VemurafenibZelboraf

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.

The PBAC noted that the inclusion of non-health care cost in the base case analysis rather than supplementary analysis was inconsistent with the PBAC guidelines. PBAC · 2013

PopulationPreviously untreated patients with unresectable stage IIIC or stage IV (metastatic) melanoma positive for BRAF V600 mutation, with WHO performance status ≤2.

Risk sharingRisk 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.

• ICER unacceptably high and uncertain ($75,000–$105,000 per QALY without non-health care costs); uncertainty regarding BRAF test accuracy and false positives reducing cost-effectiveness; limited evidence for non-V600E mutations (27% of eligible population); modelled overall survival gain likely overestimated compared to trial results; unresolved discrepancies in utilisation and cost estimates across BRAF inhibitor submissions; need for clarification on MBS/PBS costs of BRAF testing.

Label narrower than PBS population — PBAC restricts to WHO performance status ≤2 and first-line treatment; TGA label has no performance status or line-of-therapy restrictions.