PBAC's latest decision on Tezepelumab: Recommended with restriction (2025). Considered for Add-on maintenance treatment in patients aged 12 years and older with severe uncontrolled asthma (both eosinophilic/allergic and non-eosinophilic/non-allergic phenotypes) who are inadequately controlled despite optimal therapy including medium or high-dose inhaled corticosteroids plus another non-steroidal medicinal product for maintenance treatment.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Patients aged 12 years and older with severe uncontrolled asthma (non-eosinophilic/non-allergic or eosinophilic/allergic phenotypes) inadequately controlled despite optimised high-dose inhaled corticosteroid plus long-acting beta-2 agonist therapy.
Therapy area
Respiratory
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
AAER
Comparator
Standard of care for non-eosinophilic/non-allergic SUA; dupilumab for eosinophilic/allergic SUA
Economic model
CUA
ICER note
ICER values redacted (commercially sensitive) for non-eosinophilic/non-allergic population; cost-minimisation approach used for eosinophilic/allergic population versus dupilumab.