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Evaluation of Eisai’s advanced thyroid cancer treatment blocked until 2018 in England

Published on 02/08/16 at 09:38am

Following negotiations between the NHS, NICE and Japanese pharmaceutical company Eisai, differentiated thyroid cancer (RAI-R DTC) drug lenvima (levatinib) has been left off the relaunched Cancer Drugs Fund’s (CDF) evaluation list, meaning that sufferers of the disease in England will have to wait up to two to three years before having access to the treatment. NICE has stated that it will not be able to issue final guidance on the treatment until June 2018.

Levatinib was granted an accelerated assessment and approved by the European Commission in May 2015 and is available in many European countries already.

In its trials, Lenvatinib has been shown to significantly slow the progression of RAI-R DTC, providing a median progression free survival benefit of 18.3 months versus 3.6 months for placebo. Additionally, almost two-thirds of patients responded with a significant objective response rate (ORR) of 64.8% versus 1.5% for placebo.

Dr Nick Reed, consultant clinical oncologist at Beatson Oncology Centre in Glasgow commented: “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.”

Eisai has also voiced its disappointment at the decision; chairman and CEO of Eisai EMEA Gary Hendler remarked: “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."

These comments come after previous criticism of reforms to the CDF, arguing that their approval would deny access to key drugs and set back cancer treatment in England to levels prior to the Fund’s implementation in 2011. The company has also warned it may be forced to re-evaluate its level of future investments in the UK as a result of the organisation’s latest decision:

“Lenvatinib was developed in the UK and is now manufactured in Hertfordshire in our state of the art facility,” Hendler continued. “With no access to lenvatinib for people with advanced thyroid cancer in the UK for possibly three 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.”

This is not the first time Eisai has threatened to pull its investment, after voicing criticism of NICE’s assessment criteria in November 2013.

Matt Fellows

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