script.reportAU
Register
← The record

Linagliptin With Metformin HydrochlorideTrajentamet

Recommended EndocrinologyAuthority RequiredSecond-line line

Type 2 diabetes mellitus in patients with HbA1c greater than 7% despite treatment with metformin, where a combination of metformin and a sulfonylurea is contraindicated or not tolerated, prior to initiation of a dipeptidyl peptidase-4 inhibitor, thiazolidinedione, or glucagon-like peptide-1 agonist.

2
Submissions
2013–13
On the record
—
ICER range
Cost-min
Cost basis

Access path

2 submissions · public record
  1. TGA registered · Trajentamet

    TGA label narrower than the PBS population

  2. Mar 2013
    Deferred

    vs linagliptin and metformin constituent tablets

  3. Mar 2013
    Recommended
  4. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis performed; no ICER calculated as submission claimed bioequivalence to constituent tablets.

Cost-effectiveness accepted ×2

Decision context

PopulationAdults with type 2 diabetes mellitus whose HbA1c is greater than 7% despite treatment with metformin alone, where metformin plus sulfonylurea is contraindicated or not tolerated.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Mar 2013 Deferred linagliptin and metformin constituent tablets — RCT · HbA1c reduction
Mar 2013 Recommended linagliptin and metformin constituent tablets — RCT · HbA1c reduction

Similar precedents

By decision profile
Linagliptin91%Metformin And Sitagliptin84%Alogliptin With Metformin81%Empagliflozin, Empagliflozin With Metformin, Linagliptin, Linagliptin With Metformin82%Saxagliptin With Metformin79%Vildagliptin/Metformin78%Empagliflozin With Linagliptin78%Metformin And Saxagliptin78%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to second-line use with HbA1c >7% despite metformin monotherapy and contraindication to sulfonylureas; TGA label has no such restrictions.

Product Information ↗ ARTG search ↗