PBAC's latest decision on Lenvatinib: Recommended (2018). Considered for Advanced (unresectable) Barcelona Clinic Liver Cancer stage B or stage C hepatocellular carcinoma, first-line treatment.
PBAC outcome
Recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
8
first 2015
Submissions
8
2015 → 2018
Eligible population
Patients with advanced (unresectable) Barcelona Clinic Liver Cancer stage B or stage C hepatocellular carcinoma, who are not suitable for transarterial chemoembolisation, have WHO performance status ≤2, are Child-Pugh class A, and have not received prior VEGF tyrosine kinase inhibitor therapy or have developed intolerance necessitating permanent withdrawal.
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
Study 304
Comparator
sorafenib
Economic model
Cost-minimisation
Eligible patients/year
50
ICER note
Cost-minimisation analysis; no ICER calculated as lenvatinib and sorafenib are cost-equivalent on an equi-effective dose basis.
ICER (historical)
$45k/QALY–$75k/QALY across 3 submissions (2016–2018) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk-share arrangement including a financial cap in place for lenvatinib 4 mg (30 tablets). The PBAC further recommended that the drug cost for lenvatinib be no more than 5% higher than sorafenib using the previously recommended equi-effective doses.
Submission history
Nov 2015: Noted · Authority Required
Mar 2016: Not recommended · Authority Required — ICER $75k/QALY
Jul 2016: Recommended with restriction · Restricted — ICER $75k/QALY
Nov 2017: Not recommended · Authority Required
Mar 2018: Not recommended · Authority Required — ICER $75k/QALY
Jul 2018: Recommended with restriction · Restricted
Jul 2018: Recommended with restriction · Authority Required