PBAC's latest decision on Vemurafenib: Deferred (2013). Considered for Treatment of BRAF V600 mutation-positive patients with unresectable (stage IIIC) or metastatic (stage IV) melanoma with WHO performance status ≤2.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
$105k/QALY
$75k/QALY–$105k/QALY · across 2 submissions
Submissions
2
first 2012
Submissions
2
2012 → 2013
Eligible population
Previously untreated patients with unresectable stage IIIC or stage IV (metastatic) melanoma positive for BRAF V600 mutation, with WHO performance status ≤2.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
BRIM 3
Comparator
dacarbazine (DTIC)
Economic model
CUA
Budget impact
$45M
Eligible patients/year
10,000
ICER note
Base case ICER range of $75,000–$105,000 per QALY (without non-health care costs). With rebate and non-health care costs included, ICER was $45,000–$75,000, but PBAC noted inclusion of non-health care costs in base case was inconsistent with PBAC guidelines.
ICER basis
Range aggregates 2 submissions (2012–2013) — not a single base case.
Risk sharing
Risk-sharing arrangement in place — Risk share arrangement proposed to reduce estimated net cost to PBS; arrangement intended to verify anticipated overall survival benefits and manage risk of continued therapy beyond disease progression.
Submission history
Jul 2012: Deferred — ICER $200k/QALY
Mar 2013: Deferred · Authority Required — ICER $105k/QALY