PBAC's latest decision on Alectinib: Recommended with restriction (2025). Considered for Adjuvant treatment in adult patients following tumour resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥4 cm or node positive).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2017
Submissions
3
2017 → 2025
Eligible population
Adult patients with resected ALK-positive NSCLC (tumours ≥4 cm or node positive) following tumour resection, with WHO performance status ≤1.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
DFS
Key trials
ALINA
Comparator
platinum-based chemotherapy
Eligible patients/year
82
ICER note
No ICER values are stated in the public summary document.
Submission history
Jul 2017: Recommended with restriction · Authority Required
Mar 2019: Not recommended · Restricted
May 2025: Recommended with restriction · Authority Required