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Oncology

Dabrafenib and trametinib

Brand: Tafinlar and Mekinist

PBAC's latest decision on Dabrafenib and trametinib: Recommended with restriction (2025). Considered for Treatment of adult patients with advanced (metastatic) Stage IV non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2015
Submissions
4
2015 → 2025

Eligible population

Adult patients with advanced (metastatic) Stage IV BRAF V600E mutation-positive non-small cell lung cancer with ECOG performance status 0-2.

Therapy area
Oncology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
93 patients
Key trials
E2201, KN-189, KN-407
Comparator
Pembrolizumab with platinum-based chemotherapy (ECOG PS 0-1); platinum-based chemotherapy alone (ECOG PS 2)
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach used; no ICER calculated by design.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2019) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

Submission history

Similar precedents

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