PBAC's latest decision on Siltuximab: Recommended with restriction (2021). Considered for Treatment of idiopathic multicentric Castleman disease (iMCD) in patients who are HIV-negative and HHV-8 negative.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2021
Submissions
2
2021 → 2021
Eligible population
Patients with idiopathic multicentric Castleman disease (iMCD) who are HIV-negative and HHV-8 negative, meeting international consensus diagnostic criteria for histopathologic and clinical/laboratory features.
Therapy area
Rare disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
QoL
Key trials
MCD2001, MCD2001 addendum, MCD2002
Comparator
placebo
Economic model
CUA
ICER note
ICER range redacted; stated as '$75,000 to < $95,000/QALY' in the resubmission base case at 20-year time horizon. At 15-year horizon (not requested by PBAC), ICER would also be in the same redacted range.
ICER (historical)
$75k/QALY–$95k/QALY in an earlier submission (2021) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2021: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required — ICER $95k/QALY