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pCODR Reimbursement Decision




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  Halaven
Generic Name Eribulin Mesylate
Manufacturer Eisai Limited
pCODR Indication Metastatic Breast Cancer
pCODR Tumour Type Breast
Funding Request For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.
Submission Date 2012-02-09
Submission Type New Drug
Review Status Notification to Implement Issued
Recommendation Date 2012-08-02
Notification to Implement Date 2012-08-20
RD Interpretation of pERC Recommendation Recommended - conditional on improved cost-effectiveness.
pERC Recommendation

The pCODR Expert Review Committee (pERC) recommends funding eribulin (Halaven) in patients with metastatic or incurable locally advanced breast cancer conditional on its cost-effectiveness being improved to an acceptable level. It should be funded for patients who have had previous treatment with a taxane and an antracycline, who have had at least two chemotherapy regimens for metastatic or locally recurrent disease and who have progressed after their last therapy. In addition, patients must have good performance status (ECOG ≤ 2). The Committee made this recommendation because they were satisfied that there was an overall clinical benefit for eribulin compared with standard therapies. However, at either the list price or the the submitted price, the Economic Guidance Panel’s estimates of the incremental cost-effectiveness ratio for eribulin could not be considered cost-effective comapred with current therapies.

Patient Population

Patients with metastatic or incurable locally advanced breast cancer, patients who have had previous treatment with a taxane and an anthracycline, who have had at least two chemotherapy regimens for metastatic or locally recurrent disease and who have progressed after their last therapy. In addition, patients must have good performance status (ECOG >= 2)

RD Interpretation of Patient Population Requested vs Actual

Same

Summary of pERC Deliberations - Clinical

pERC deliberated upon the results of the EMBRACE study, which evaluated eribulin compared with a treatment of physician's choice and concluded that there is a net clinical benefit associated with eribulin. pERC noted that there was a modest but clinically and statistically significant improvement in the overall survival. The observation of a survival advantage was particularly important in this heavily pre-treated population with advanced disease, because there is a lack of evidence supporting a survival benefit of currently available treatment options. Overall, pERC considered the quality of the clinical trial to be reasonable; however, some limitations in the trial design were noted, particularly the lack of quality of life data. While blinding would have been impractical due to the variety of treatment options used in the comparator arm, pERC noted that the open-label nature of the trial may have introduced bias into the study results. In addition, pERC noted that there was uncertainty in the dose intensity of the comparator arm and it was unclear how this might have impacted the use of supportive therapies and overall survival results.

Summary of pERC Deliberations - Safety

pERC also reviewed the safety data for eribulin and noted that serious adverse events were similar between the two treatment groups. pERC discussed that peripheral neuropathy and febrile neutropenia were higher with eribulin compared with the treatment of physician's choice arm. However, pERC noted that these adverse events are commonly observed with other standard chemotherapeutic agents and considered that the toxicity profile of eribulin was acceptable.

Summary of pERC Deliberations - Cost-effectiveness

pERC discussed that one of the main factors affecting the cost-effectiveness estimates was the survival estimates used in the economic model. In reviewing the clinical data from the EMBRACE trial, pERC noted that while all of the survival benefit in the trial is observed by 18 to 24 months, in the submitted economic model, approximately 60% of the survival benefit of eribulin is based on extrapolated data beyond 18 months. Based on the planned survival analysis from the EMBRACE study, there was no evidence that benefit would accumulate past 24 months. Therefore, pERC considered that the cost-effectiveness of eribulin compared with treatment of physician’s choice is likely between $223,840 per QALY and $272,275 per QALY, depending on when the expected cumulative survival benefit stops accruing between 18 and 24 months. As a result, pERC did not consider eribulin to be cost-effective. pERC considered feedback from the manufacturer that survival benefit data beyond 18 months from the EMBRACE trial were not incorporated into the pCODR Economic Guidance Panel’s best estimates of the cost-effectiveness of eribulin. pERC reviewed there-analyses conducted by the Economic Guidance Panel and their rationale for using the 18 month estimates. pERC agreed with the Economic Guidance Panel that the analyses based on clinical data from the 18 month pre-planned analysis are more robust than those based on clinical data from the 24 month unplanned analysis. pERC considered that results observed at 24 months may be biased as a result of multiple unplanned looks at the data and that these more favourable estimates may not be stable over time.

Provincial Funding Report: pCODR Provincial Funding Summary Report  pCODR Provincial Funding Summary report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-provfund_halaven-mbc.pdf
Final Recommendation Report: pCODR-pERC Final Recommendation report  pCODR-pERC Final Recommendation report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-halavenmb-fn-rec.pdf
Final Clinical Guidance Report: pCODR Final Clinical Guidance Report  pCODR Final Clinical Guidance report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-halavenmb-fn-cgr.pdf
Final Economic Guidance Report: pCODR Final Economic Guidance report  pCODR Final Economic Guidance report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-halavenmb-fn-egr.pdf

†The information referenced on this page is compiled from publicly available documents published by pCODR and is available through the embedded links.


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