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NICE reverses its rejection of Eisai’s Lenvima

The cost-effectiveness watchdog has now backed the thyroid cancer treatment


The National Institute for Health and Care Excellence (NICE) has recommended the use of Lenvima (lenvatinib) after manufacturer Eisai was able to supply new data on its use.

A final appraisal determination from the cost-effectiveness watchdog for England and Wales backs Lenvima as a treatment for locally advanced or metastatic, differentiated thyroid cancer, refractory to radioactive iodine (RAI-R DTC).

This particular subset of patients in Scotland and Wales can already access Eisai’s medicine due to approvals from the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy.

However, NICE - the body that weighs up medication costs versus disease effectiveness for NHS England - originally rejected Lenvima last year, claiming in draft guidance the drug was not cost-effective.

Backtracking on this decision, NICE has now recommended the drug following the results of the phase III SELECT STUDY, which showed that patients on Lenvima had a median PFS of 18.3 months compared to 3.6 months for those on placebo.

The positive recommendation comes three years after the tyrosine kinase inhibitor achieved an initial EU licence from the European Medicines Agency (EMA).

Commenting on the recent recommendation, Gary Hendler, chairman and chief executive officer EMEA for Eisai, said: “After almost three years of being licensed in the EU, I am really very pleased that NICE is finally recommending the use of lenvatinib so that patients with this form of thyroid cancer will at last have access to it in England.

“It’s a real shame that due to a poor process that patients in England have had to wait much longer [than their Welsh and Scottish counterparts].”

Despite the typical ‘good’ prognosis that is associated with thyroid cancer, the aggressive form of the disease, in which patients are refractory to radioactive iodine therapy, carries a much poorer prognosis with 66% of patients dying within five years of diagnosis.

Lenvima, a once-daily oral, works by inhibiting the activities of numerous receptor proteins implicated in tumour growth and spread.

Kate Farnell, chief executive officer of the Butterfly Thyroid Cancer Trust, said: “RAI-R DTC can impact severely on a patient’s life [and] with limited options available for patients with this type of thyroid cancer, we very much welcome this decision from NICE that demonstrates that these patients are no longer forgotten.”

Article by
Gemma Jones

22nd February 2018

From: Regulatory



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