PBAC's latest decision on Asciminib: Recommended with restriction (2022). Considered for Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase who have been previously treated with two or more tyrosine kinase inhibitors, or who have the T315I mutation and have been previously treated with one or more tyrosine kinase inhibitors.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2022
Submissions
2
2022 → 2022
Eligible population
Adult patients with Ph+ CML in chronic phase: (i) previously treated with two or more TKIs; or (ii) with T315I mutation previously treated with one or more TKIs (imatinib, dasatinib, or nilotinib)
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
MMR, CCyR
Key trials
ASCEMBL, CABL001X2101, PACE
Comparator
Nilotinib (main comparator for non-T315I patients); Ponatinib (supplementary comparator for T315I patients)
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis; no ICER calculated. PBAC noted the economic evaluation should reflect benchmarking against second generation TKIs (nilotinib and dasatinib) based on equi-effective doses.
Submission history
Jul 2022: Recommended with restriction · Authority Required
Nov 2022: Recommended with restriction · Authority Required