1 Recommendations

1.1 Lenvatinib plus everolimus is recommended as an option for treating advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, only if:

  • their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 and

  • the company provides lenvatinib according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with lenvatinib plus everolimus that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

1.3 In the NHS, advanced renal cell carcinoma that has progressed after 1 tyrosine kinase inhibitor is treated with axitinib, nivolumab or cabozantinib. The evidence from a single clinical trial suggests that, on average, people live around 10.1 months longer if they have lenvatinib plus everolimus rather than everolimus alone. In the trial, lenvatinib plus everolimus caused side effects, leading many patients to interrupt or even stop treatment. This is despite the patients enrolled in the trial being relatively fit (that is, they had an ECOG performance status score of 0 or 1).

1.4 The cost-effectiveness analyses for lenvatinib plus everolimus show it's more effective and less costly than cabozantinib and nivolumab. Compared with axitinib, the cost-effectiveness estimates are within what NICE normally considers acceptable. So, NICE is recommending lenvatinib plus everolimus as an option for use in the NHS in people with an ECOG performance status score of 0 or 1.

  • National Institute for Health and Care Excellence (NICE)