PBAC's latest decision on Ibrutinib: Recommended with restriction (2024). Considered for Previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), in combination with venetoclax, for patients suitable for fludarabine-based chemoimmunotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
12
first 2015
PBS spend
$82M
9,692 scripts · 2024
Eligible population
Adults with previously untreated CLL/SLL who would otherwise be considered fit for treatment with fludarabine-based chemoimmunotherapy; receiving fixed duration ibrutinib (420 mg daily for 3 cycles lead-in, then continued with venetoclax for 12 further cycles) in combination with venetoclax.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
CAPTIVATE, GLOW, CLL-14
Comparator
venetoclax + obinutuzumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated by design.
ICER (historical)
$45k/QALY–$75k/QALY across 4 submissions (2015–2018) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $82M in PBS benefits for Ibrutinib in 2024 across 9,692 scripts, at $8,454 per script.
Submission history
Jul 2015: Recommended with restriction · Authority Required
Nov 2015: Noted · Authority Required — ICER $75k/QALY
Mar 2016: Deferred · Authority Required — ICER $75k/QALY
Nov 2016: Not recommended · Restricted
Nov 2016: Recommended with restriction · Authority Required
Nov 2017: Not recommended · Authority Required — ICER $105k/QALY
Nov 2017: Recommended with restriction · Authority Required
Mar 2018: Recommended with restriction · Authority Required — ICER $75k/QALY
Nov 2019: Recommended with restriction · Authority Required
Nov 2020: Recommended · Authority Required
Dec 2022: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required