GefitinibCIPLA GEFITINIB
First-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations.
Decisions on record
- Meeting Jul 2013 Deferred Lung cancer
- Meeting Nov 2012 Not recommended Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose tumours express activating mutations of the EGFR TK (tyrosine kinase).
- Meeting Mar 2012 Recommended Lung cancer no PSD
- Meeting Nov 2010 Not recommended Anti-cancer drug
- Meeting Nov 2009 Recommended Anti-cancer drug no PSD
- Meeting Mar 2008 Recommended Lung cancer no PSD
- Meeting Mar 2008 Not recommended Lung cancer no PSD
- Meeting Jul 2004 Recommended A selective inhibitor of epidermal growth factor receptor tyrosine kinase used to treat locally advanced or metastatic non-small cell lung cancer. no PSD
Access path
- TGA registered · CIPLA GEFITINIB
TGA label narrower than the PBS population
- Nov 2010Not recommended
No overall survival benefit (ITT analysis showed HR 1.0, 95% CI 0.76–1.33, median OS 21.6 vs 21.9 months); submission's…
- Nov 2012Not recommended
uncertain overall survival benefit, high and uncertain cost-effectiveness, uncertainties regarding prevalence of EGFR…
- ↻ resubmittedNov 2012Recommended · restricted
Comparator changed: platinum-based chemotherapy (carboplatin and paclitaxel) →…
- Jul 2013Recommended
Comparator changed: carboplatin and paclitaxel → platinum-based doublet chemotherapy…
- PBS listing · Authority Required
Cost-effectiveness
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.
Depending upon the various assumptions in the model, the PBAC noted the incremental cost-effectiveness ratio (ICER) could range from dominant to $45,000 - $75000/QALY. PBAC · 2013
Decision context
PopulationAdults with locally advanced or metastatic (Stage IIIB/IV) non-squamous NSCLC with WHO performance status 0–2 and evidence of activating EGFR mutations.
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | platinum-based doublet chemotherapy (carboplatin and paclitaxel) | $45k–75k | RCT · PFS |
| Nov 2012 | Not recommended | carboplatin and paclitaxel | — | RCT, Meta-analysis · PFS |
| Nov 2012 | Recommended · restricted | carboplatin and paclitaxel | — | RCT · PFS |
| Nov 2010 | Not recommended | platinum-based chemotherapy (carboplatin and paclitaxel) | $15k–105k | RCT · PFS | OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| IPASS | Ph 3 | 1,329 | Median Progression Free Survival (PFS) in Months | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| EGFR mutation testing for gefitinib in locally advanced or metastatic non-squamous NSCLC | EGFR mutation | supported with conditions | 2012 |
| EGFR mutation testing in locally advanced or metastatic NSCLC | EGFR mutation | supported | 2020 |
| Small gene panel testing for NSCLC | EGFR, ALK, ROS1, MET exon 14, BRAF, KRAS, RET, NTRK1, NTRK2, NTRK3 | supported | 2022 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line treatment and non-squamous histology; TGA label includes all lines and histologies with EGFR mutations.