Prospective economic evaluation ancillary to a trial of higher versus lower hemoglobin transfusion thresholds for preterm infants

BACKGROUND: The Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants randomized trial compared higher versus lower hemoglobin transfusion thresholds in extremely low birth weight infants. This publication compares the economic implications of the two strategies. DESIGN/METHODS: We undertook a prospectively-planned economic evaluation, using patient level data from the parent clinical trial. We report costs in 2020 United States dollars, from health sector and modified societal perspectives, with a time horizon through the end of clinical follow-up. We derived costs from hospital finance systems, Medicaid fee schedules, and family questionnaires, and efficacy from trial data. RESULTS: Of the 1824 patients enrolled in the trial in 19 centers, data were available for 1305 for analysis from a health sector perspective, and 752 for analysis from a societal perspective. The mean cost from the health sector perspective was USD 331,186 per patient in the higher hemoglobin transfusion threshold group and USD 351,579 in the lower hemoglobin transfusion threshold group; the difference was not statistically significant after adjustment for study site and birth weight stratum (p=0.085). The mean costs from the societal perspective were also not statistically significant (p=0.094). The incremental cost-effectiveness ratios for adoption of a lower tranfusion threshold from health sector and societal perspectives were USD 6,797,666 and USD 5,596,666 per additional survivor without NDI, respectively. There was substantial uncertainty in these cost-effectiveness estimates. CONCLUSIONS: Similarly to prior results for clinical efficacy, choosing between a lower or higher hemoglobin transfusion threshold for extremely preterm infants has no significant economic advantage.