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Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer [ID1566]

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1 Recommendations

1.1 Nivolumab plus ipilimumab and 2 cycles of platinum-based 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-based 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 can have different treatments depending on their PD-L1 tumour proportion score (TPS) and whether they have squamous or non-squamous NSCLC. These include:

  • platinum-doublet chemotherapy for NSCLC with a PD-L1 TPS below 50%, with or without pemetrexed maintenance for non-squamous NSCLC

  • atezolizumab plus bevacizumab, carboplatin and paclitaxel (atezolizumab combination) for non-squamous NSCLC with a PD-L1 TPS below 50%

  • pembrolizumab monotherapy for NSCLC with a PD-L1 TPS of at least 50%

  • pembrolizumab plus pemetrexed and platinum chemotherapy for non-squamous NSCLC.

Some people have pembrolizumab plus carboplatin and paclitaxel for squamous NSCLC through the Cancer Drugs Fund, but this is not considered to be standard care.

Clinical trial evidence suggests that people who have nivolumab plus ipilimumab and 2 cycles of platinum-based chemotherapy (nivolumab combination) live longer than those who have platinum-doublet chemotherapy. There are no trials directly comparing nivolumab combination with other treatments. The results of indirect comparisons of nivolumab combination with atezolizumab combination and pembrolizumab monotherapy are confidential. But they are useful for supporting decisions despite some uncertainty. Nivolumab combination has not been compared with pembrolizumab plus pemetrexed and platinum chemotherapy, which is widely used in the NHS.

In the economic model it is uncertain how long the effect of nivolumab combination lasts. It is also unclear whether people having it live longer depending on their PD‑L1 TPS and the type of NSCLC they have.

Nivolumab combination is only likely to meet NICE's end of life criteria for squamous NSCLC with a PD-L1 TPS below 50%. The cost-effectiveness estimates for nivolumab combination compared with platinum-doublet chemotherapy, atezolizumab combination and pembrolizumab monotherapy are higher than what NICE considers acceptable. This is even when the end of life criteria are applied for squamous NSCLC with a PD-L1 TPS below 50%.

It is unlikely that collecting more data in the Cancer Drugs Fund would resolve the uncertainty in the modelling. So, nivolumab combination cannot be recommended for routine use or through the Cancer Drugs Fund.