PBAC's latest decision on Zanubrutinib: Recommended (2025). Considered for Treatment of relapsed or refractory mantle cell lymphoma (MCL), Waldenström macroglobulinaemia (WM), treatment-naïve and relapsed/refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
7
first 2021
PBS spend
$77M
9,625 scripts · 2024
Eligible population
Adults with relapsed or refractory mantle cell lymphoma, Waldenström macroglobulinaemia, treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma, and those with relapsed/refractory CLL/SLL.
Therapy area
Haematology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
Bioequivalence
Key trials
BGB-3111-114, BGB-3111-115
Comparator
zanubrutinib 80 mg capsule
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as the 160 mg tablet is claimed to be bioequivalent to the 80 mg capsule with identical daily cost.
PBS expenditure
The Australian government paid $77M in PBS benefits for Zanubrutinib in 2024 across 9,625 scripts, at $7,981 per script.
Submission history
Jul 2021: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required