script.reportAU
Neurology

Eculizumab

Brand: Soliris

PBAC's latest decision on Eculizumab: Recommended with restriction (2021). Considered for Treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) who are aquaporin-4 positive (AQP4+) with an Expanded Disability Status Scale (EDSS) score ≤ 7, and who have either frequent relapses or a prior immunosuppressive event.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
10
first 2008
Submissions
10
2008 → 2021

Eligible population

Adult patients with NMOSD who are AQP4-IgG positive with an EDSS score of 0–7 and who have had at least one relapse in the last 12 months with at least two relapses in the last 24 months, or at least two relapses in the last 12 months or three relapses in the last 24 months despite immunosuppressive therapy, or who have experienced immunosuppression-associated serious adverse events requiring treatment discontinuation.

Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Reduction in relapse frequency
Key trials
PREVENT
Comparator
best supportive care
Economic model
CUA
ICER note
ICER values are commercially sensitive and redacted in the public document. The document references redacted pricing and economic model values throughout.
ICER (historical)
$1.0M/QALY–$4.0M/QALY across 3 submissions (2008–2013) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — The resubmission included a proposal for a Risk Sharing Agreement (RSA) with an updated patient number cap, based on the total number of patients on treatment, reducing the cap compared to the first submission. A special pricing arrangement (SPA) with an effective price based on a redacted % reduction from the published price was also proposed.

Submission history

Similar precedents

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