PBAC's latest decision on Vinorelbine: Not recommended (2012). Considered for For the treatment of advanced breast cancer after failure of standard prior therapy, as a single agent or in combination. Also for locally advanced or metastatic non-small cell lung cancer.
PBAC outcome
Not recommended
Authority Required (STREAMLINED)
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2012
Submissions
1
2012 → 2012
Eligible population
patients with advanced breast cancer after failure of standard prior therapy, as a single agent or in combination. Also for locally advanced or metastatic non-small cell lung cancer.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT | Single-arm
Primary endpoint
OS | PFS
Key trials
CA-221, CA-222
Comparator
intravenous (IV) vinorelbine
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented but not accepted by PBAC due to rejection of efficacy claim and concerns about pricing methodology
Why PBAC said no
Reasons cited in the latest PSD: inadequate evidence to support claim of equivalence in comparative effectiveness and safety between oral and IV vinorelbine, inappropriate cost-minimisation analysis, results of CA-221 showed oral vinorelbine associated with lower response rates and shorter PFS/OS than IV vinorelbine, limited data for trastuzumab combination, no clinical evidence for removal of anthracycline requirement, uncertainty in patient number estimates, dosing assumptions not supported by clinical guidelines