PBAC's latest decision on Daunorubicin with cytarabine (liposomal): Recommended with restriction (2023). Considered for Treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2023
Submissions
1
2023 → 2023
Eligible population
Adults aged 18+ years with newly diagnosed therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes, WHO performance status ≤2, without prior induction chemotherapy, and deemed unsuitable for midostaurin treatment.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
Not explicitly named in the excerpt provided, but referenced as 'the key trial'
Comparator
idarubicin and cytarabine (7+3 regimen for induction; 5+2 regimen for second induction and consolidation)
Economic model
CUA
ICER note
ICER not stated in the public summary document; economic analysis referenced but values not disclosed.