PBAC's latest decision on Inotuzumab ozogamicin: Recommended with restriction (2019). Considered for Extension of listing to include relapsed or refractory Philadelphia chromosome positive (Ph+) CD22-positive B-cell precursor acute lymphocytic leukaemia (B-ALL), in addition to the previously recommended Ph-negative disease.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2018
Submissions
2
2018 → 2019
Eligible population
Adults with relapsed or refractory B-precursor cell ALL (Philadelphia chromosome positive or negative), CD22-positive, ECOG performance status ≤2, who have received intensive combination chemotherapy for initial treatment or subsequent salvage therapy, with no more than 1 line of salvage therapy, and >5% blasts in bone marrow. For Ph+ disease, patients must have previously received a tyrosine kinase inhibitor.
Therapy area
Haematology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ORR
Key trials
INO-VATE ALL
Comparator
blinatumomab; tyrosine kinase inhibitors (TKIs) for Ph+ disease
Economic model
Cost-minimisation
ICER note
Cost-minimisation basis for Ph- disease (November 2018); for Ph+ extension, PBAC was satisfied by inference that inotuzumab would be sufficiently cost-effective; no explicit ICER stated for the Ph+ population.
Risk sharing
Risk-sharing arrangement in place — Existing Risk Sharing Arrangement (RSA) in place for blinatumomab; PBAC advised that the RSA would need to be updated to include Ph+ R/R B-ALL disease with financial caps increased only by the number of additional treatment courses expected with this extension.
Submission history
Nov 2018: Recommended with restriction · Authority Required
May 2019: Recommended with restriction · Authority Required