GUSELKUMAB

Brand name:

• Tremfya®

Form and strength:

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

Submission sponsor:

JANSSEN-CILAG PTY LTD

Condition/indication:
(therapeutic use)

• Chronic plaque psoriasis (CPP)

Listing requested:

To request a General Schedule Authority Required (Written) listing for the treatment of severe CPP.

Funding program:

PBS General Schedule

Request authority level:

Authority Required

PBAC Submission type:

Change to existing listing (Matters arising/Matters outstanding)

Comment:

Special Out of Session July 2026 PBAC Meeting

Other PBAC consideration:

• GUSELKUMAB

Submission received for:

November 2026 PBAC meeting

Opportunity for consumer comment:

--

3PBAC meeting:

Has not yet occurred

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

10/09/2026

Lodgement of required documentation:

18/09/2026

Acceptance of complete documentation:

Accepted

6Agreement to listing arrangements:

Commenced on 30/09/2026

Status:

Under consideration

7Government processes:

Has not yet commenced

8Medicine listed on the PBS:

Has not yet occurred