PBAC's latest decision on Rituximab: Recommended (2021). Considered for Biosimilar rituximab for treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and CD20-positive acute lymphoblastic leukaemia.
PBAC outcome
Recommended
Unrestricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
15
first 2006
Submissions
15
2006 → 2021
Eligible population
Patients with non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and CD20-positive acute lymphoblastic leukaemia (previously untreated or relapsed/refractory).
Therapy area
Haematology
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Key trials
B3281001, B3281006, B3281004
Comparator
Mabthera (reference biologic) and biosimilar brands Riximyo and Truxima
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission presented no economic or financial analysis beyond cost-minimisation to existing biosimilar brands.
ICER (historical)
$45k/QALY–$75k/QALY across 4 submissions (2006–2014) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2006: Recommended with restriction · Authority Required — ICER $45k/QALY
Mar 2007: Recommended with restriction · Authority required
Mar 2010: Deferred — ICER $45k/QALY
Nov 2010: Recommended with restriction · Authority Required — ICER $75k/QALY
Jul 2014: Not recommended · Authority Required — ICER $75k/QALY
Nov 2014: Recommended · Restricted
Mar 2015: Deferred · Authority Required
Jul 2015: Deferred · Authority Required
Nov 2015: Recommended with restriction · Authority Required
Mar 2017: Recommended · Restricted
Jul 2017: Recommended with restriction · Restricted
Mar 2018: Recommended · Restricted
Mar 2018: Recommended with restriction · Restricted
Mar 2019: Recommended with restriction · Authority Required