Linagliptin

PBAC's latest decision on Linagliptin: Recommended with restriction (2016). Considered for Type 2 diabetes in combination with insulin, with or without metformin, when therapy with insulin (± metformin) does not provide adequate glycaemic control.

Eligible population

Adults 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.

Therapy area

Endocrinology

Line of therapy

Any

Evidence base

RCT

Primary endpoint

HbA1c

Pivotal trial size

1,263 patients

Key trials

1218.36, 1218.43, 1218.63, CT-006, Vilsboll 2010, Mathieu 2015, NCT01590797

Comparator

sitagliptin and dapagliflozin

Economic model

Cost-minimisation

ICER note

Submission was based on cost-minimisation analysis; no ICER stated.

Submission history

• Jul 2011: Deferred
• Jul 2011: Recommended
• Jul 2012: Not recommended · Authority Required (STREAMLINED)
• Mar 2016: Recommended with restriction · Restricted
• Mar 2016: Recommended with restriction · Authority Required

Similar precedents

• Linagliptin with metformin hydrochloride
  similarity 0.90
• Empagliflozin, empagliflozin with metformin, linagliptin, linagliptin with metformin
  similarity 0.83
• Sitagliptin phosphate
  similarity 0.79
• Sitagliptin
  similarity 0.79
• Empagliflozin with linagliptin
  similarity 0.79
• Dulaglutide
  similarity 0.79