Vinorelbine TartrateNavelbine IV
Recommended OncologyAuthority RequiredFirst-line line
Locally advanced or metastatic non-small cell lung cancer (NSCLC) as first-line treatment.
2
Submissions
2006–06
On the record
—
ICER range
Cost-min
Cost basis
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
- Mar 2006Recommended · restricted
Evidence: RCT, Single-arm → RCT
- Mar 2006Recommended · restricted
Evidence: RCT, Single-arm → RCT
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered that this cost was overestimated and would need to be adjusted. PBAC · 2006
Economic model disputed
Decision context
PopulationPreviously untreated patients with stage IIIB or IV NSCLC, good performance status.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2006 | Recommended · restricted | intravenous vinorelbine | — | RCT, Single-arm · ORR, PFS, OS |
| Mar 2006 | Recommended · restricted | intravenous vinorelbine | — | RCT · ORR |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to locally advanced or metastatic disease; TGA label includes first-line treatment without disease stage specification.