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New HTA Decisions in England
January 2021
Drug name
LONSURF® (trifluridine–tipiracil)
Decision date
Therapeutic area
Therapeutic sub area
Not recommended
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.
Decision Detail
A phase 3 randomised controlled trial (TAGS) provided the clinical evidence for trifluridine–tipiracil, comparing trifluridine–tipiracil and best supportive care with placebo and best supportive care in adults with metastatic gastric cancer who had had at least 2 treatments for advanced disease, and who had an ECOG performance score of 0 or 1. Based on the evidence presented, the committee was not convinced that trifluridine–tipiracil provided an adequate survival benefit and concluded that trifluridine–tipiracil did not meet the extension-to-life criterion, and therefore could not be considered a life-extending treatment at the end of life. The committee concluded that all ICERs, including the most plausible ICER based on its preferred assumptions, were substantially higher than £30,000 per QALY gained. Therefore, trifluridine–tipiracil could not be 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.