Dapagliflozin And Metformin Extended Release
Treatment of type 2 diabetes mellitus in adults as add-on to insulin therapy or as triple oral therapy in combination with a sulfonylurea.
Access path
- Jul 2014Recommended · restricted
vs co-administered dapagliflozin and metformin XR or metformin…
- Jul 2015Recommended
Evidence: Single-arm → Cost-minimisation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended that the listing of dapagliflozin+metformin XR for the treatment of type 2 diabetes mellitus be extended to include use in the Add On to Insulin and Triple Oral Therapy settings, consistent with the current listings for dapagliflozin. The requested restrictions are consistent with the TGA indication and previous recommendations of the PBAC.PSD · Jul 2015
6.2 In its consideration of sitagliptin for triple oral therapy in July 2015, the PBAC agreed that the listings for DPP-4 inhibitors and SGLT2 inhibitors for triple oral therapy in type 2 diabetes mellitus should be consistent.PSD · Jul 2015
6.10 Based on the results of the three bioequivalence trials, the submission claimed that dapagliflozin/metformin XR FDC is equivalent on a milligram per milligram basis to corresponding doses of the individual components.PSD · Jul 2014
- Dapagliflozin/metformin XR FDC 10mg/500mg and dapagliflozin 10mg with 5PSD · Jul 2014
6.7 The submission described dapagliflozin/metformin XR FDC as bioequivalent to the individual components administered concomitantly. The submission makes no claims with regard to comparative safety. The PBAC noted that the claim of bioequivalence has been accepted by the TGA.PSD · Jul 2014
6.8 The PBAC considered that a conclusion of comparative effectiveness was reasonable.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation analysis based on bioequivalence; no ICER calculated.
The submission presented a cost-minimisation analysis based on non-inferiority between dapagliflozin+metformin XR and the individual components, on grounds of bioequivalence. PSD · 2015
Decision context
PopulationAdults with type 2 diabetes mellitus inadequately controlled on insulin with oral antidiabetic agents (for add-on to insulin setting) or on metformin and a sulfonylurea (for triple oral therapy setting), with HbA1c greater than 7% or blood glucose levels greater than 10 mmol/L in more than 20% of tests over 2 weeks.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended | — | — | Cost-minimisation |
| Jul 2014 | Recommended · restricted | co-administered dapagliflozin and metformin XR or metformin IR | — | Single-arm · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific prior therapy failures (insulin inadequately controlled, or metformin+sulfonylurea) with glycaemic thresholds; TGA label is broader adjunct indication.