Empagliflozin with linagliptin

PBAC's latest decision on Empagliflozin with linagliptin: Recommended with restriction (2017). Considered for Type 2 diabetes mellitus in patients uncontrolled on dual oral therapy with either a DPP4 inhibitor or SGLT2 inhibitor in combination with metformin; also for dual therapy in treatment naïve patients with mild to moderate renal impairment uncontrolled on metformin or sulfonylurea monotherapy.

Eligible population

Adults with type 2 diabetes mellitus uncontrolled on dual oral therapy including either a DPP4 inhibitor or SGLT2 inhibitor with metformin (HbA1c >7% or blood glucose >10 mmol/L); separately, treatment naïve patients with mild to moderate renal impairment (eGFR ≥45 <60 mL/min/1.73 m²) uncontrolled on metformin or sulfonylurea monotherapy.

Therapy area

Endocrinology

Line of therapy

Second-line

Evidence base

RCT

Primary endpoint

HbA1c

Key trials

1275.9 (NCT01734785), 1275.10 (NCT01778049), 1275.1 (NCT01426876), EASIE (NCT00751114), DURATION-2 (NCT00637273), DURATION-Neo-2 (NCT01652729)

Comparator

Individual component products (empagliflozin and linagliptin); insulin glargine; exenatide; dapagliflozin with saxagliptin

Economic model

Cost-minimisation

ICER note

Cost-minimisation analyses presented; no ICER (incremental cost-effectiveness ratio) was calculated as comparisons were cost-minimisation only.

Submission history

• Mar 2017: Not recommended · Authority Required
• Nov 2017: Recommended with restriction · Restricted

Similar precedents

• Empagliflozin, empagliflozin with metformin, linagliptin, linagliptin with metformin
  similarity 0.82
• Ertugliflozin with sitagliptin
  similarity 0.82
• Dapagliflozin with sitagliptin
  similarity 0.80
• Linagliptin
  similarity 0.79
• Saxagliptin
  similarity 0.79
• Metformin and saxagliptin
  similarity 0.78