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Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease

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1 Recommendations

1.1 Nivolumab is not recommended, within its marketing authorisation, for the adjuvant treatment of melanoma with lymph node involvement or metastatic disease that has been completely resected in adults.

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the Cancer Drugs Fund before final guidance was published. For those people, nivolumab will be funded by the company until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This appraisal reviews the evidence collected in the Cancer Drugs Fund for nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease (NICE technology appraisal guidance 558).

During the original appraisal, standard care was routine surveillance. Now, dabrafenib with trametinib is an option and pembrolizumab is available through the Cancer Drugs Fund. These treatments are suitable for some people with this disease.

Clinical evidence shows that nivolumab improves survival without the cancer coming back (recurrence-free survival) compared with ipilimumab. There are currently no trials comparing nivolumab with standard care in the NHS. An indirect comparison suggests that nivolumab is likely to improve recurrence-free survival compared with routine surveillance. The data from the Cancer Drugs Fund and the trial are still quite new so it is uncertain if nivolumab increases the length of time people live, or by how much (overall survival).

Because of this uncertainty the cost-effectiveness estimates vary. The most likely estimates are above what NICE considers a cost-effective use of NHS resources. Therefore, nivolumab is not recommended for routine use. Nivolumab will no longer be available in the Cancer Drugs Fund for this indication after final guidance is published, but people already taking it will be able to continue.