PBAC's latest decision on Mobocertinib: Recommended with restriction (2023). Considered for Adults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor exon 20 insertion (EGFR ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy (PBC).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2022
Submissions
2
2022 → 2023
Eligible population
Adults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC with EGFR ex20ins mutations who have progressed on or after platinum-based chemotherapy, with WHO performance status ≤ 2.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
Study TAK-788-3001, Study 101, Study 5008, Study 5002
Comparator
chemotherapy
Economic model
CUA
ICER note
ICER value is redacted (shown as '$' in the document). The resubmission proposed a price reduction to achieve an ICER within the range of $45,000–$75,000 per QALY, but the exact ICER is not disclosed in the public summary.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement applies; exact details are not disclosed in the public summary.
Submission history
Nov 2022: Recommended with restriction · Authority Required
Jul 2023: Recommended with restriction · Authority Required