1.1 Nivolumab is recommended 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.
1.2 This recommendation is not intended to affect treatment with nivolumab 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
There are currently no adjuvant immunotherapies recommended by NICE for routine use in people 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 how long people live and how long people live without their disease coming back would help to address these uncertainties. Therefore, adjuvant nivolumab is recommended for use in the Cancer Drugs Fund for people who have melanoma with lymph node involvement or metastatic disease.