PBAC's latest decision on Regorafenib: Recommended with restriction (2021). Considered for Treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered suitable candidates for, fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF therapy, and if RAS wildtype, anti-EGFR therapy.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
6
first 2014
Submissions
6
2014 → 2021
Eligible population
Adults with metastatic colorectal cancer who have previously failed or are unsuitable for fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF therapy, and if RAS wildtype, anti-EGFR therapy, with WHO performance status ≤1
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Meta-analysis
Primary endpoint
OS
Pivotal trial size
961 patients
Key trials
CORRECT, CONCUR, RECOURSE, TERRA, J003
Comparator
trifluridine/tipiracil
Economic model
Cost-minimisation
ICER note
Cost minimisation approach versus trifluridine/tipiracil; no numeric ICER stated in this excerpt
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2014–2019) — 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 — Regorafenib joining existing trifluridine/tipiracil risk sharing arrangement (RSA) to manage risk of leakage to patients with WHO performance status >1 and sequential use beyond third line