script.reportAU
Haematology

Venetoclax

Brand: Venclexta

PBAC's latest decision on Venetoclax: Recommended with restriction (2021). Considered for Treatment of newly diagnosed acute myeloid leukaemia (AML) in adults ineligible for standard intensive remission induction chemotherapy, in combination with azacitidine.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$95k/QALY
$75k/QALY–$95k/QALY · across 3 submissions
Submissions
8
first 2017
PBS spend
$74M
12,115 scripts · 2024

Eligible population

Adults with newly diagnosed acute myeloid leukaemia ineligible for standard intensive induction chemotherapy.

Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
M15-656, AZA-AML-001, CURRENT study
Comparator
azacitidine (primary); low-dose cytarabine (secondary)
Economic model
CUA
Budget impact
$250M
ICER basis
Range aggregates 3 submissions (2017–2021) — not a single base case.
Risk sharing
Risk-sharing arrangement in place — Risk-sharing arrangement proposed consisting of financial caps based on estimated net PBS/RPBS cost for venetoclax and a rebate for use beyond annual caps.

PBS expenditure

The Australian government paid $74M in PBS benefits for Venetoclax in 2024 across 12,115 scripts, at $6,118 per script.

Submission history

Similar precedents

Open on full dashboard →