SaxagliptinOnglyza
Treatment of patients with type 2 diabetes mellitus in combination with metformin and a sulfonylurea (triple oral therapy).
Decisions on record
- Meeting Jul 2017 Deferred Type 2 diabetes mellitus (T2DM)
- Meeting Jul 2015 Recommended Type 2 diabetes mellitus
- Meeting Jul 2015 Recommended Type 2 diabetes mellitus
- Meeting Jul 2012 Not recommended Type 2 diabetes
- Meeting Nov 2011 Recommended Type 2 diabetes no PSD
- Meeting Mar 2010 Recommended Lowers blood sugars
Access path
- TGA registered · Onglyza
TGA label narrower than the PBS population
- Mar 2010Recommended · restricted
vs sitagliptin
- Jul 2012Not recommended
Inadequate clinical evidence to support non-inferiority claim versus pioglitazone, uncertain comparative clinical…
- Jul 2012Not recommended
inadequate comparison across appropriate comparators, uncertain comparative clinical effectiveness, insufficient…
- ↻ resubmittedJul 2015Recommended
Comparator changed: pioglitazone; insulin also considered as a comparator → dapagliflozin
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of saxagliptin for the treatment of T2DM in combination with MET and SU (triple oral therapy). The recommendation was formed on the basis of a cost-minimisation analysis compared with dapagliflozin in combination with MET and a SU. The equi-effective doses are saxagliptin 5mg and dapagliflozin 10mg.PSD · Jul 2015
7.2 The PBAC accepted that saxagliptin used in combination with MET and a SU is non-inferior to dapagliflozin in combination with MET and a SU in terms of clinical effectiveness and safety.PSD · Jul 2015
6.27 The submission presented a cost minimisation analysis versus insulin glargine and exenatide, with a cost analysis including non-drug costs related to administration and diabetes management. An analysis versus dapagliflozin was not presented in the submission.PSD · Jul 2015
6.28 The equi-effective doses were estimated as saxagliptin 5mg (oral) = insulin glarginePSD · Jul 2015
6.19 The submission described saxagliptin 5mg as similar in terms of comparative effectiveness and non-inferior in terms of comparative safety to insulin glargine 24IU/day (in combination with MET and a SU): This claim may not be adequately supported in terms of comparative efficacy.PSD · Jul 2015
The indirect comparison showed no statistically significant difference in reduction of HbA1c between saxagliptin 5mg and insulin glargine 24IU daily. However, the upper limit of the 95% confidence interval exceeded the accepted MCID of 0.4% and non-inferiority was not demonstrated. In terms of safety, saxagliptin was associated with less weight gain compared with insulin glargine, and a lower risk of hypoglycaemia events in the long term safety studies.PSD · Jul 2015
6.2 The PBAC noted and welcomed the input from a health care professional (1) via the Consumer Comments facility on the PBS website. The comment described the benefits of listing saxagliptin for triple oral therapy, including the availability of an additional treatment before considering insulin and better compliance and outcomes for patients with poorly controlled diabetes.PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER reported. Submission was assessed on cost-minimisation basis compared to insulin glargine, exenatide, and dapagliflozin.
The PBAC considered that on the basis of inadequate clinical evidence to support a claim of non-inferiority, the cost minimisation analysis was not valid. PBAC · 2012
Decision context
PopulationAdults with type 2 diabetes mellitus inadequately controlled on maximally tolerated doses of metformin and a sulfonylurea, with HbA1c >7% or blood glucose >10 mmol/L in >20% of tests over 2 weeks.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended | dapagliflozin | — | RCT · HbA1c |
| Jul 2012 | Not recommended | pioglitazone | — | RCT · HbA1c |
| Jul 2012 | Not recommended | pioglitazone; insulin also considered as a comparator | — | RCT · HbA1c |
| Mar 2010 | Recommended · restricted | sitagliptin | — | RCT | Indirect comparison · HbA1c % change from baseline at week 18, HbA1c % change from baseline at Week 24 |
Consumer voice
A healthcare professional submitted a comment describing the benefits of listing saxagliptin for triple oral therapy, including providing an additional treatment option before insulin and improving compliance and outcomes for patients with poorly controlled diabetes.
the benefits of listing saxagliptin for triple oral therapy, including the availability of an additional treatment before considering insulin and better compliance and outcomes for patients with poorly controlled diabetes Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to triple therapy (metformin + sulfonylurea) with specific glycemic failure thresholds; TGA label includes dual and triple combinations without such thresholds.