EribulinERIBULIN DR. REDDY'S
Advanced or metastatic liposarcoma in patients who have failed prior chemotherapy, including an anthracycline.
Decision on record
- Meeting Nov 2016 Recommended Soft tissue sarcoma
Access path
- TGA registered · ERIBULIN DR. REDDY'S
TGA label narrower than the PBS population
- Nov 2016Recommended · restricted
vs dacarbazine
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of eribulin, on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy – Public and Private Hospital).PSD · Nov 2016
7.2 The PBAC is satisfied that eribulin provides, for some patients, a significant improvement in efficacy over dacarbazine.PSD · Nov 2016
6.30 The submission presented a modelled economic analysis comparing eribulin and dacarbazine (main comparator). This was consistent with the clinical evidence. The submission did not consider ifosfamide as a supplementary comparator for the economic evaluation. A summary of the model structure and rationale is presented in Table 7.PSD · Nov 2016
Table 7: Summary of model structure and rationale Component Summary The submission stated that the model had a 5 year time horizon, however the economic model was a trial-based analysis whereby the full Kaplan-Meier curves for OS from the liposarcoma subgroup were applied. In the model it was assumed that all patients died in Time horizon the cycle following the end of the curves.PSD · Nov 2016
6.24 The submission described eribulin as superior in terms of comparative effectiveness and different in terms of comparative safety over dacarbazine.PSD · Nov 2016
6.25 The claim of different safety compared with dacarbazine was not adequately supported. A more appropriate claim would be that eribulin is inferior to dacarbazine in terms of comparative safety for the treatment of patients with locally unresectable or metastatic soft tissue sarcoma, as: the proportion of patients with Grade 3 or 4 TEAEs was significantly higher with eribulin; eribulin was associated with statistically significant higher rates of …PSD · Nov 2016
6.2 The PBAC noted the letter of support received from Rare Cancers Australia for the eribulin submission. Rare Cancers Australia stated that, based on anecdotal experience, outcomes for liposarcoma are often poor, treatment options are limited and there is a high unmet clinical need for additional therapies.PSD · Nov 2016
6.54 The submission proposed a special pricing arrangement similar to the current arrangement for use in patients with breast cancer. In the Pre-PBAC response, the sponsor indicated a willingness to negotiate a risk sharing arrangement to mitigate additional concerns raised by the PBAC.PSD · Nov 2016
Cost-effectiveness
ICER values are redacted (denoted as '''''' in the price schedule).
The PBAC noted that Study 309 was not powered to identify a difference in survival across the treatment arms for the liposarcoma subgroup, and that results require caution in interpretation. PBAC · 2016
Decision context
PopulationAdults aged 18 years or older with advanced (unresectable and/or metastatic) liposarcoma (myxoid, pleomorphic, dedifferentiated, or round cell subtypes) who have received prior chemotherapy including an anthracycline, with WHO ECOG performance status of 2 or less.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended · restricted | dacarbazine | — | RCT · OS |
Consumer voice
Rare Cancers Australia expressed support for eribulin, noting poor outcomes for liposarcoma, limited treatment options, and a high unmet clinical need for additional therapies based on anecdotal experience.
outcomes for liposarcoma are often poor, treatment options are limited and there is a high unmet clinical need for additional therapies Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to anthracycline-pretreated patients, specific histological subtypes, ECOG ≤2, and second-line use; TGA label has no these restrictions.