script.reportAU
Oncology

Encorafenib; binimetinib

Brand: Braftovi®; Mektovi®

PBAC's latest decision on Encorafenib; binimetinib: Recommended with restriction (2018). Considered for Treatment of unresectable or metastatic melanoma with a BRAF V600 mutation. The combination is indicated for adult patients with unresectable Stage III or Stage IV malignant melanoma positive for BRAF V600 mutation.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2018
Submissions
1
2018 → 2018

Eligible population

Adult patients with unresectable Stage III or Stage IV malignant melanoma with BRAF V600 mutation, WHO performance status 0–2, treatment-naïve or intolerant to another BRAF inhibitor.

Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
577 patients
Key trials
COLUMBUS, COMBI-V, COMBI-D, coBRIM
Comparator
dabrafenib+trametinib (primary); vemurafenib+cobimetinib (secondary)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated as equi-effectiveness was demonstrated.
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement (RSA) currently in place for the comparators (dabrafenib+trametinib and vemurafenib+cobimetinib); special pricing arrangements apply to encorafenib and binimetinib.

Similar precedents

Open on full dashboard →