PBAC's latest decision on Cemiplimab: Recommended with restriction (2023). Considered for First-line treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations, in combination with platinum doublet chemotherapy, irrespective of histology or PD-L1 expression levels.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2020
PBS spend
$215M
28,838 scripts · 2024
Eligible population
Adult patients with Stage IV (metastatic) NSCLC without EGFR, ALK, or ROS1 aberrations, who have not previously received systemic therapy for advanced NSCLC, with WHO performance status 0 or 1
Therapy area
Oncology
Line of therapy
First-line
Evidence base
Meta-analysis
Primary endpoint
OS
Pivotal trial size
1,641 patients
Key trials
Study 16113, KN-189, KN-407
Comparator
pembrolizumab in combination with platinum doublet chemotherapy
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement (SPA) applies
PBS expenditure
The Australian government paid $215M in PBS benefits for Cemiplimab in 2024 across 28,838 scripts, at $7,470 per script.
Submission history
Nov 2020: Recommended with restriction · Restricted
Nov 2021: Recommended with restriction · Restricted
Mar 2022: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required