cancer oncologyEisai is dismayed and concerned that patients will be forced to wait almost 3 years to access a proven treatment for advanced thyroid cancer, owing to a “black hole” in the inequitable CDF process. Lenvatinib is not in the relaunched Cancer Drugs Fund (CDF) and NICE guidance will not be published until at least 2018.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).

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 that 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 that 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 because of 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.