VildagliptinGalvus
Treatment of type 2 diabetes mellitus in patients not adequately controlled on insulin therapy with or without metformin, for use in combination with insulin.
Decisions on record
- Meeting Jul 2013 Not recommended Type 2 diabetes
- Meeting Mar 2010 Recommended Lowers blood sugars
Access path
- TGA registered · Galvus
TGA label equal than the PBS population
- Mar 2010Recommended · restricted
Evidence: RCT, non-inferiority trials, indirect comparisons → Meta-analysis
- Mar 2010Recommended · restricted
Evidence: RCT, non-inferiority trials, indirect comparisons → Meta-analysis
- Jul 2013Not recommended
inappropriate comparator (pioglitazone rejected due to cardiovascular concerns and diminishing use), insufficient…
- ↻ resubmittedMar 2016Recommended · restricted
Comparator changed: mixed comparator of sulfonylurea, acarbose, insulin and exenatide →…
- Nov 2017Recommended · restricted
Comparator changed: dapagliflozin → sitagliptin, linagliptin (primary); dapagliflozin…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (streamlined) listing of vildagliptin and vildagliptin with metformin fixed dose combination (FDC) for use in combination with insulin.PSD · Nov 2017
7.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment, as described above, that the cost-effectiveness of vildagliptin would be acceptable if it were cost-minimised against sitagliptin and linagliptin. Similarly, the cost effectiveness of vildagliptin with metformin in this setting would be acceptable if cost-minimised against the component drugs.PSD · Nov 2017
6.27 These estimates were based on the doses used in the three head-to-head trials and three bio-equivalence trials.PSD · Nov 2017
6.28 The vildagliptin product information (PI) recommends monitoring of liver enzymes prior to initiation of vildagliptin, every 3 months in the first year of therapy and periodically thereafter. The vildagliptin PI also notes that patients who develop increased transaminase levels should be monitored with a second liver function test (LFT) to confirm the finding and be followed thereafter with frequent LFTs until the abnormalities return to normal.PSD · Nov 2017
6.15 The submission described vildagliptin as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety compared with dapagliflozin, sitagliptin and saxagliptin when used in triple therapy with metformin and a sulfonylurea.PSD · Mar 2016
6.16 The submission also re-iterated the claim that vildagliptin/metformin FDC is equivalent to the two components given separately. This claim has been previously accepted by the PBAC (November 2010 PBAC meeting).PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation analysis. PSD · 2010
Decision context
PopulationAdult patients with type 2 diabetes mellitus not adequately controlled on insulin therapy with or without metformin.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | sitagliptin, linagliptin (primary); dapagliflozin, empagliflozin (secondary) | — | RCT · HbA1c reduction |
| Mar 2016 | Recommended · restricted | dapagliflozin | — | RCT · HbA1c |
| Jul 2013 | Not recommended | mixed comparator of sulfonylurea, acarbose, insulin and exenatide | — | Meta-analysis · HbA1c |
| Mar 2010 | Recommended · restricted | sitagliptin | — | RCT, non-inferiority trials, indirect comparisons · HbA1c reduction |
| Mar 2010 | Recommended · restricted | sitagliptin | — | Meta-analysis · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT01076075 | Ph 3 | 427 | Change From Baseline in Hemoglobin A1C (%) at Week 24 | completed |
| NCT01590771 | Ph 3 | 498 | Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Su… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe vildagliptin added to insulin ± metformin in type 2 diabetes patients with inadequate glycaemic control on current therapy.