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NICE guidance on nivolumab for advanced melanoma

Nivolumab will not be routinely available in the NHS for the adjuvant treatment of advanced melanoma, suggests new draft guidance from NICE.

Nivolumab was approved for use within the Cancer Drugs Fund (CDF) in 2019. The decision was based on evidence from the CheckMate 238 trial of adjuvant nivolumab vs adjuvant ipilimumab in adults with completely resected stage 3B, 3C, or 4 melanoma. At that point, participants had been followed up for a median of 24 months.

Since the original appraisal, patients in CheckMate 238 have now been followed for a minimum of 48 months. A statistically significant improvement in recurrence-free survival (RFS) has been observed with nivolumab compared with ipilimumab. However, overall survival data are still immature.

NICE also reviewed the evidence collected in the CDF for nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease (NICE technology appraisal guidance 558).

Furthermore, there are no head-to-head studies of nivolumab vs standard care in the NHS. An indirect comparison conducted by the pharmaceutical company suggests nivolumab is likely to improve RFS compared with routine surveillance.

While a NICE appraisal committee agreed that nivolumab improves RFS compared with ipilimumab, it said the data from the CDF and the trial are still quite immature and there is uncertainty about long-term benefit and cost-effectiveness.

Hence, the committee have concluded that nivolumab should not be recommended for routine use. Nivolumab will no longer be available in the CDF for this indication after final guidance is published, although people already taking it will be able to continue.

The draft decision is open for public comment until November 25, 2020. Comments can be submitted here.


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