PBAC's latest decision on Vinflunine: Not recommended (2017). Considered for 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.
PBAC outcome
Not recommended
2017
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 2 submissions
Submissions
3
first 2011
Submissions
3
2011 → 2017
Eligible population
Adult 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.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
370 patients
Key trials
Study 302
Comparator
best supportive care (BSC)
Economic model
CUA
ICER basis
Range aggregates 2 submissions (2011–2017) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: 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
Nov 2011: Not recommended · Authority Required — ICER $75k/QALY