PBAC's latest decision on Obinutuzumab: Recommended with restriction (2018). Considered for Treatment of chronic lymphocytic leukaemia (CLL) in previously untreated patients with comorbidities who are inappropriate for fludarabine-based chemo-immunotherapy, in combination with chlorambucil.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
6
first 2014
PBS spend
$55M
11,748 scripts · 2024
Eligible population
Previously untreated patients with CD20-positive chronic lymphocytic leukaemia who are inappropriate for fludarabine-based chemo-immunotherapy, with creatinine clearance ≥30 mL/min and either CIRS score >6 (excluding CLL-induced illness) or creatinine clearance <70 mL/min.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
Cost-minimisation
Comparator
ofatumumab, rituximab
Economic model
Cost-minimisation
ICER note
Minor submission; no new economic evaluation required. Original ICER from March 2015 submission not stated in this PSD.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2014) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Deed of Agreement containing a Risk Sharing Arrangement in the form of a subsidisation cap above agreed use is in place for obinutuzumab.
PBS expenditure
The Australian government paid $55M in PBS benefits for Obinutuzumab in 2024 across 11,748 scripts, at $4,697 per script.
Submission history
Jul 2014: Deferred · Restricted — ICER $45k/QALY
Mar 2015: Not recommended · Restricted
Nov 2016: Recommended with restriction · Authority Required
Nov 2017: Recommended with restriction · Restricted
Mar 2018: Recommended with restriction · Restricted
Jul 2018: Recommended with restriction · Authority Required