PBAC's latest decision on Natalizumab: Recommended (2025). Considered for Treatment of clinically definite relapsing-remitting multiple sclerosis (RRMS) to delay the progression of physical disability and reduce the frequency of relapse.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
6
first 2006
Submissions
6
2006 → 2025
Eligible population
Adults with clinically definite relapsing-remitting multiple sclerosis (RRMS).
Therapy area
Neurology
Line of therapy
Any
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Comparator
Tysabri (reference biologic)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as Tyruko is a biosimilar with equivalent clinical efficacy and safety to reference product Tysabri.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (2006–2007) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2006: Not recommended · Authority Required — ICER $85k/QALY
Nov 2007: Recommended · Authority Required — ICER $75k/QALY
Jul 2019: Recommended with restriction · Restricted