TEPROTUMUMAB
Information current as at: 1 June 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- Tepezza®
- Form and strength:
-
- Powder for I.V. infusion 500 mg
- Submission sponsor:
- AMGEN AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Thyroid eye disease (TED)
- Listing requested:
- To consider the sponsor's revised proposal for listing teprotumumab for the treatment of adult patients with active, moderate-to-severe TED who have a clinical activity score (CAS) or three or more for the most severely affected eye. This item was previously recommended by the PBAC at its May 2025 meeting.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Telephone/Online) for initial treatment Authority Required (STREAMLINED) for continuing treatment
- PBAC Submission type:
- New PBS listing (–)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
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 Outcome
Case ID
1242
Page last updated
31 May 2026
v.9.19