PBAC's latest decision on Trametinib: Recommended with restriction (2016). Considered for Treatment of unresectable or metastatic melanoma in patients with BRAF V600 mutation, in combination with dabrafenib or as monotherapy in patients with intolerance to BRAF inhibitors.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 2 submissions
Submissions
3
first 2014
Submissions
3
2014 → 2016
Eligible population
Adults with unresectable stage III or metastatic (stage IV) BRAF V600 mutation-positive melanoma, in combination with dabrafenib, or as monotherapy in patients with intolerance to BRAF inhibitors.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
1,739 patients
Key trials
BRF113220, COMBI-D, COMBI-V
Comparator
dabrafenib monotherapy
Economic model
CUA
ICER basis
Range aggregates 2 submissions (2014–2016) — not a single base case.
Risk sharing
Risk-sharing arrangement in place — Managed Entry Scheme (MES) with rebate arrangement: if the clinical benefit of trametinib modelled from BRF113220 fails to be realised in final COMBI-D and COMBI-V results, sponsor rebates Commonwealth by price reduction multiplied by script numbers between listing and price reduction date, with interest applied.
Submission history
Mar 2014: Not recommended · Authority Required
Nov 2014: Recommended with restriction · Authority Required — ICER $75k/QALY