PBAC's latest decision on Lorlatinib: Deferred (2021). Considered for Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) with evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2019
Submissions
3
2019 → 2021
Eligible population
Patients with locally advanced (Stage IIIB) or metastatic (Stage IV) ALK-positive non-small cell lung cancer (non-squamous or not otherwise specified type) who have not previously been treated with an ALK tyrosine kinase inhibitor (TKI), with WHO performance status of 2 or less.
Therapy area
Oncology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
296 patients
Key trials
CROWN, ALEX, ALTA-1L
Comparator
alectinib (main); brigatinib (supplementary)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis submitted; no ICER calculated or stated.
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement anticipated; RSA currently in place for lorlatinib, alectinib and brigatinib.
Submission history
Nov 2019: Recommended with restriction · Authority Required