PBAC's latest decision on Fingolimod: Recommended with restriction (2019). Considered for Treatment of relapsing-remitting multiple sclerosis (RRMS) in paediatric and adolescent patients weighing 40 kg or less.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2011
Submissions
2
2011 → 2019
Eligible population
Paediatric and adolescent patients aged 10 to less than 18 years with clinically definite relapsing-remitting multiple sclerosis weighing 40 kg or less.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
107 patients
Key trials
Study 2311
Comparator
fingolimod 500 mcg capsule
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. PBAC considered equivalent efficacy and safety to fingolimod 500 mcg, priced the same.
ICER (historical)
$45k/QALY–$75k/QALY in an earlier submission (2011) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2011: Recommended · Authority Required — ICER $75k/QALY
Jul 2019: Recommended with restriction · Authority Required