Eribulin MesilateERIBULIN DR. REDDY'S
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.
Decision on record
- Meeting Nov 2013 Recommended 1 mg/2 mL, injection, vial Halaven® Eisai Australia Pty Ltd Major submission Breast cancer Resubmission to request Section 100 (Efficient Funding of Chemotherapy) Authority Required (+/-STREAMLINED) listings for the treatment of a patient with locally advanced or metastatic breast cancer who has pro
Access path
- TGA registered · ERIBULIN DR. REDDY'S
TGA label equal than the PBS population
- Mar 2013Not recommended
unacceptably high and uncertain cost-effectiveness, lack of clarity regarding clinical place of the product, uncertain…
- ↻ resubmittedNov 2013Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- PBS listing · Authority Required
From the public summary
7. Clinical Trials The primary and supporting trials were unchanged from the previous submission, with the major exception of additional analysis relating to the primary trial (EMBRACE), including complete overall survival (OS) data on a larger proportion of patients. These data were introduced in the pre-subcommittee response (PSCR) to the previous submission, and were described in more detail in the resubmission.PSD · Nov 2013
The PBAC considered the selection and interpretation of primary and supporting trials to be appropriate.PSD · Nov 2013
Cost-effectiveness
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.
From the results of the economic analysis, the PBAC considered the ICER presented in the PSCR (verified by the Evaluators) based on the OS results observed in the updated data for the comparison versus TPC of between $45,000 and $75,000 per LYG to be unacceptably high and uncertain. PBAC · 2013
Decision context
PopulationPatients 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).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | vinorelbine | $15k–45k | RCT · OS |
| Mar 2013 | Not recommended | Treatment of Physician's Choice (TPC) | $45k–75k | RCT · OS |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify identical patient populations: locally advanced/metastatic breast cancer after ≥2 prior regimens including anthracycline and taxane unless unsuitable.