PBAC's latest decision on Gemtuzumab ozogamicin: Recommended with restriction (2021). Considered for Treatment of previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, with favourable/intermediate/unknown cytogenetic risk, in combination with standard intensive chemotherapy (anthracycline and cytarabine).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2021
Submissions
2
2021 → 2021
Eligible population
Adults (age 15 years and above) with previously untreated, de novo CD33-positive acute myeloid leukaemia, except acute promyelocytic leukaemia, with favourable, intermediate, or unknown cytogenetic risk, and ECOG performance status 0–3.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
ALFA-0701
Comparator
standard intensive chemotherapy (an anthracycline and cytarabine)
Economic model
CUA
ICER note
ICER is commercially sensitive/redacted. PSD states base case ICER from previous March 2021 submission was in range $35,000 to <$45,000 per QALY, but resubmission ICER is not published.
Submission history
Mar 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required