Rare cancer drug which significantly delays progression of advanced thyroid cancer is left off relaunched Cancer Drugs Fund

People with radioiodine refractory differentiated thyroid cancer are overlooked as Lenvima is not scheduled for evaluation by NICE or the new Cancer Drugs Fund.

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 (RAI-R) and was granted an accelerated assessment and approved by the European Commission in May 2015. It is available in many countries in Europe already, including Germany where it has been available from May 2015.

Lenvatinib is not listed on the relaunched CDF and NICE has indicated it will not be able to issue final guidance on the treatment until around June 2018. Lenvatinib has been in limbo ever since 2015, when it was refused entry to the CDF as it was closed to new medicines and was not scheduled for assessment by NICE due to its low budget impact. To compound this situation, Eisai is aware of at least 20 individual funding requests made by clinicians in England for the use of lenvatinib in eligible patients, and no patient has yet received the treatment.

Eisai calls for a flexible solution in the form of urgent transitional arrangements that would ensure patients can access lenvatinib through the CDF. Eisai has met with NHS England and NICE but despite extensive dialogue, to date no agreement has been made.

"As a clinician I am now in the difficult position of having to explain to my patients why I cannot prescribe a drug that is available in other European countries. This is obviously very disappointing given the significant progression free survival benefit demonstrated by lenvatinib for patients with radioiodine refractory DTC and my colleagues and I will not be able to do so in the immediate foreseeable future," comments Dr Nick Reed, Consultant Clinical Oncologist, Beatson Oncology Centre, Glasgow, UK.

"On behalf of patients with advanced thyroid cancer, we have no option but to fight this inequitable situation. For once this is not about cost as we have not been asked to be evaluated for clinical or cost effectiveness but we would welcome the opportunity to do so but also the new CDF is underwritten by the pharmaceutical industry where we take 100% of the financial risk associated with the Fund. This situation would indicate that England is turning the clock back and fast becoming the sick child of Europe in terms of access to innovative cancer drugs. Eisai will therefore fight aggressively for the rights of patients, which may include taking legal action.

"Lenvatinib was developed in the UK and is now manufactured in Hertfordshire in our state of the art facility. With no access to lenvatinib for people with advanced thyroid cancer in the UK for possibly 3 years, we may be forced to reconsider our future investments here. The NHS is one of the best healthcare systems in the world and so there simply must be a solution for patients," comments Gary Hendler, Chairman and CEO Eisai EMEA.