PBAC's latest decision on Gefitinib: Not recommended (2013). Considered for First-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 2 submissions
Submissions
3
first 2010
Submissions
3
2010 → 2013
Eligible population
Adults with locally advanced or metastatic (Stage IIIB/IV) non-squamous NSCLC with WHO performance status 0–2 and evidence of activating EGFR mutations.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
IPASS, First-SIGNAL, NEJ002, WJTOG3405
Comparator
platinum-based doublet chemotherapy (carboplatin and paclitaxel)
Economic model
CUA
ICER note
Base case claims dominance but PBAC noted this was biased in favour of gefitinib; sensitivity analyses and revised modelling with erlotinib pricing place ICER in the range $45,000–$75,000/QALY.
ICER basis
Range aggregates 2 submissions (2010–2013) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: uncertain and unacceptably high cost-effectiveness, no overall survival benefit, bias in base case ICER (overestimated second-line gefitinib uptake, underestimated test costs, overestimated chemotherapy adverse event costs), small incremental QALY gains (0.0152 QALY or ~5 days), immature survival data for WJTOG3405, insufficient confidence in EGFR test accuracy
Submission history
Nov 2010: Not recommended · Authority Required — ICER $105k/QALY
Nov 2012: Not recommended
Jul 2013: Not recommended · Authority Required — ICER $75k/QALY