Economic evaluation of tranexamic acid for the treatment of acute gastrointestinal bleeding: a cost-effectiveness analysis using data from the HALT-IT randomised controlled trial

<jats:sec><jats:title>Objective</jats:title><jats:p>To perform an economic evaluation of tranexamic acid (TXA) versus no-TXA, in addition to current clinical practice, for acute gastrointestinal bleeding, using the results of the HALT-IT trial (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01658124">NCT01658124</jats:ext-link>), a large randomised controlled trial which included 11 937 patients.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A cost-effectiveness modelling analysis, performed over a lifetime time horizon.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>The analysis was performed from a UK health service perspective.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>The model includes adults with acute gastrointestinal bleeding.</jats:p></jats:sec><jats:sec><jats:title>Outcomes measures</jats:title><jats:p>The model reports costs in Great British pounds in 2021 and outcomes as life years (LYs) and quality-adjusted life years (QALYs). Cost-effectiveness was evaluated using incremental cost-effectiveness ratios (ICERs), reported as the cost per QALY gained.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A Markov model was developed to calculate the overall costs and health outcomes of TXA administration versus no-TXA. The model used data of the treatment effectiveness from the HALT-IT trial, which showed that TXA administration for acute gastrointestinal bleeding did not reduce all-cause mortality (risk ratio 1.03, 95% CI 0.92 to 1.16) compared with no-TXA. Data on health-related quality of life, costs and long-term mortality risks were derived from the literature. Costs and effects are discounted at 3.5% per annum.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>TXA was associated with marginally fewer LYs and QALYs, and lower costs, than treatment without TXA. The ICER associated with no-TXA was £1576 per LY gained and £2209 per QALY gained. No-TXA was 64% likely to be cost-effective at a £20 000 willingness-to-pay threshold, while TXA was 36% likely to be cost-effective.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Though inexpensive, TXA administration for patients with acute gastrointestinal bleeding is unlikely to be cost-effective.</jats:p></jats:sec>