PBAC's latest decision on Adalimumab: Recommended with restriction (2024). Considered for Severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, and vision-threatening non-infectious uveitis.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
41
first 2006
PBS spend
$246M
355,511 scripts · 2024
Eligible population
Patients with severe Crohn disease, moderate to severe ulcerative colitis, severe active juvenile idiopathic arthritis, complex refractory fistulising Crohn disease, severe active rheumatoid arthritis, severe psoriatic arthritis, ankylosing spondylitis, severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, and vision-threatening non-infectious uveitis.
Therapy area
Rheumatology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Other
Pivotal trial size
465 patients
Key trials
CGPN017B12101, GP17-104, GP17-301
Comparator
Humira (reference brand) and other biosimilar brands of adalimumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation submission. No economic model presented as this is a Category 4 submission (biosimilar listing with same circumstances as reference brand).
ICER (historical)
$45k/QALY–$75k/QALY across 3 submissions (2013–2016) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $246M in PBS benefits for Adalimumab in 2024 across 355,511 scripts, at $693 per script.
Submission history
Mar 2006: Recommended with restriction · Authority Required
Nov 2006: Recommended with restriction · Authority Required
Nov 2007: Recommended with restriction · Restricted
Jul 2008: Not recommended
Mar 2009: Recommended with restriction · Authority Required
Nov 2010: Recommended with restriction · Authority Required
Mar 2013: Not recommended — ICER $45k/QALY
Nov 2013: Not recommended · Authority Required — ICER $75k/QALY
Jul 2014: Recommended with restriction · Authority Required
Nov 2014: Recommended with restriction · Restricted
Jul 2015: Recommended with restriction · Authority Required
Nov 2015: Not recommended · Authority Required
Mar 2016: Recommended with restriction · Authority Required
Mar 2016: Not recommended · Authority Required
Jul 2016: Recommended with restriction · Authority Required
Nov 2016: Recommended with restriction · Authority Required — ICER $75k/QALY
Mar 2017: Recommended with restriction · Restricted
Jul 2017: Recommended · Authority Required
Dec 2017: Recommended · Authority Required
Jul 2018: Recommended · Restricted
Jul 2018: Recommended with restriction · Restricted
Jul 2018: Recommended with restriction · Authority Required
Jul 2018: Recommended with restriction · Authority Required
Nov 2019: Recommended · Authority Required
Nov 2019: Recommended · Restricted
Mar 2020: Recommended · Authority Required
Jul 2020: Recommended with restriction · Restricted
Nov 2020: Recommended with restriction · Authority Required
Dec 2020: Not recommended · Restricted
Jul 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Authority Required
Nov 2022: Not recommended · Authority Required
Jul 2023: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required
Mar 2024: Deferred · Authority Required
Mar 2024: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required
Jul 2024: Recommended with restriction · Authority Required