PBAC's latest decision on Ertugliflozin: Recommended (2018). Considered for Type 2 diabetes mellitus in patients inadequately controlled with metformin or a sulfonylurea, for dual oral therapy with metformin or a sulfonylurea (15 mg strength) or as fixed-dose combination products with metformin.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2018
Submissions
2
2018 → 2018
Eligible population
Adults with Type 2 diabetes mellitus inadequately controlled (HbA1c >7%) with metformin or a sulfonylurea, treated with ertugliflozin 15 mg in dual therapy with metformin or sulfonylurea, or with ertugliflozin 7.5 mg/metformin fixed-dose combination products.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
HbA1c reduction
Pivotal trial size
1,543 patients
Key trials
PBO Pool (three Phase III placebo-controlled trials)
Comparator
dapagliflozin, empagliflozin
Economic model
Not modelled
ICER note
This was a minor resubmission for higher strength formulations; no economic evaluation or ICER was modelled or presented.
Submission history
Mar 2018: Recommended with restriction · Authority Required