PBAC's latest decision on Talimogene laherparepvec: Not recommended (2016). Considered for Treatment of unresectable stage III or stage IV malignant melanoma without visceral metastases (stage IIIb/c and stage IVM1a).
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults with unresectable stage IIIb/c or stage IVM1a (stage III or IV without visceral metastases) malignant melanoma, stratified by BRAF V600 mutation status, who have undergone surgery and have not received prior ipilimumab or PD-1 inhibitor therapy.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Durable response rate
Pivotal trial size
336 patients
Key trials
OPTiM, CA209-066, MDX010-20, KN-006, KN-001, Study 002/03
Comparator
ipilimumab (for pricing purposes); pembrolizumab, nivolumab, BRAF/MEK inhibitors, and intra-lesional BCG also considered relevant
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented but PBAC considered there was insufficient basis for it as the submission did not establish whether T-VEC was inferior or non-inferior to ipilimumab. No numeric ICER stated.
Risk sharing
Risk-sharing arrangement in place — Sponsor indicated willingness to undertake a risk sharing arrangement to account for uncertainty surrounding the average number of vials of T-VEC that will be used in clinical practice, but no details were provided.
Why PBAC said no
Reasons cited in the latest PSD: Highly uncertain magnitude of clinical benefit, highly uncertain cost-effectiveness compared to nominated comparators, insufficient basis for cost-minimisation analysis, inability to establish non-inferiority to ipilimumab, complexity of administration requiring specialist centres