PBAC's latest decision on Vemurafenib + cobimetinib: Recommended with restriction (2016). Considered for Treatment of BRAF V600 mutation positive unresectable or metastatic melanoma as first-line therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults with previously untreated BRAF V600 mutation positive unresectable Stage III or Stage IV metastatic melanoma, with WHO performance status of 2 or less, not previously treated with PBS subsidised BRAF inhibitor therapy or with documented intolerance to another BRAF inhibitor.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
1,030 patients
Key trials
coBRIM, COMBI-D, COMBI-V
Comparator
dabrafenib + trametinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Risk sharing
Risk-sharing arrangement in place — Risk Share Arrangement (RSA) with dabrafenib + trametinib sponsor required to ensure no additional cost to Government beyond current financial caps.