PBAC's latest decision on Acalabrutinib: Recommended with restriction (2025). Considered for Previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in combination with venetoclax as a fixed duration regimen.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
10
first 2020
PBS spend
$65M
8,299 scripts · 2024
Eligible population
Patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) with active disease, receiving acalabrutinib in combination with venetoclax as a fixed duration regimen
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
AMPLIFY, CLL13, CRISTALLO, CLL14, GLOW, CAPTIVATE
Comparator
Ibrutinib in combination with venetoclax (IV) and venetoclax in combination with obinutuzumab (VO)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis with no ICER calculated; economic values are commercially sensitive and redacted in the public document
PBS expenditure
The Australian government paid $65M in PBS benefits for Acalabrutinib in 2024 across 8,299 scripts, at $7,826 per script.
Submission history
Mar 2020: Recommended with restriction · Authority Required
Jul 2020: Recommended with restriction · Authority Required
Jul 2020: Recommended with restriction · Restricted
Jul 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Dec 2022: Recommended with restriction · Authority Required
Mar 2023: Not recommended · Restricted
Jul 2023: Noted · Authority Required
Jul 2025: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required