxagliptin and metformin administered as separate components; sitagliptin+metformin FDC | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line triple therapy in inadequately controlled patients; TGA label permits any adjunctive use with saxagliptin+metformin.