PBAC's latest decision on Azacitidine: Recommended with restriction (2022). Considered for Maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation treatment, and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation (HSCT).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2009
Submissions
2
2009 → 2022
Eligible population
Adult patients with acute myeloid leukaemia who achieved CR or CRi following induction chemotherapy with or without consolidation treatment, and who are not candidates for or choose not to proceed to haematopoietic stem cell transplantation.
Therapy area
Haematology
Line of therapy
Maintenance
Evidence base
RCT
Primary endpoint
OS
Key trials
QUAZAR
Comparator
best supportive care (BSC) or no maintenance therapy
Economic model
CUA
ICER note
ICER value is commercially sensitive and not published in the PSD.
ICER (historical)
$45k/QALY–$75k/QALY in an earlier submission (2009) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2009: Recommended — ICER $75k/QALY
Jul 2022: Recommended with restriction · Authority Required