Eisai Calls for Immediate Solution to Rare Cancers Black Hole

HATFIELD, England, July 8, 2016 /PRNewswire/ --

FOR UK MEDIA ONLY 

Transitional arrangement essential for people with RAI-R differentiated thyroid cancer who face years waiting for access to Lenvima® (lenvatinib)  

Eisai is dismayed and concerned that patients will be forced to wait almost three years to access a proven treatment for advanced thyroid cancer, due to a 'black hole' in the inequitable CDF process. Lenvatinib is not in the re-launched Cancer Drugs Fund (CDF) and NICE guidance will not be published until at least 2018.

Lenvatinib is indicated for the treatment of adults with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (R-RAI).^[1]

Eisai is calling for a transitional arrangement to allow access for lenvatinib in advanced thyroid cancer, which is caught in limbo because it was not appraised before the CDF closed. At that time, lenvatinib did not qualify for NICE review, because it would have a low budget impact for the NHS. The company will consider all options, including possible legal action, to secure fair and equitable access for people with rarer cancers.

"It is sad that patients living in England cannot access lenvatinib for advanced thyroid cancer which was developed and manufactured in this country. We believe there is an immediate solution, a transitional arrangement, to allow patients access to a treatment which has been disproportionately delayed by the changes in the CDF process. Eisai may be forced to consider its level of investment in the UK because it is unacceptable that drugs which are manufactured in England cannot be provided to people in England, without delays of many years," states Gary Hendler, Chairman and CEO Eisai EMEA.

"It is unacceptable that people who have exhausted other treatment options for RAI-R differentiated thyroid cancer are denied access to lenvatinib. People with advanced thyroid cancer do not have time to wait. This treatment is approved for use in Europe and the health system in England must provide access to lenvatinib as soon as possible," states Kate Farnell MBE, Founder, Butterfly Thyroid Cancer Trust.

"As a clinician I am appalled by this latest delay in access to the treatment (lenvatinib). I treat people with advanced thyroid cancer, refractory to radio-iodine treatment who are eligible for lenvatinib, but remain unable to receive the treatment due to red tape. I call on NHS England to allow clinicians like me to prescribe this treatment to my patients today," states Georgina Gerrard, Consultant Clinical Oncologist, The Leeds Teaching Hospitals.

Lenvatinib was approved by the European Commission more than a year ago, in May 2015, and is manufactured in Hatfield, Hertfordshire, at Eisai's highly specialised facility. Lenvatinib demonstrates an 18.3 months progression free survival versus 3.6 months for placebo p<0.0001) in RAI-R differentiated thyroid cancer. Adverse events were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.^[2]

Notes to Editors  

About Thyroid Cancer 

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.^[3] The incidence of thyroid cancer has increased significantly in the last decade by 69% and 65% in men and women, respectively.^[7] The most common types of thyroid cancer, papillary and follicular (including Hürthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases.^[4] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).^[5]

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References  

1. Summary of Product Characteristics Lenvima. 2015.

2. Schlumberger M et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM 2015; 372: 621-630. Available at http://www.nejm.org/doi/full/10.1056/NEJMoa1406470  Accessed: July 2016

3. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 [http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages]. Accessed: July 2016

4. Cabanillas ME., Dadu R. Optimizing therapy for radioactive iodine-refractory differentiated thyroid cancer: Current state of the art and future directions. Minerva Endocrinol 2012 Dec; 37(4): 335-356.

5. Thyroid Cancer Basics. 2011. Available at: http://www.thyca.org . Accessed: July 2016