ErlotinibErlotinib Cipla
Initial and continuing first-line treatment, as monotherapy, of locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or not otherwise specified (NOS) non-small cell lung cancer in patients with evidence of activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material, who do not have progressive disease.
Decisions on record
- Meeting Mar 2014 Not recommended Tarceva® Roche Products Pty Limited Non-small cell lung cancer: - first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. - maintenance therapy in patients with locally advanced or metastatic non-small ce no PSD
- Meeting Jul 2013 Deferred Lung cancer
- Meeting Jul 2012 Not recommended Lung cancer
- Meeting Mar 2008 Recommended Lung Cancer no PSD
- Meeting Nov 2006 Not recommended Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Access path
- TGA registered · Erlotinib Cipla
TGA label narrower than the PBS population
- Mar 2006Recommended
vs docetaxel and best supportive care
- Nov 2006Not recommended
high and uncertain cost effectiveness ratios compared with best supportive care, doubt about claims for…
- ↻ resubmittedNov 2007Recommended
Comparator changed: best supportive care (BSC) → best supportive care
- Nov 2007Recommended
Comparator changed: best supportive care (BSC) → best supportive care
- Jul 2012Not recommended
ICER dropped $75,000 → $45,000 (-40%)
- Jul 2013Not recommended
Comparator changed: platinum-based doublet chemotherapy (no EGFR gene mutation testing) →…
Cost-effectiveness
ICER not stated in this PSD; economic model details not presented in the public summary.
The PBAC considered that the re-modelling exercise with converging curves for survival gain was more plausible than the initial analysis in the submission. However, the incremental cost-effectiveness ratio per life-year gained was unacceptably high. PBAC · 2007
Decision context
PopulationAdults with locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or NOS non-small cell lung cancer with evidence of activating mutation(s) of the EGFR gene, WHO/ECOG performance status 0 to 2, with no evidence of progressive disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Not recommended | platinum-based doublet chemotherapy (carboplatin and gemcitabine); gefitinib | — | RCT · PFS |
| Jul 2012 | Not recommended | platinum-based doublet chemotherapy (no EGFR gene mutation testing) | $15k–45k | RCT · PFS |
| Nov 2007 | Recommended | best supportive care | $45k–75k | RCT · OS |
| Nov 2007 | Recommended | best supportive care | $45k–75k | RCT · OS |
| Nov 2006 | Not recommended | best supportive care (BSC) | $45k–75k | RCT, indirect comparison · OS, PFS, ORR |
| Mar 2006 | Recommended | docetaxel and best supportive care | $45k–75k | RCT, indirect comparisons · OS, PFS |
Clinical evidence
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| EGFR gene mutation testing for erlotinib eligibility in NSCLC | EGFR activating 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 non-squamous/NOS histology and first-line only; TGA label includes all NSCLC histologies and multiple treatment lines.