PBAC's latest decision on Afatinib dimaleate: Not recommended (2015). Considered for First or subsequent line treatment of locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion mutations.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adults with locally advanced (stage IIIB) or metastatic (stage IV) non-squamous or not otherwise specified NSCLC with evidence of EGFR exon 19 deletion mutations, WHO/ECOG performance status 0–2, previously untreated or intolerant to another EGFR TKI.
ICER not stated; submission was based on cost-minimisation argument with comparators, but PBAC did not accept the proposal.
Why PBAC said no
Reasons cited in the latest PSD: Proposed population restriction to exon 19 deletion mutations not consistent with previous PBAC recommendations for all activating EGFR mutations; inability to obtain special pricing arrangement (SPA) for afatinib; PBAC did not accept that afatinib has unique characteristics compared to erlotinib and gefitinib; exchangeability concerns regarding indirect comparisons between trials due to different chemotherapy regimens and baseline characteristics; requested listing restriction to ECOG performance status 0–2 not supported by trial populations (LUX Lung 3 and 6 enrolled ECOG 0–1 only)