Sitagliptin PhosphateJanuvia
Type 2 diabetes mellitus in combination with metformin or a sulfonylurea, where HbA1c remains greater than 7% despite monotherapy and where combination with sulfonylurea is contraindicated or not tolerated (Proposals A and B), or as earlier replacement of sulfonylurea in dual therapy with metformin (Proposal C).
Decision on record
- Meeting Mar 2008 Recommended Type 2 diabetes
Access path
- TGA registered · Januvia
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
vs rosiglitazone (Proposal A), placebo (Proposal B), glipizide…
- PBS listing · Authority Required
Cost-effectiveness
The PSD does not state a numeric ICER value. Section 10 ('Economic Analysis') is incomplete/truncated in the provided text.
Decision context
PopulationAdults aged 18 years and older with type 2 diabetes whose HbA1c is greater than 7% despite treatment with metformin monotherapy or sulfonylurea monotherapy, in whom combination therapy with metformin and sulfonylurea is contraindicated or not tolerated.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | rosiglitazone (Proposal A), placebo (Proposal B), glipizide (Proposal C) | — | RCT · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HbA1c >7% despite monotherapy and specific contraindications/intolerances; TGA label has no glycemic threshold or prior therapy requirement.