PBAC's latest decision on Larotrectinib: Not recommended (2024). Considered for Treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) or soft tissue sarcoma (STS) harbouring neurotrophic tropomyosin receptor kinase (NTRK) gene fusions.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2020
Submissions
4
2020 → 2024
Eligible population
Adults with locally advanced or metastatic NSCLC or STS harbouring confirmed NTRK gene fusions.
Therapy area
Oncology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
55 patients
Comparator
docetaxel (NSCLC); pazopanib (STS)
Economic model
CUA
ICER note
ICERs exceeded $95,000 to <$115,000/QALY gained; specific numeric values not stated in public text.
Why PBAC said no
Reasons cited in the latest PSD: small patient numbers across studies (NSCLC n=25, STS n=30), immature overall survival data, evidence restricted to refractory setting not applicable to proposed line-agnostic listing, concerns about standard of care comparators and their applicability to early-line setting, claim of superiority based on descriptive indirect comparisons not sufficiently supported, high and uncertain ICER
Submission history
Nov 2020: Recommended with restriction · Restricted
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required