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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1

Nivolumab plus ipilimumab should not be used for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults.

1.2

This recommendation is not intended to affect treatment with nivolumab plus ipilimumab 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.

What this means in practice

Nivolumab with ipilimumab is not required to be funded in the NHS in England for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that nivolumab with ipilimumab offers value for money.

Why the committee made these recommendations

Usual treatment for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in adults is pembrolizumab or chemotherapy.

Clinical trial evidence shows that nivolumab with ipilimumab increases how long people have before their cancer gets worse compared with chemotherapy. It has not been directly compared in a clinical trial with pembrolizumab, but indirect comparisons suggest that it increases how long people have before their cancer gets worse compared with pembrolizumab. There is no evidence available to show whether nivolumab with ipilimumab increases how long people live compared with chemotherapy or pembrolizumab.

There are uncertainties in the economic model. This is because of the assumptions used and the way the modelling was done. Also, the cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, nivolumab with ipilimumab should not be used for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.

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