EFGARTIGIMOD ALFA
Information current as at: 1 July 2026
The pharmaceutical company has not advised whether they intend to proceed or not within 60 days of receiving the ratified PBAC minutes. The process for listing is considered inactive.
Submission Details
- Brand name:
-
- Vyvgart®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- ARGENX AUSTRALIA PTY. LTD.
- Condition/indication:
(therapeutic use) -
- Generalised myasthenia gravis (gMG)
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Change to listing (Category 4)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
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
The PBAC recommended efgartigimod alfa (EFG) 1000 mg / 5.0 mL pre filled syringe (PFS), for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive. The PBAC welcomed input from a health care professional and organisation that highlighted the significant and ongoing burden of symptoms that people with gMG experience.
The PBAC recommended EFG PFS as a section 100 (Highly Specialised Drug) Authority Required (Written/Online) listing. The PBAC considered that a claim of non inferior effectiveness and non inferior comparative safety of EFG PFS versus EFG SC and EFG IV was reasonable, and noted that there was no data to establish clinical superiority and a higher price of EFG PFS over other therapies recommended for gMG at the March 2025 and November 2025 PBAC meetings (ravulizumab, rozanolixizumab and zilucoplan). The PBAC recommended EFG PFS on the basis that it be priced as per the other gMG medicines recommended (and noting that 1 vial EFG PFS should be priced equivalent to 1 vial EFG SC or 2.4 vials of EFG IV). The PBAC advised that EFG PFS should also enter into the Risk Sharing Arrangement for these previously recommended gMG medicines.