Ertugliflozin

6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of the 15 mg dose strength ertugliflozin for dual oral therapy with metformin or a sulfonylurea, and the 7.5 mg ertugliflozin with 500 mg metformin and 7.5 mg ertugliflozin with 1 g 6PSD · Jul 2018

6.2 Following receipt of a positive TGA Delegate’s Overview, and clinical justification for accepting the higher strength of ertugliflozin, the PBAC advised of its recommendation whilst noting that there remained a limited clinical need for the higher strength products.PSD · Jul 2018

6.38 The equi-effective doses were estimated as ertugliflozin 5 mg or 15 mg, once daily and dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg, once daily. Estimates of equi-effectiveness were trial based. Equi-effectiveness of the comparators was derived from Therapeutic Relativity Sheets.PSD · Mar 2018

6.39 Results of the cost-minimisation analysis for ertugliflozin are presented in Table 10. 15PSD · Mar 2018

6.31 The submission described ertugliflozin 5 mg and 15 mg as non-inferior in terms of effectiveness compared with dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg, when used in dual oral combination with metformin for the treatment of patients with type 2 diabetes. The submission described ertugliflozin 5 mg and 15 mg as non-inferior in terms of safety compared to dapagliflozin or empagliflozin, when 14PSD · Mar 2018

6.32 The PBAC considered that the evidence provided in the submission did not support the clinical need for the 15 mg ertugliflozin or 7.5 mg ertugliflozin with 500 mg/1 g metformin fixed dose combinations for listing, especially given the doubt as to the non-inferior safety profile compared to their respective comparators.PSD · Mar 2018