GUSELKUMAB

Information current as at: 1 June 2026

PBAC meeting date: July 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: Tremfya®
Form and strength:: Solution for I.V. infusion 200 mg in 20 mL vial

Injection 100 mg in 1 mL single use pre-filled pen

Injection 200 mg in 2 mL single use pre-filled pen

Injection 100 mg in 1 mL single use pre-filled syringe

Injection 200 mg in 2 mL single use pre-filled syringe
Submission sponsor:: JANSSEN-CILAG PTY LTD
Condition/indication: (therapeutic use): Severe Crohn disease (CD)
Listing requested:: To consider the sponsor's revised proposal for listing guselkumab for the treatment of adult patients with severe CD who have failed to achieve an adequate response to prior systemic therapy (i.e. corticosteroids and at least 3 months of immunosuppressive therapy). This item was previously recommended by the PBAC at its July 2025 meeting.
Funding program:: PBS General Schedule PBS Section 100 (Highly Specialised Drugs Program)
Request authority level:: Authority Required (Written)
PBAC Submission type:: New PBS listing (–)
Comment:: --
Other PBAC consideration:: --

Submission received for:: July 2026 PBAC meeting
Opportunity for consumer comment:: Open 25/03/2026 and close 20/05/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:: Has not yet commenced
7Government processes:: Has not yet commenced
8Medicine listed on the PBS:: Has not yet occurred

PBAC Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

1233

Page last updated

31 May 2026

v.9.19