1.1 Trifluridine–tipiracil is not recommended, within its marketing authorisation, for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more systemic treatment regimens.
1.2 This recommendation is not intended to affect treatment with trifluridine–tipiracil 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.
Why the committee made these recommendations
Current treatment for metastatic gastric cancer and gastro-oesophageal junction cancer, for most people who have had 2 treatments, is best supportive care.
The clinical evidence suggests that people having trifluridine–tipiracil live longer compared with best supportive care. But the evidence also suggests that it is unlikely to extend how long people live by at least 3 months, particularly in the people who are most relevant to the NHS. This means trifluridine–tipiracil does not meet NICE's criterion to be considered a life-extending treatment at the end of life.
The most plausible cost-effectiveness estimate is much higher than what NICE normally considers an acceptable use of NHS resources. Therefore, trifluridine–tipiracil is not recommended for routine use in the NHS.
Further data collection is unlikely to change the cost-effectiveness estimate because the trial follow up is almost finished. Therefore, trifluridine–tipiracil is not recommended for use within the Cancer Drugs Fund.