Empagliflozin/MetforminJardiamet

7.1 The PBAC recommended empagliflozin/metformin FDC on a cost-minimisation basis with empagliflozin and metformin taken concomitantly. The equi-effective doses were empagliflozin 5mg/metformin 500mg twice daily and empagliflozin 10mg daily and metformin 500mg twice daily taken concomitantly. 16PSD · Nov 2015

7.2 The PBAC noted that positive recommendations were also made at the November 2015 meeting for empagliflozin in triple oral combination with metformin and a sulfonylurea and in combination with insulin. The PBAC therefore advised that the restriction for empagliflozin/metformin FDC should include use for those indications.PSD · Nov 2015

6.15 The submission presented a cost-minimisation analysis. The equi-effective doses for each of the FDCs are summarised in Table 5. These were consistent with the doses used to demonstrate bioequivalence.PSD · Nov 2015

Table 5: Equi-effective doses for the individual components of each FDC Empagliflozin/metformin FDC Equi-effective doses 5mg/500mg twice daily Empagliflozin 10mg daily/metformin 500mg twice daily 5mg/850mg twice daily Empagliflozin 10mg daily/metformin 850mg twice daily 5mg/1000mg twice daily Empagliflozin 10mg daily/metformin 1000mg twice daily 12.5mg/500mg twice daily Empagliflozin 25mg daily/metformin 500mg twice daily 12.5mg/850mg twice daily …PSD · Nov 2015

6.12 The submission claimed that the empagliflozin/metformin FDC is bioequivalent to the individual components taken concomitantly. This claim has been assessed by the TGA delegate who considered that bioequivalence had been demonstrated for each of the FDC tablets and their co-administered individual components.PSD · Nov 2015

6.13 The submission also claimed that empagliflozin (+ metformin) was non-inferior to the secondary comparator dapagliflozin (+ metformin) in terms of efficacy and safety.PSD · Nov 2015