NICE has approved nivolumab (Opdivo) for use within the Cancer Drugs Fund (CDF) as adjuvant treatment for completely resected melanoma with lymph node involvement or metastatic disease.
In September, NICE ruled against the routine use of nivolumab for this indication, citing uncertainty about the clinical effectiveness and therefore the cost-effectiveness of the treatment.
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.
NICE has acknowledged that nivolumab has the potential to be cost-effective, but said more evidence is needed to address the clinical uncertainties. Longer follow-up data from CheckMate 238 may address this uncertainty.
In the meantime, adjuvant nivolumab is recommended for use in the Cancer Drugs Fund for patients with melanoma and lymph node involvement or metastatic disease. According to company estimates, around 1480 people will be eligible for this treatment.
The decision is open for appeal until 14 December 2018.