PBAC's latest decision on Futibatinib: Not recommended (2025). Considered for Locally advanced or metastatic cholangiocarcinoma in patients with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Adult patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
Single-arm
Primary endpoint
OS
Pivotal trial size
103 patients
Key trials
FOENIX-CCA2, ABC-06
Comparator
FOLFOX (modified FOLFOX 6 chemotherapy)
Economic model
CUA
ICER note
Resubmission ICER presented in redacted range; previous submission base case was $95,000 to < $115,000 per QALY. Current resubmission targeted ICER of less than $75,000 per QALY.
ICER (historical)
$75k/QALY–$95k/QALY in an earlier submission (2025) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: Uncertain clinical benefit likely overestimated in MAIC, unanchored MAIC confers high risk of bias, conservative indirect comparisons (Paine 2022, Borad 2022) show less favourable HRs, economic model uncertainties persist despite revisions, ICER threshold expectations not met
Submission history
Mar 2025: Recommended with restriction · Authority Required
Jul 2025: Not recommended · Authority Required — ICER $95k/QALY