Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) issued its final appraisal decision (FAD) recommending reimbursement of Lenvima® (lenvatinib) for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine (RAI-R DTC). This decision is part of a Multiple Technology Assessment resulting in the recommendation of both lenvatinib and sorafenib.
The European Medicines Agency (EMA) approval and subsequent NICE recommendation was based on the pivotal Phase Three SELECT study that showed lenvatinib was associated with significant improvements in progression-free survival (PFS) in patients with progressive RAI-R DTC. Median PFS with lenvatinib was 18.3 months compared to 3.6 months on placebo (HR 0.21; 99% CI 0.14–0.31, p<0.001). In addition, the objective response rate was 64.8% versus 1.5% with placebo (p<0.001).
This positive NICE recommendation comes after the EMA approved lenvatinib for use almost three years ago in May 2015, and the Scottish Medicines Consortium (SMC) approved it for reimbursement in October 2016. This was followed by the All Wales Medicines Strategy Group’s approval in October 2017.
“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. While patients in Scotland and Wales had access to lenvatinib much sooner – 2016 and 2017 respectively – it’s a real shame that due to a poor process that patients in England have had to wait much longer,” commented Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai.