Nivolumab–relatlimab is recommended as an option for untreated advanced (unresectable or metastatic) melanoma in people 12 years and over, only if:
nivolumab–relatlimab is stopped after 2 years of treatment, or earlier if the cancer progresses, and
the company provides it according to the commercial arrangement.
This recommendation is not intended to affect treatment with nivolumab–relatlimab that was started in the NHS before this guidance was published. Anyone 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. For children or young people, this decision should be made jointly by the clinician, the child or young person, and their parents or carers.
Why the committee made these recommendations
People who have advanced melanoma usually have nivolumab plus ipilimumab. When this is not suitable, people can have nivolumab or pembrolizumab. In clinical practice, most people stop having these treatments after 2 years, and this is the assumption the company has made in its economic model. So nivolumab–relatlimab will also be stopped after 2 years.
Clinical trial evidence shows that people who have nivolumab–relatlimab have longer before their cancer gets worse than people having nivolumab. There is no direct evidence comparing nivolumab–relatlimab with pembrolizumab or with nivolumab plus ipilimumab. But, indirect comparisons suggest that people who have nivolumab–relatlimab also have longer before their cancer gets worse than people having pembrolizumab. Compared with nivolumab plus ipilimumab, the evidence suggests that nivolumab–relatlimab is as effective.
The indirect evidence also suggests that people who have nivolumab–relatlimab live longer than people who have the other treatments. But there's not enough data yet to be certain about this.
Because of the uncertainty in the clinical-effectiveness evidence, the cost-effectiveness estimates need to be towards the lower end of the range that NICE considers an acceptable use of NHS resources. The estimates for the comparison with pembrolizumab and with nivolumab plus ipilimumab, which are the treatments most commonly used in the NHS, are at or below this lower end. So nivolumab–relatlimab is recommended.