PBAC's latest decision on Ravulizumab: Recommended with restriction (2025). Considered for Treatment of newly diagnosed and treatment-refractory patients with generalised myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody positive and remain symptomatic despite standard therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
7
first 2020
PBS spend
$73M
1,204 scripts · 2024
Eligible population
Adult patients with generalised myasthenia gravis (not pure ocular) who are AChR antibody positive: (1) newly diagnosed (within 2 years) with MG-ADL ≥6 despite stable corticosteroids and/or non-steroidal immunosuppressants, who have failed IVIg/PLEX; or (2) treatment-refractory with ≥24 months prior immunosuppressive therapy and failed IVIg/PLEX. Patients must not be in myasthenic crisis.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Other
Comparator
placebo
Economic model
CUA
ICER note
ICER values not stated in public text. The PSD notes that the July 2024 PBAC considered the ICER presented was very high and likely underestimated, but specific numerical values are not disclosed in this resubmission document.
ICER (historical)
$455k/QALY–$555k/QALY in an earlier submission (2024) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $73M in PBS benefits for Ravulizumab in 2024 across 1,204 scripts, at $60,885 per script.
Submission history
Jul 2020: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Jul 2023: Recommended with restriction · Authority Required
Jul 2024: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required — ICER $555k/QALY
Mar 2025: Recommended with restriction · Authority Required