PBAC's latest decision on Cabozantinib: Not recommended (2025). Considered for Treatment of adult patients with unresectable locally advanced or metastatic well- or moderately-differentiated pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET) after prior systemic therapy.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
10
first 2017
Submissions
10
2017 → 2025
Eligible population
Adult patients (aged ≥18 years) with unresectable locally advanced or metastatic well- or moderately-differentiated pNET or epNET who have progressive disease on prior systemic therapy or developed intolerance necessitating treatment withdrawal, with WHO grade 0, 1 or 2 disease.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
CABINET
Comparator
Sunitinib (pNET third-line), chemotherapy (epNET third-line), best supportive care (fourth-line both populations)
Economic model
Cost-minimisation (third-line) and CEA (fourth-line)
ICER note
No numeric ICER values stated in the public summary document. Cost-minimisation analysis requested for third-line pNET vs sunitinib and third-line epNET vs chemotherapy; cost-effectiveness analysis vs placebo/BSC requested for fourth-line settings, but specific ICER values are not disclosed in this PSD.
ICER (historical)
$55k/QALY–$75k/QALY in an earlier submission (2024) — 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: Unclear place in therapy across requested populations; inconsistent restrictions compared to nominated comparators (sunitinib, everolimus); inclusion of locally advanced and moderately-differentiated disease with inadequate efficacy data in these subgroups; absence of ECOG performance status criterion; lack of requirement for prior progression on specific systemic therapies other than SSA; proposed solo therapy requirement inconsistent with CABINET trial protocol which permitted concomitant SSA use; WHO grade 0, 1, or 2 criterion does not align with WHO classification system; lack of one-course-per-lifetime restriction; potential need for flow-on changes to existing SSA listings not adequately addressed
Submission history
Dec 2017: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Restricted
Jul 2019: Recommended with restriction · Restricted
Mar 2020: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Restricted — ICER $75k/QALY
Mar 2024: Recommended with restriction · Authority Required (STREAMLINED)