PBAC's latest decision on Liraglutide: Not recommended (2018). Considered for Type 2 diabetes mellitus, specifically for dual combination therapy with metformin or a sulfonylurea, and triple combination therapy with metformin and a sulfonylurea (the current submission additionally sought advice on whether liraglutide 1.2 mg meets Special Pricing Arrangement criteria based on claimed cardiovascular benefits).
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
5
first 2010
Submissions
5
2010 → 2018
Eligible population
Adults with type 2 diabetes mellitus for dual combination therapy with metformin or a sulfonylurea, or triple combination therapy with metformin and a sulfonylurea; the submission also addressed patients at high cardiovascular risk.
Therapy area
Endocrinology
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Key trials
LEADER, EXSCEL
Comparator
exenatide 10 µg twice daily
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. This was a minor submission on cost-minimisation basis with exenatide.
ICER (historical)
$15k/QALY–$45k/QALY across 2 submissions (2010–2011) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: Insufficient evidence that liraglutide 1.2 mg (the listed dose) provides cardiovascular benefits; LEADER trial used 1.8 mg with 84.8% of patients exposed to 1.8 mg, but no evidence that CV benefits extend to 1.2 mg dose; reliance on unsupported assumption that exenatide provides no cardiovascular risk reduction; failure to provide indirect comparison of liraglutide and exenatide with full EXSCEL trial evaluation; does not meet Special Pricing Arrangement criteria (no unique characteristics compared to exenatide b.d., which lacks an SPA)
Submission history
Nov 2010: Recommended with restriction — ICER $75k/QALY
Nov 2011: Not recommended — ICER $45k/QALY
Mar 2013: Recommended with restriction · Authority Required
Jul 2017: Recommended with restriction · Authority Required