PBAC's latest decision on Sorafenib: Not recommended (2015). Considered for Treatment of locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer (RAI-R DTC).
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
8
first 2006
Submissions
8
2006 → 2015
Eligible population
Patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer who have progressed after radioactive iodine treatment.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
417 patients
Key trials
DECISION
Comparator
best supportive care (placebo)
Economic model
CUA
ICER note
ICER values are redacted (marked as '$''''''''''''''''' /QALY'). The document indicates cost-effectiveness was assessed but specific numeric values are commercial-in-confidence.
ICER (historical)
$15k/QALY–$45k/QALY across 4 submissions (2006–2013) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: ICER not reliably estimated; economic model based on uncertain overall survival data confounded by substantial crossover (71% of placebo patients crossed over); unadjusted OS did not show statistically significant improvement (HR 0.80, 95% CI 0.54–1.19); restriction did not adequately define high-risk patients aged less than 45 years as previously requested by PBAC