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NICE Recommends Nivolumab for Adjuvant Treatment of Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease

More evidence on nivolumab is being collected
23 Jan 2019
Melanoma and other skin tumours;  Cancer Immunology and Immunotherapy

On 23 January 2019, NICE issued Technology appraisal guidance [TA558] with evidence-based recommendations on nivolumab (Opdivo) for use within the Cancer Drugs Fund 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 conditions in the managed access agreement are followed.

More evidence on nivolumab is being collected, until enough data have been collected. After this, NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. Patients 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.

There are currently no adjuvant immunotherapies recommended by NICE for routine use in patients who have melanoma with lymph node involvement or metastatic disease, who have had complete resection.

Clinical evidence from CheckMate 238, an ongoing randomised trial, shows that nivolumab improves recurrence-free survival compared with ipilimumab. There are currently no trials comparing nivolumab with routine surveillance, which is the standard of care in the NHS. An indirect treatment comparison using ipilimumab as a common comparator showed that nivolumab is likely to improve recurrence-free survival compared with routine surveillance. However, there is currently no reliable clinical evidence to show that it improves overall survival. This means that the clinical and cost effectiveness of adjuvant nivolumab is uncertain.

Nivolumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainties. Longer follow‑up data from CheckMate 238 on overall and progression-free survival would help to address these uncertainties. Therefore, adjuvant nivolumab is recommended for use in the Cancer Drugs Fund for patients who have melanoma with lymph node involvement or metastatic disease.

Proposals for further data collection in the Cancer Drugs Fund include:

  • recurrence-free survival
  • overall survival
  • long-term follow‑up of patients who had nivolumab as an adjuvant treatment who develop advanced disease and have nivolumab again to treat metastatic disease.
Last update: 23 Jan 2019

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