PBAC's latest decision on Amivantamab and lazertinib: Recommended with restriction (2025). Considered for First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with evidence of activating epidermal growth factor receptor mutation (EGFRm), specifically exon 19 deletions or exon 21 L858R substitution mutations.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adult patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, treatment-naive or intolerant to prior EGFR-TKIs in the advanced/metastatic setting, WHO performance status ≤2.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
MARIPOSA
Comparator
osimertinib
Economic model
CEA
ICER note
ICER value redacted or not stated in the provided text excerpt; the document appears truncated at section 3.7.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement (SPA) applies to both amivantamab vial and lazertinib pack. ACM advised prophylactic anticoagulation for at least the first 4 months of therapy with ongoing anticoagulation at clinician discretion due to venous thromboembolism (VTE) risk.