script.reportAU
Gastroenterology

Guselkumab

Brand: Tremfya

PBAC's latest decision on Guselkumab: Recommended with restriction (2025). Considered for Treatment of adults with severe Crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
6
first 2018
PBS spend
$149M
39,868 scripts · 2024

Eligible population

Adults aged 18 years or older with severe Crohn's disease (CDAI ≥300 or CDAI ≥220 with extensive small intestine disease) who have failed prior systemic therapy (corticosteroids and at least 3 months of immunosuppressive therapy) and have evidence of intestinal inflammation or high faecal output or require surgery or total parenteral nutrition.

Therapy area
Gastroenterology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Clinical response and clinical remission
Key trials
GALAXI trials, UNITI-1, UNITI-2, CERTIFI, U-EXCEED, U-ENDURE
Comparator
adalimumab, infliximab, upadacitinib, ustekinumab, vedolizumab
Economic model
CUA
ICER note
ICER values are redacted (marked as &&&&) in the publicly available document; commercial-in-confidence pricing and economic model details are not disclosed.

PBS expenditure

The Australian government paid $149M in PBS benefits for Guselkumab in 2024 across 39,868 scripts, at $3,725 per script.

Submission history

Similar precedents

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