1.1 Nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy is not recommended, within its marketing authorisation, for untreated metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
1.2 This recommendation is not intended to affect treatment with nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy 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
Standard care for untreated metastatic NSCLC that has no EGFR or ALK mutations is usually immunotherapy plus platinum-doublet chemotherapy. People have different treatments depending on their PD‑L1 tumour proportion score and whether they have squamous or non-squamous NSCLC.
Clinical trial evidence suggests that people who have nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy (nivolumab combination) live longer than those who have platinum-doublet chemotherapy alone. Nivolumab combination has only been compared indirectly with other treatments. The results of these indirect comparisons of nivolumab combination with atezolizumab plus bevacizumab, carboplatin and paclitaxel (atezolizumab combination), pembrolizumab monotherapy, and pembrolizumab plus pemetrexed and platinum chemotherapy are uncertain. It is also uncertain how long the effect of nivolumab combination lasts.
The cost-effectiveness estimates for nivolumab combination compared with platinum-doublet chemotherapy, atezolizumab combination and pembrolizumab monotherapy are higher than what NICE considers an acceptable use of NHS resources. The cost-effectiveness estimates compared with pembrolizumab plus pemetrexed and platinum chemotherapy are uncertain because of problems with the analysis.
There is no additional data that could be collected through the Cancer Drugs Fund or from clinical trials that could resolve the uncertainty. So, nivolumab combination is not recommended for routine use or through the Cancer Drugs Fund.