PBAC's latest decision on Dabrafenib + trametinib: Recommended with restriction (2019). Considered for Adjuvant treatment for patients with BRAF V600 mutation positive, completely resected Stage III melanoma.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2019
Submissions
1
2019 → 2019
Eligible population
Patients with completely resected Stage IIIB, IIIC or IIID melanoma with BRAF V600 positive mutations and WHO performance status of 1 or less, requiring adjuvant treatment within 12 weeks of complete resection for a maximum of 12 months.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Relapse-free survival
Key trials
COMBI-AD
Comparator
routine follow-up (clinician visits and radiological imaging)
Economic model
CUA
ICER note
ICER values are redacted in the PSD; pricing marked as commercially sensitive ('***' and 'Effective' price redacted).
Risk sharing
Risk-sharing arrangement in place — A special pricing arrangement (SPA) was proposed with an effective price reduction at the ex-manufacturer level (percentage redacted).