script.reportAU
Oncology

Erlotinib

Brand: Tarceva

PBAC's latest decision on Erlotinib: Recommended with restriction (2013). Considered for 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.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
5
first 2006
Submissions
5
2006 → 2013

Eligible population

Adults 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.

Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
731 patients
Key trials
EURTAC, OPTIMAL, BR.21, IPASS, NEJGSG, Study 0054, WJTOG3405, TORCH, DELTA, TAILOR, FASTACT-2
Comparator
platinum-based doublet chemotherapy (carboplatin and gemcitabine); gefitinib
ICER note
ICER not stated in this PSD; economic model details not presented in the public summary.
ICER (historical)
$15k/QALY–$45k/QALY across 4 submissions (2006–2012) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

Submission history

Similar precedents

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