Following the release of the Final Appraisal Determination (FAD) in February 2018 and receipt of an appeal lodged by Eisai, NICE has realised that a procedural error was made in the handling of the above technology appraisal. The appeal lodged by Eisai related to the inclusion of section 3.6 in the FAD and the subsequent interpretation of the committee’s recommendation. Although section 1.1 of the FAD recommended both drugs within their marketing authorisations, the committee did intend the recommendation for both drugs to be limited to first line use only (that is, no prior tyrosine kinase inhibitor (TKI); therefore an optimised recommendation for lenvatinib.

Given that section 3.6 was introduced at the FAD stage and had a material impact on committee’s recommendation, NICE acknowledges that a second ACD should have been issued to allow stakeholders the opportunity to comment on the committee’s conclusion on sequential treatment. As a consequence, we are now releasing this Appraisal Consultation Document (ACD) for consultation. The responses to the consultation will be discussed at a technology appraisal committee meeting on 15 May 2018.

This page was last updated: