PBAC's latest decision on Lanadelumab: Recommended with restriction (2024). Considered for Preventative treatment of hereditary angioedema (HAE) Types 1 or 2 in patients aged 2 to 11 years who have experienced at least one treated acute attack within a three-month period.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2019
Submissions
4
2019 → 2024
Eligible population
Patients diagnosed with HAE Types 1 or 2 aged 2 to 11 years who experienced at least one treated acute attack within a three-month period prior to commencing treatment.
Therapy area
Immunology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
HAE attack rate
Pivotal trial size
21 patients
Key trials
SPRING
Comparator
on-demand treatment (icatibant or C1 esterase inhibitor)
Economic model
Not modelled
ICER note
No economic evaluation presented in submission; cost-effectiveness cannot be quantified.
Submission history
Jul 2019: Recommended with restriction · Authority Required
Jul 2020: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required