PBAC's latest decision on Eribulin mesilate: Recommended with restriction (2013). Considered for Treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, where prior therapy should have included an anthracycline and a taxane, unless patients were not suitable for these treatments.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
2
first 2013
Submissions
2
2013 → 2013
Eligible population
Patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, with prior therapy including an anthracycline and a taxane (unless contraindicated).
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
503 patients
Key trials
EMBRACE
Comparator
vinorelbine
Economic model
CUA
ICER note
Base case ICER (extrapolated and modelled) was $15,000–$45,000/QALY; however, PBAC considered the revised ICER with adjustments (BSA distribution, vinorelbine duration, within-trial OS) of $45,000–$75,000/QALY to be the most reliable estimate. PBAC recommended listing conditional on price reduction to achieve ICER within $15,000–$45,000/QALY range.
ICER basis
Range aggregates 2 submissions (2013) — not a single base case.
Submission history
Mar 2013: Not recommended · Not applicable — ICER $75k/QALY
Nov 2013: Recommended with restriction · Authority Required — ICER $45k/QALY