1 Recommendations

1.1

Fruquintinib can be used as an option at third line or later to treat metastatic colorectal cancer in adults when previous treatment has included:

fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without anti-vascular endothelial growth factor (VEGF) treatment, and
anti-epidermal growth factor receptor (EGFR) treatment if the cancer is RAS wild-type, unless this was not suitable.

Fruquintinib can only be used if:
trifluridine–tipiracil with bevacizumab is not suitable
the company provides it according to the commercial arrangement.

1.2

This recommendation is not intended to affect treatment with fruquintinib 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 healthcare professional consider it appropriate to stop.

What this means in practice

Fruquintinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Fruquintinib must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that fruquintinib provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support implementation of this guidance.

Why the committee made these recommendations

Standard third-line treatment for metastatic colorectal cancer after chemotherapy (with or without anti-VEGF treatment) and anti-EGFR treatment is trifluridine–tipiracil with bevacizumab. When this is not suitable, treatment is trifluridine–tipiracil alone or regorafenib. Because most people will have had trifluridine–tipiracil at third line (either with bevacizumab or alone), regorafenib is more commonly used at fourth line.

Fruquintinib is not expected to replace trifluridine–tipiracil with bevacizumab. So for this evaluation, fruquintinib was considered only when trifluridine–tipiracil with bevacizumab is not suitable. This is narrower than the marketing authorisation.

Clinical trial evidence shows that fruquintinib increases how long people have before their cancer gets worse and how long they live, compared with placebo. Fruquintinib has not been directly compared in a clinical trial with regorafenib or trifluridine–tipiracil alone, but an indirect comparison suggests that it is likely to increase how long people have before their cancer gets worse.

There are some uncertainties in the economic model. But considering the condition's severity, and its effect on quality and length of life, the cost-effectiveness estimates are within the range NICE normally considers an acceptable use of NHS resources. So, fruquintinib can be used.