PBAC's latest decision on Nivolumab: Recommended with restriction (2024). Considered for Perioperative treatment (neoadjuvant plus adjuvant) of patients with resectable non-small cell lung cancer (tumours ≥4 cm or node positive) without known EGFR mutations or ALK rearrangements.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
36
first 2015
PBS spend
$875M
121,146 scripts · 2024
Eligible population
Adults with resectable non-small cell lung cancer (tumours ≥4 cm or node positive), no known EGFR mutations or ALK rearrangements, WHO performance status 0 or 1.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
EFS
Key trials
CM77T, CM816
Comparator
Neoadjuvant nivolumab plus platinum-doublet chemotherapy (main comparator per PSCR)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis versus neoadjuvant nivolumab plus chemotherapy; no numeric ICER presented in public text.
ICER (historical)
$25k/QALY–$35k/QALY across 7 submissions (2016–2024) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $875M in PBS benefits for Nivolumab in 2024 across 121,146 scripts, at $7,224 per script.
Submission history
Jul 2015: Recommended with restriction · Authority Required
Nov 2015: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required
Jul 2016: Recommended with restriction · Restricted
Nov 2016: Recommended with restriction · Restricted
Nov 2016: Recommended with restriction · Restricted — ICER $75k/QALY
Nov 2016: Recommended with restriction · Authority Required
Mar 2017: Recommended with restriction · Restricted — ICER $105k/QALY
Mar 2017: Noted · Authority Required — ICER $75k/QALY
Nov 2017: Recommended with restriction · Authority Required
Mar 2018: Recommended with restriction · Restricted — ICER $105k/QALY
Jul 2018: Recommended with restriction · Authority Required
Nov 2018: Recommended with restriction · Restricted
Mar 2019: Recommended with restriction · Restricted
Mar 2019: Recommended with restriction · Restricted
Jul 2019: Recommended with restriction · Restricted
Nov 2019: Recommended with restriction · Restricted
Nov 2019: Recommended with restriction · Authority Required
Mar 2021: Noted · Restricted
Jul 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required — ICER $95k/QALY
Jul 2022: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Authority Required
Nov 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Restricted
Jul 2023: Recommended with restriction · Authority Required
Jul 2023: Not recommended · Authority Required — ICER $35k/QALY
Nov 2023: Recommended with restriction · Authority Required
Nov 2023: Not recommended · Authority Required
Mar 2024: Deferred · Authority Required — ICER $35k/QALY
Nov 2024: Recommended with restriction · Authority Required
Dec 2024: Recommended with restriction · Authority Required