PBAC's latest decision on Dapagliflozin/saxagliptin: Deferred (2017). Considered for Type 2 diabetes in adults with inadequate glycaemic control on dual therapy of metformin and a dipeptidyl peptidase 4 (DPP4) inhibitor.
PBAC outcome
Deferred
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2017
Submissions
1
2017 → 2017
Eligible population
Adults with type 2 diabetes who do not achieve glycaemic control on dual therapy of metformin and any DPP4 inhibitor.
Therapy area
Diabetes
Line of therapy
Third-line
Evidence base
RCT
Primary endpoint
Bioequivalence (pharmacokinetic parameters); supportive efficacy data from trials on HbA1c change
Pivotal trial size
72 patients
Key trials
Study 341, Study 129, Study 10
Comparator
individual components of dapagliflozin 10 mg and saxagliptin 5 mg
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission based on bioequivalence rather than cost-effectiveness.