PBAC's latest decision on Gilteritinib: Recommended with restriction (2022). Considered for Treatment of patients with relapsed or refractory acute myeloid leukaemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$95k/QALY
Range: $75k/QALY–$95k/QALY
Submissions
2
first 2021
Submissions
2
2021 → 2022
Eligible population
Patients with relapsed or refractory acute myeloid leukaemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation, including those with ECOG status of 0 to 2.
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
248 patients
Key trials
ADMIRAL
Comparator
salvage chemotherapy (low intensity: low dose cytarabine or azacitidine; high intensity: MEC induction chemotherapy or FLAG-IDA induction chemotherapy)
Economic model
CUA
Budget impact
$15M
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement (RSA) with key elements including special pricing arrangement for gilteritinib, annual expenditure caps based on agreed net PBS/RPBS cost, and agreed rebates for exceeding the agreed annual expenditure caps.
Submission history
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required — ICER $95k/QALY