PBAC's latest decision on Canagliflozin: Recommended with restriction (2013). Considered for Type 2 diabetes mellitus as dual oral combination therapy with metformin or a sulfonylurea in patients whose HbA1c is greater than 7% despite treatment with either metformin or a sulfonylurea and where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
Adults with type 2 diabetes mellitus in combination with metformin or a sulfonylurea, with HbA1c greater than 7% despite treatment with either metformin or a sulfonylurea, where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.
Therapy area
Endocrinology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
HbA1c
Pivotal trial size
735 patients
Key trials
Study 3006, Study 3015, Study 3008
Comparator
sitagliptin
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated as submission claimed equi-effectiveness based on HbA1c outcomes.
Risk sharing
Risk-sharing arrangement in place — Risk share agreement proposed to manage potential use outside of the third-line restriction proposed by the submission, given concerns about off-label prescribing patterns observed with other antidiabetic agents.