1 Recommendations

1.1 Nivolumab is recommended, within its marketing authorisation, as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease. It is recommended only if the company provides nivolumab according to the commercial arrangement.

Why the committee made these recommendations

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

Until recently, standard care for people with completely resected melanoma was routine surveillance. Adjuvant immunotherapies such as dabrafenib with trametinib or pembrolizumab alone are now available for some people.

Clinical evidence shows that adjuvant nivolumab increases how long people live without the cancer coming back compared with adjuvant ipilimumab (an immunotherapy that is not used in the NHS). There are no trials directly comparing nivolumab with standard care in the NHS. But an indirect comparison suggests that people taking nivolumab are likely to live longer before the cancer comes back than with routine surveillance. There are still not enough data from the Cancer Drugs Fund and the trial to be certain by how much nivolumab increases the length of time people live.

Because of the uncertainty the cost-effectiveness estimates vary. However, the most likely estimates are within what NICE considers a cost-effective use of NHS resources. Therefore, nivolumab is recommended.

  • National Institute for Health and Care Excellence (NICE)