Efgartigimod AlfaVYVGART
Treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Mar 2026 Recommended Generalised myasthenia gravis (gMG) with anti-acetylcholine receptor (AChR) antibody positive
- Meeting Mar 2026 Not recommended Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Meeting Nov 2025 Recommended Generalised myasthenia gravis in anti-acetylcholine receptor antibody positive patients
- Meeting Mar 2025 Recommended Generalised myasthenia gravis (gMG), anti-acetylcholine receptor antibody positive
Access path
- TGA registered · VYVGART
TGA label equal than the PBS population
- Mar 2025Recommended · restricted
vs chronic intravenous immunoglobulin (IVIg)
- Nov 2025Recommended · restricted
Comparator changed: chronic intravenous immunoglobulin (IVIg) → efgartigimod alfa…
- Mar 2026Recommended · restricted
Comparator changed: efgartigimod alfa intravenous (EFG IV) 400 mg/20 mL → efgartigimod…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of efgartigimod alfa pre-filled syringe for the treatment of generalised myasthenia gravis (gMG), on the basis that it should be available only under special arrangements under the section 100 Highly Specialised Drug program (s100 HSD) as an Authority Required (Written/Online) listing. The PBAC advised that the requested section 85 general schedule listing would be inappropriate 7 OFFICIALPSD · Mar 2026
OFFICIAL Public Summary Document – March 2026 PBAC Meeting and recommended a s100 HSD listing, consistent with its recommendations in March and November 2025 for other novel gMG medicines.PSD · Mar 2026
5.15 The submission presented a CMA of EFG PFS compared to SC, assuming a 1:1 substitution and requesting the same price per unit. The sponsor stated that as a simplifying assumption, it was assumed that EFG is the only treatment listed for gMG on the PBS and therefore that all potential patients would use EFG to the exclusion of all other therapies.PSD · Mar 2026
5.16 The proposed equi-effective dose is 1x1000 mg/5.6 mL SC = 1x1000 mg/5.0 mL PFS.PSD · Mar 2026
5.11 Clinical effectiveness and safety non-inferiority has previously been established between EFG IV/SC, other FcRn and complement-based therapies and chronic IVIg.PSD · Mar 2026
5.12 The submission claimed bioequivalence between EFG SC and PFS. The TGA evaluation leveraged the EMA assessment report via the TGA Comparable Overseas Regulator (COR-B) pathway, as such, the TGA have accepted the EMA conclusion that EFG PFS is bioequivalent to EFG SC.PSD · Mar 2026
6.4 Advice from MAA stated its aim is for each patient to have equitable and timely access to the best available treatment that most benefits them. MAA supported access to the new therapies across the disease severities and settings including early, upfront access and also in patients with refractory disease, noting that refractory patients have a higher unmet need. MAA strongly supported access to a broad range of treatment options.PSD · Mar 2025
This does not include pyridostigmine or other cholinesterase inhibitors. d) Patients should either have had an adequate dose AND duration of these two other therapies, perhaps one year; OR be taking an adequate dose of these two other therapies without requiring a set duration AND have failed a loading course of IVIg or plasma exchange.PSD · Mar 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as PFS and SC are claimed bioequivalent at same price
The submission presented a CMA of EFG PFS compared to SC, assuming a 1:1 substitution and requesting the same price per unit. PSD · 2026
Decision context
PopulationAdult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive
Risk sharingEFG PFS should join the Risk Sharing Arrangement for gMG medicines recommended in March 2025, to mitigate risks of use outside intended restrictions and increase in frequency of cycles over time
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | efgartigimod alfa subcutaneous and intravenous formulations | — | Single-arm |
| Nov 2025 | Recommended · restricted | efgartigimod alfa intravenous (EFG IV) 400 mg/20 mL | — | RCT · Surrogate |
| Mar 2025 | Recommended · restricted | chronic intravenous immunoglobulin (IVIg) | $1.05m | RCT · PFS |
Consumer voice
Consumers and healthcare professionals highlighted the significant unmet need for new gMG therapies, emphasizing the substantial impact on quality of life, daily functioning, and financial burden. They noted efficacy and rapid onset of efgartigimod, with particular emphasis on the importance of flexible administration modes and equitable access across disease severities.
The comments described the high unmet need for new therapies to treat gMG. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe identical population: adult gMG patients with anti-AChR antibody positivity receiving add-on to standard therapy.