NICE Fails to Grant Access to Innovative Treatment for Women With Advanced Breast Cancer, Despite Evidence That it Could Extend Their Lives
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.[1]
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).[2] 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.
Notes to Editors
Halaven is the EU trade name for eribulin. Eribulin is approved in Europe for the treatment of patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.[3]
Eribulin was launched on 20 April 2011 in the UK and is commercially available in the UK. It is funded via the Cancer Drug Fund in England and through private insurance companies. The therapy is approved in the European Union, USA, Switzerland, Japan, and Singapore. Eribulin is currently commercially available in Austria, Denmark, Finland, Germany, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Singapore, Switzerland, United Kingdom and the USA.
Halaven® (eribulin)
Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.[2] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Global Phase III Clinical Study (EMBRACE)
EMBRACE was an open-label, randomised, global, multi-centre, parallel two-arm study designed to compare overall survival in patients treated with eribulin versus a Treatment of Physician's Choice (TPC) arm. TPC was defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. The study included 762 patients with metastatic breast cancer who previously had been treated with at least two and a maximum of five prior chemotherapies, including an anthracycline and a taxane. The vast majority (96%) of patients in the TPC arm received chemotherapy.[3]
In the total Phase III EMBRACE study population, eribulin was shown to prolong overall survival in heavily pre-treated patients with metastatic breast cancer compared to patients receiving TPC by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.067, 0.96) nominal p=0.014).[2] A pre-planned analysis of patients from Region 1 of the study (North America/Western Europe/Australia) showed a significant overall survival benefit of eribulin over TPC of 3.0 months (nominal p=0.031).[2]
Eisai also submitted data on the post capecitabine population which includes 554 patients (74% of the trial population) that showed a 2.9 months improvement in survival (p=0.018) vs TPC.
The most commonly reported adverse reactions among patients treated with eribulin in the EMBRACE study were fatigue (asthenia), a decrease in infection-fighting white blood cells (neutropenia), hair loss (alopecia), numbness and tingling in arms and legs (peripheral neuropathy), nausea and constipation. Peripheral neuropathy was the most common adverse event leading to discontinuation from eribulin, occurring in less than 5% of the patients involved in the EMBRACE trial. Neutropenia only led to eribulin discontinuation for 0.6% patients. Death due to serious side effects, discontinuation and dose interruptions to treatment were lower in the eribulin arm of the trial compared with the TPC arm.[3]
Metastatic Breast Cancer
Breast cancer is now the most common cancer in the UK and the lifetime risk of being diagnosed with breast cancer is one in eight for women in the UK.[4] In 2008, almost 47,700 women were diagnosed with breast cancer, around 130 women a day.[5]
Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. Approximately five percent of women with breast cancer will have metastatic disease at the time of diagnosis[5] and 35% will develop metastatic disease at some point after the initial diagnosis.[6] Only 13% of women presenting with metastatic breast cancer will survive beyond five years.[6]
To view a personal account from a woman living with metastatic breast cancer please visit:
http://www.streamingwell.com/melanies-story-surviving-advanced-breast-cancer-video.html
Eisai in Oncology
Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
About Eisai
Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.
Eisai concentrates its R&D activities in three key areas:
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and Belgium.
For further information please visit our web site http://www.eisai.com
References
1. National Institute for Health and Clinical Excellence.Final appraisal determination.Eribulin for the treatment of locally advanced or metastatic breast cancer. March 2012
2. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914 -923
3. Summary of Product Characteristics Halaven (updated March 2011). Available at: http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/
4. Cancer Research UK. Cancer Statistics - Key Facts. Available at: http://info.cancerresearchuk.org/cancerstats/types/breast/ (Accessed 1 April 2011)
5. Cancer Research UK. Statistics and outlook for breast cancer. Available at: http://www.cancerhelp.org.uk/type/breast-cancer/treatment/statistics-and-outlook-for-breast-cancer (Accessed 1 April 2011)
6. Synovate track the usage of anti-cancer drugs, through a representative panel of cancer specialists completing forms directly from patient medical records in each country, including the UK. Eisai data on file.
