EFGARTIGIMOD ALFA
Information current as at: 1 July 2026
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) -
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- 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 existing listing (Category 1)
- 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: - Not Recommended (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
The PBAC did not recommend efgartigimod alfa (Vyvgart®) for the treatment active chronic inflammatory demyelinating polyneuropathy (CIDP) in patients whose symptoms continue despite treatment with blood products such as immunoglobulin and for those who cannot tolerate immunoglobulin. CIDP is a chronic autoimmune nerve disorder.
The PBAC acknowledged the consumer input received and considered that there is a high unmet need for additional treatment options for people with CIDP. However, the PBAC was not satisfied that the available evidence clearly demonstrated which patients should receive efgartigimod in clinical practice, nor how patients would be safely switched from immunoglobulin treatment to efgartigimod alfa.
As the clinical benefits compared with immunoglobulin treatment were uncertain, the PBAC considered that the economic analysis and high estimated cost to the public did not provide enough certainty or information for decision making.