Today the National Institute for Health and Clinical Excellence (NICE) announced that it will continue not to recommend Halaven® (eribulin) for the treatment of locally advanced or metastatic breast cancer in England and Wales, despite this innovative therapy demonstrating proven benefits of improving overall survival rates, with an expected and manageable safety profile.
Following an appeal by Eisai, NICE has observed that ‘the discussion and decision of the Appraisal Committee on toxicity were not reported appropriately in the Final Appraisal Document (FAD)’ in relation to eribulin. The corresponding sections of the FAD are being re-drafted in light of the error. Despite the need for new treatment options, their overall recommendation denying eribulin use in England and Wales remains. Eribulin is the first, single-agent chemotherapy to show a statistically significant overall survival benefit in women with heavily pre-treated advanced breast cancer (compared to treatment of physician choice). Importantly, eribulin has an expected and manageable safety profile which is in line with other single-agent chemotherapy treatments for advanced breast cancer in this setting.2
Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, Leeds, commented, “I am delighted that NICE has recognised the errors made regarding eribulin in the original report and made these corrections. However, the fact remains that NICE’s decision denies women with advanced breast cancer access to the only chemotherapy that we know can prolong the time they could spend with their loved ones. The EMBRACE trial demonstrated that eribulin provides improved overall survival compared to the single agent treatments that oncologists are currently able to use. Importantly, the survival benefit from eribulin is not outweighed by any unexpected or unmanageable side effects, which is important for these women. NICE has ignored the innovative nature of eribulin and failed to recognise the value for women with advanced breast cancer in England and Wales.”
Despite NICE’s ruling, patients in England can access eribulin the via the Government’s Cancer Drugs Fund (CDF). To date many women in England have been treated with eribulin via this route and it is within the top twelve most prescribed drugs through this system. However, the CDF does not extend to patients nationally and Northern Ireland so unequal access will continue to be a problem.
“Eisai is dismayed that NICE has chosen not to rethink its denial of eribulin for women with locally advanced or metastatic breast cancer in England and Wales. At this point NICE is not giving enough support to women with advanced breast cancer and the physicians who want to treat them. We hope that NICE grant a rapid re-review as new data is constantly emerging that will help inform their decision,” said Nick Burgin, European Director of Market Access, Eisai.
Today’s published FAD on eribulin use comes after an appeal by Eisai on NICE’s earlier ruling (November 2011) to not recommend eribulin.
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