PBAC's latest decision on Ceritinib: Recommended with restriction (2016). Considered for Treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on a prior ALK inhibitor (ALKi).
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adult patients with ALK-positive locally advanced or metastatic NSCLC who have progressed on or are intolerant of crizotinib, with WHO performance status ≤2.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
231 patients
Key trials
ASCEND-5
Comparator
platinum doublet chemotherapy (carboplatin or cisplatin with gemcitabine) followed by pemetrexed maintenance
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis submitted; no ICER calculated.