script.reportAU
Dermatology

Dupilumab

Brand: Dupixent

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

Similar precedents

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