VinorelbineNavelbine IV
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.
Decisions on record
- Meeting Nov 2014 Recommended The Medical Oncology Group of Australia on behalf of various sponsors Change to listing (Correspondence) Cancer The Medical Oncology Group of Australia sought to have the drugs capecitabine, megestrol, toremifene and vinorelbine (injection presentation only) made available as unrestricted pharmaceut
- Meeting Nov 2012 Not recommended Breast cancer
Access path
- TGA registered · Navelbine IV
TGA label narrower than the PBS population
- Nov 2012Not recommended
inadequate evidence to support claim of equivalence in comparative effectiveness and safety between oral and IV…
Cost-effectiveness
Cost-minimisation analysis presented but not accepted by PBAC due to rejection of efficacy claim and concerns about pricing methodology
The PBAC considered that the data presented from CA-221 and CA-222 did not adequately support the claim of equivalence in terms of comparative effectiveness and comparative safety of oral and IV vinorelbine. PBAC · 2012
Decision context
Populationpatients 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.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2012 | Not recommended | intravenous (IV) vinorelbine | — | RCT | Single-arm · OS | PFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line treatment; TGA label permits single agent or combination without line-of-therapy specification.