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1 Recommendations

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1 Recommendations

1.1 Lenvatinib with pembrolizumab is recommended as an option for untreated advanced renal cell carcinoma in adults, only if:

  • their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and

  • nivolumab with ipilimumab would otherwise be offered and

  • the companies provide lenvatinib and pembrolizumab according to the commercial arrangements (see section 2).

1.2 This recommendation is not intended to affect treatment with lenvatinib with pembrolizumab 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

Current treatment for untreated advanced renal cell carcinoma includes pazopanib, tivozanib or sunitinib. Cabozantinib, and nivolumab plus ipilimumab, are also recommended for intermediate or poor-risk cancer as defined by the International Metastatic Renal Cell Carcinoma Database Consortium.

Clinical trial evidence suggests that people having lenvatinib plus pembrolizumab have longer before their disease gets worse than people having sunitinib, but this is uncertain for people with favourable-risk cancer. Pazopanib and tivozanib are thought to have similar clinical effectiveness to sunitinib, so lenvatinib plus pembrolizumab is also likely to be more effective than them. Results of indirect comparisons are uncertain, but show that lenvatinib plus pembrolizumab may increase the time people have before their disease gets worse compared with cabozantinib, and nivolumab plus ipilimumab.

In favourable-risk cancer, all the cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. In intermediate and poor-risk cancer, the cost-effectiveness estimates are only within the range that NICE considers an acceptable use of NHS resources when nivolumab plus ipilimumab would otherwise be offered. So, lenvatinib plus pembrolizumab is recommended for this group.