PBAC's latest decision on Dabrafenib: Recommended (2013). Considered for Treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 2 submissions
Submissions
2
first 2013
Submissions
2
2013 → 2013
Eligible population
Patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma who are previously untreated.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Key trials
BREAK-3
Economic model
CUA
ICER basis
Range aggregates 2 submissions (2013) — not a single base case.
Risk sharing
Risk-sharing arrangement in place — A risk-sharing arrangement was proposed to deal with the financial risk of use of dabrafenib beyond progression through a cap.
Submission history
Mar 2013: Deferred · Authority Required — ICER $105k/QALY