EFGARTIGIMOD ALFA
Information current as at: 1 July 2026
PBAC meeting date: November 2026
Submission Details
- Brand name:
-
- Vyvgart®
- Form and strength:
-
- Injection 1000 mg in 5 mL pre-filled syringe
- Submission sponsor:
- ARGENX AUSTRALIA PTY. LTD.
- Condition/indication:
(therapeutic use) -
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Listing requested:
- Resubmission to request listing of efgartigimod alfa for the treatment of adult patients with CIDP who continue to experience significant disability or compromised walking despite an objective response to: - immunoglobulin (Ig) at the TGA-approved maintenance dose (1g/kg every 3 weeks); or - an optimised alternative non-Ig regimen consistent with European Academy of Neurology (EAN) / Peripheral Nerve Society (PNS) guidance, when unable to receive Ig due to not meeting the Blood System for Tracking Authorisations and Reviews (BloodSTAR) clinical efficacy continuation criteria, contraindication or a clinically significant intolerance.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Written or Telephone/Online)
- PBAC Submission type:
- New PBS listing (–)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - November 2026 PBAC meeting
-
2Opportunity for consumer comment:
- Open 22/07/2026 and close 16/09/2026 (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
a1275
Page last updated
23 July 2026
v.9.19