PBAC's latest decision on Dupilumab: Recommended with restriction (2025). Considered for Treatment of severe atopic dermatitis in patients aged less than 12 years, and uncontrolled severe asthma in patients aged 6 to 11 years.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
13
first 2018
PBS spend
$366M
213,318 scripts · 2024
Eligible population
Paediatric patients aged less than 12 years with chronic severe atopic dermatitis, and paediatric patients aged 6 to 11 years with uncontrolled severe asthma
Therapy area
Dermatology
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Surrogate
Key trials
R668-AD-1434
Comparator
dupilumab pre-filled syringe (PFS) 200 mg in 1.14 mL and 300 mg in 2 mL
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as PFP substitutes 1:1 for PFS with estimated nil net financial impact
ICER (historical)
$15k/QALY–$25k/QALY across 3 submissions (2020–2024) — 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 — Dupilumab PFP will be subject to the same Deed arrangements that would apply for paediatric AD and uncontrolled severe asthma
PBS expenditure
The Australian government paid $366M in PBS benefits for Dupilumab in 2024 across 213,318 scripts, at $1,716 per script.
Submission history
Jul 2018: Recommended with restriction · Authority Required
Jul 2019: Recommended with restriction · Authority Required
Mar 2020: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Authority Required
Nov 2020: Noted · Restricted — ICER $55k/QALY
Mar 2022: Recommended with restriction · Authority Required
Jul 2022: Noted · Authority Required
Nov 2022: Recommended · Restricted
Jul 2023: Noted · Restricted
Nov 2023: Noted · Restricted — ICER $35k/QALY
Mar 2024: Recommended with restriction · Authority Required
Jul 2024: Not recommended · Restricted — ICER $25k/QALY
Mar 2025: Recommended with restriction · Authority Required