LinagliptinLINAGLIPTIN DR.REDDY'S
Type 2 diabetes in combination with insulin, with or without metformin, when therapy with insulin (± metformin) does not provide adequate glycaemic control.
Decisions on record
- Meeting Jul 2012 Not recommended Type 2 diabetes
- Meeting Nov 2011 Recommended Type 2 diabetes
- Meeting Jul 2011 Deferred Type 2 diabetes
Access path
- TGA registered · LINAGLIPTIN DR.REDDY'S
TGA label narrower than the PBS population
- Jul 2011Recommended
Evidence: RCT | Meta-analysis → RCT
- Jul 2011Recommended
Evidence: RCT | Meta-analysis → RCT
- Nov 2011Recommended · restricted
- Jul 2012Not recommended
insufficient evidence to accept non-inferiority claim on comparative effectiveness (conflicting indirect comparison…
- Jul 2012Not recommended
Insufficient evidence to accept claim of non-inferiority in comparative effectiveness to pioglitazone triple therapy…
- ↻ resubmittedMar 2016Recommended · restricted
Comparator changed: pioglitazone triple therapy → sitagliptin
- Mar 2016Recommended · restricted
Comparator changed: pioglitazone triple therapy → sitagliptin
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (Streamlined) listing of linagliptin in triple oral combination with metformin and a sulfonylurea on a cost minimisation basis with sitagliptin. The equi-effective doses were linagliptin 5mg and sitagliptin 100mg.PSD · Mar 2016
7.2 The PBAC recommended the Authority Required (Streamlined) listing of linagliptin with metformin (FDC) in combination with a sulfonylurea on a cost minimisation basis to the individual components taken concomitantly. The PBAC noted that the equi- effective doses were based on the results of the bioequivalence trials previously considered by the Committee (April 2013 linagliptin/metformin FDC PSD).PSD · Mar 2016
6.17 The submission presented a cost-minimisation analysis for linagliptin versus sitagliptin. This was consistent with the claim of non-inferiority between linagliptin and sitagliptin.PSD · Mar 2016
6.18 The submission included a cost-minimisation analysis of linagliptin/metformin FDCs against their individual components. This was reasonable.PSD · Mar 2016
6.15 The submission described linagliptin as non-inferior in terms of comparative efficacy and safety to sitagliptin, dapagliflozin and saxagliptin, when used in triple oral therapy with metformin and a sulfonylurea. This claim was adequately supported.PSD · Mar 2016
6.16 The submission reiterated the claim that linagliptin/metformin FDC is equivalent to the individual components taken concomitantly. This claim was previously accepted by the PBAC (April 2013 linagliptin/metformin FDC PSD).PSD · Mar 2016
Cost-effectiveness
Submission was based on cost-minimisation analysis; no ICER stated.
Listing of linagliptin 5mg tablets was requested on a cost-minimisation basis compared to sitagliptin. PSD · 2016
Decision context
PopulationAdults with type 2 diabetes inadequately controlled with insulin (with or without metformin), with HbA1c >7% or blood glucose >10 mmol/L in >20% of tests despite insulin and oral antidiabetic agents.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | sitagliptin | — | Meta-analysis · HbA1c |
| Mar 2016 | Recommended · restricted | sitagliptin and dapagliflozin | — | RCT · HbA1c |
| Jul 2012 | Not recommended | pioglitazone triple therapy | — | RCT | Single-arm | Registry | Cost-minimisation · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (HbA1c levels) |
| Jul 2012 | Not recommended | pioglitazone triple therapy | — | Indirect comparison · HbA1c |
| Nov 2011 | Recommended · restricted | sitagliptin | — | RCT · HbA1c |
| Jul 2011 | Recommended | sitagliptin | — | RCT | Meta-analysis · QoL | Other |
| Jul 2011 | Recommended | sitagliptin | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT01590797 | Ph 3 | 467 | Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to insulin-combination therapy with inadequate glycaemic control despite insulin ± metformin; TGA label includes monotherapy and dual oral combinations without insulin.