PBAC's latest decision on Certolizumab pegol: Recommended with restriction (2019). Considered for Treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation (elevated C-reactive protein and MRI evidence) who have had inadequate response to or are intolerant to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
8
first 2010
Submissions
8
2010 → 2019
Eligible population
Adults aged 18 years or older with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (elevated CRP and MRI evidence of sacroiliitis with bone marrow oedema), who have failed at least 2 NSAIDs for 3 months, have BASDAI ≥4 and CRP >10 mg/L, and meet ASAS classification criteria.
Therapy area
Rheumatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ASDAS-MI and ASAS40
Pivotal trial size
317 patients
Key trials
AS0006, AS001, GO-AHEAD
Comparator
golimumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Risk sharing
Risk-sharing arrangement in place — PBS listing of the comparator golimumab is currently subject to a Risk Sharing Arrangement (RSA).
Submission history
Mar 2010: Recommended · Authority Required
Mar 2014: Recommended with restriction · Authority Required
Nov 2014: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Restricted
Mar 2017: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Authority Required