PBAC's latest decision on Crizotinib: Recommended with restriction (2018). Considered for Treatment of patients with locally advanced (Stage IIIB) or metastatic (Stage IV) ROS1-positive non-small cell lung cancer (NSCLC).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 4 submissions
Submissions
6
first 2013
Submissions
6
2013 → 2018
Eligible population
Adults with locally advanced (Stage IIIB) or metastatic (Stage IV) non-squamous or not otherwise specified type NSCLC with ROS1 gene rearrangement (≥15% positive cells by FISH testing) and WHO performance status ≤2.
Therapy area
Oncology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
PFS
Key trials
A8081001, OO12-01
Comparator
pemetrexed
Economic model
CUA
ICER basis
Range aggregates 4 submissions (2014–2018) — not a single base case.
Submission history
Nov 2013: Recommended with restriction · Authority Required
Mar 2014: Deferred · Authority Required — ICER $75k/QALY
Nov 2014: Recommended with restriction · Restricted — ICER $200k/QALY
Mar 2017: Noted · Restricted — ICER $75k/QALY
Nov 2017: Recommended with restriction · Authority Required