Vinflunine
Treatment of adult patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract (TCCU) after failure of a prior platinum-containing regimen.
Decisions on record
- Meeting Jul 2017 Not recommended Treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.
- Meeting Nov 2011 Not recommended Anti-cancer drug
Access path
- Nov 2011Not recommended
uncertainty about clinical benefit (overall survival gain less than 3 months and not statistically significant in ITT…
- Nov 2015Not recommended
Uncertain clinical benefit (OS gain less than 3 months and statistically non-significant in ITT population), high and…
- Jul 2017Not recommended
insufficient evidence of a clinical place for vinflunine, uncertain magnitude of survival gain (at best less than 3…
From the public summary
7.1 The PBAC did not recommend listing vinflunine on the PBS for the treatment of locally advanced or metastatic transitional cell carcinoma of the urothelial tract (TCCU), on the basis of lack of evidence of an incremental gain in overall survival versus currently available alternative active chemotherapy.PSD · Jul 2017
7.2 Regarding the proposed restriction, the PBAC considered, as it did in 2015, that the exclusion of patients who had received neoadjuvant or adjuvant treatment would likely exclude otherwise eligible patients who may derive a benefit from treatment with vinflunine.PSD · Jul 2017
6.22 The resubmission provided an updated trial-based economic evaluation of vinflunine versus BSC. The economic evaluation is a partitioned survival analysis based on data from Study 302. The types of economic evaluation presented were a cost- effectiveness analysis (cost per life year gained) and a cost-utility analysis (cost per quality adjusted life year gained). This is unchanged from the previous resubmission in 2015.PSD · Jul 2017
6.23 Regarding the 2015 resubmission, the PBAC was concerned that the results were highly uncertain as they were based on the mITT population rather than the ITT population (PSD, November 2015, paragraph 7.6 and 7.9).PSD · Jul 2017
6.20 The resubmission described vinflunine + BSC as superior in terms of comparative effectiveness and inferior in terms of comparative safety over BSC. The PBAC previously (PSD November 2011, Sections 9 and 12 and PSD November 2015, paragraph 7.5): ‘accepted that vinflunine is superior in terms of comparative efficacy over BSC but noted that the increment in overall survival is uncertain and, at best, is 10PSD · Jul 2017
6.21 The resubmission made no clinical claims regarding vinflunine compared to active chemotherapy. The PBAC noted the incremental effectiveness of vinflunine versus alternative active chemotherapy was unknown, but considered it likely to be insignificant.PSD · Jul 2017
6.41 The resubmission stated that it “maintained the mITT analysis as the appropriate analysis given the safeguards against inappropriate use of vinflunine proposed (e.g. authority required and financial risk share/caps)”. However no risk-sharing arrangement involving caps was detailed in the submission.PSD · Jul 2017
Cost-effectiveness
Decision context
PopulationAdult patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract who have failed a prior platinum-containing regimen, with WHO ECOG performance status of 1 or less, and who have not received neoadjuvant or adjuvant chemotherapy.
Why it was knocked back
- insufficient evidence of a clinical place for vinflunine, uncertain magnitude of survival gain (at best less than 3 months), significant toxicity burden, narrow therapeutic window, challenging realisation of benefits in clinical practice due to patient age and performance status, uncertainty regarding comparator (BSC not relevant to Australian clinical practice as vinflunine will likely replace other drugs), results based on eligible ITT population rather than ITT population introducing uncertainty
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Not recommended | best supportive care (BSC) | $45k–75k | RCT · OS |
| Nov 2015 | Not recommended | best supportive care (BSC) | — | RCT · OS |
| Nov 2011 | Not recommended | best supportive care (BSC) | $45k–75k | RCT · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO ECOG performance status ≤1 and excludes prior neoadjuvant/adjuvant chemotherapy; TGA label has no such restrictions.