Canagliflozin
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.
Decision on record
- Meeting Jul 2013 Recommended Type 2 diabetes
Access path
- Jul 2013Recommended · restricted
vs sitagliptin
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated as submission claimed equi-effectiveness based on HbA1c outcomes.
The submission presented a cost-minimisation analysis, based on non-inferiority claim of canagliflozin 300 mg to sitagliptin 100 mg for mean reduction in HbA1c from baseline. PSD · 2013
Decision context
PopulationAdults 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.
Risk sharingRisk 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended · restricted | sitagliptin | — | RCT · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to dual oral combination therapy with specific agents (metformin or sulfonylurea) and HbA1c >7% despite prior monotherapy; TGA label permits monotherapy and broader combination options.