PBAC's latest decision on Golimumab: Recommended with restriction (2018). Considered for Treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation (elevated CRP and/or MRI evidence) who have had an inadequate response to or are intolerant to NSAIDs.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
6
first 2010
PBS spend
$87M
76,372 scripts · 2024
Eligible population
Adults over 18 years with non-radiographic axial spondyloarthritis (defined by ASAS criteria), chronic lower back pain for ≥3 months, BASDAI ≥4, elevated CRP, sacroiliitis on MRI, who have failed to achieve adequate response to ≥2 NSAIDs for ≥3 months and have additional clinical features (enthesitis, uveitis, dactylitis, psoriasis, IBD, or HLA-B27)
Therapy area
Rheumatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ASAS 20
Key trials
GO-AHEAD
Comparator
placebo in combination with conventional care (NSAID background treatment)
Economic model
CUA
ICER note
ICER value is redacted (commercially sensitive); document states the model exists but numeric values are redacted throughout
Risk sharing
Risk-sharing arrangement in place — A revised Risk Sharing Arrangement (RSA) was proposed to address the risk of use outside the intended population and to account for uncertainty surrounding long-term cost-effectiveness; the exact terms are not detailed in this PSD
PBS expenditure
The Australian government paid $87M in PBS benefits for Golimumab in 2024 across 76,372 scripts, at $1,139 per script.
Submission history
Mar 2010: Recommended with restriction · Authority Required
Mar 2010: Recommended with restriction · Authority Required
Mar 2010: Recommended with restriction · Authority Required
Nov 2017: Recommended with restriction · Authority Required
Nov 2017: Recommended with restriction · Authority Required
Jul 2018: Recommended with restriction · Authority Required