regulatoryEisai has criticized strongly NHS England (NHSE) for further delaying access to a number of new cancer treatments. This failure is a result of the implementation by NHSE of a new Cancer Drugs Fund (CDF), following a consultation NHSE confirmed at their Board meeting recently. Those new licensed drugs that have been denied access since May 2015 will have to wait until at least July 2016 before they can be considered for the fund, though details around this process are vague.

Lenvima (lenvatinib) is one such drug that has been stuck in limbo as a result of the consultation. Lenvatinib is used to treat an advanced form of thyroid cancer and may delay the progression of the cancer to a median of 18.3 months, compared with 3.6 months with a placebo. Eisai confirms that patients in England may have to wait for an unspecified period in order to access lenvatinib.

“This is devastating news for patients with advanced thyroid cancer. These patients may belong to a small group, only 200 patients per year, but their need is great. Lenvatinib can make a real difference to the lives of patients owing to its significant progression-free survival benefit and so this news is particularly hard to understand,” comments Dr Jonathan Wadsley, Consultant Clinical Oncologist, University of Sheffield.

“This is hugely disappointing news for people living with thyroid cancer that has proved resistant to usual therapies. There are very few treatment options left for those patients whose thyroid cancer is not responsive to radio-iodine. The fact that an approved treatment exists which could delay progress of their cancer but they are not able to access it is particularly heartbreaking,” comments Kate Farnell MBE, Founder of the Butterfly Thyroid Cancer Trust.

“The decision to implement the new CDF pretty much as it was proposed in the consultation will put cancer treatment back to where England was prior to the creation of the Fund which is a tragedy for patients. Time is not a luxury that these patients have. I implore NHS England to rethink the decision around access to drugs that have been licensed since May 2015 to ensure important treatments like lenvatinib are made available to people as soon as possible. This is a drug that is manufactured in Hertfordshire, exported across the world, and yet people in England are denied access to it. This is an utterly disgraceful situation,” commented Gary Hendler, CEO Eisai EMEA and President, Global Oncology Business Unit.

Lenvatinib is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

[i] Lenvatinib was granted orphan drug designation for locally advanced follicular and papillary thyroid cancer. The treatment was given Marketing Authorization approval from the European Commission in May 2015, and has been denied access to the CDF process ever since.

Lenvatinib demonstrates significantly prolonged progression-free survival (PFS) in RAI refractory DTC versus placebo. Lenvatinib shows a median 18.3 months progression-free survival PFS versus 3.6 months for a placebo (hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, p<0.0001). For lenvatinib, the most common treatment related adverse events were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight and nausea.