PBAC's latest decision on Brigatinib: Noted (2019). Considered for Locally advanced (Stage IIIB) or metastatic (Stage IV) anaplastic lymphoma kinase (ALK)-positive non-squamous or not otherwise specified non-small cell lung cancer (NSCLC) in patients with WHO performance status of 2 or less.
PBAC outcome
Noted
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2019
Submissions
1
2019 → 2019
Eligible population
Adults with locally advanced (Stage IIIB) or metastatic (Stage IV) ALK-positive non-squamous or not otherwise specified NSCLC with WHO performance status of 2 or less, including both treatment-naïve patients and those previously treated with crizotinib.
Therapy area
Oncology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
275 patients
Key trials
ALTA-1L, ALEX, Study 201-ALTA, ALUR
Comparator
alectinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis (CMA) was presented; no ICER was calculated as the submission claimed non-inferiority on efficacy and safety basis.