Trifluridine-tipiracil has failed to secure NICE approval for the treatment of metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after ≥2 systemic treatment regimens.
A NICE appraisal committee has reviewed clinical evidence from the phase 3 randomised controlled TAGS trial, which compared trifluridine-tipiracil plus best supportive care (BSC) against placebo and BSC in 507 adults with metastatic gastric cancer who had had at least two treatments for advanced disease.
The trial reported that, in the intention-to-treat cohort, trifluridine-tipiracil was associated with median overall survival (OS) of 5.7 months (95% CI 4.8-6.2) compared with 3.6 months (95% CI 3.1-4.1) with best supportive care (HR 0.69; 95% CI 0.56-0.85).
However, the committee had concerns regarding the generalisability of the full intention-to-treat analysis to the NHS in England. For example, a third of trial participants had had ramucirumab, which is not available in NHS England. Furthermore, 63% had had ≥3 previous treatments. This is estimated to be less than 5% in clinical practice in England.
Furthermore, the most plausible cost-effectiveness estimate was found to be above what NICE normally considers an acceptable use of NHS resources. Since further data is unlikely to change the cost-effectiveness estimates by much, the committee could not recommend trifluridine-tipiracil for this indication within the Cancer Drugs Fund.
NICE is inviting public comment on the draft decision. The closing date for receipt of comments is 24 January 2020.