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 EFG SC for the treatment of gMG under the same circumstances as EFG IV based on a cost comparison to IVIg, as per EFG IV which was recommended in March 2025. The PBAC advised that a general schedule (s85) listing would be inappropriate and recommended that EFG SC be listed as a Section 100 (Highly Specialised Drug) Authority Required (Written/Online) listing, consistent with its recommendation for EFG IV and other …PSD · Nov 2025
6.2 The PBAC considered that the clinical claim of non-inferior effectiveness and non- inferior safety of EFG SC versus EFG IV was reasonable, noting the clinical data provided, along with the opinion of the TGA and EMA that the SC and IV forms are therapeutically equivalent.PSD · Nov 2025
5.11 The submission presented a cost-minimisation approach of EFG SC compared with EFG IV. The cost minimisation was set over the course of one year of treatment and used the same average number of cycles as recommended in March 2025, 4.72 cycles per year. Both EFG SC and EFG IV are administered in a cycle of 4 weeks of treatment, followed by 4 weeks of no treatment.PSD · Nov 2025
5.12 The proposed equi-effective dose is one vial of EFG SC 1000 mg/5.6 mL = 2.4 vials of EFG IV 400 mg/20 mL infusion. This equated to an annual dose of EFG SC of 18,880 mg per patient per year. 5PSD · Nov 2025
5.9 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of EFG SC compared with EFG IV.PSD · Nov 2025
5.10 The TGA and EMA have found EFG SC and EFG IV to be therapeutically equivalent.PSD · Nov 2025
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) | — | 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.