Cost effectiveness of ethanol lock CLABSI prophylaxis
Introduction: Central line-associated bloodstream infections (CLABSIs) lead to significant morbidity and mortality in children with intestinal failure. Ethanol lock prophylaxis greatly reduces CLABSI frequency with minimal reported side effects. However, in the United States, a recently approved orphan drug designation for dehydrated alcohol has greatly increased the cost of 70% ethanol from an estimated $10/day to $1000/day. We examined the cost-effectiveness of ethanol lock prophylaxis in relation to these significant changes.
Methods: A previously developed Markov model of intestinal failure was simulated over 1 year. Costs were measured in 2020 US dollars and effectiveness in quality-adjusted life-years (QALYs). The primary outcome was incremental cost-effectiveness ratio (ICER) between treatments. Secondary outcomes include CLABSI frequency. Model parameters were based on the previously published model. CLABSI rate with and without ethanol lock prophylaxis was estimated from the largest available comparative observational study in the literature. Sensitivity analyses on all model parameters were performed. Discounting was applied at 3% per year for costs and QALYs.
Results: In the base model, children with intestinal failure not using ethanol lock therapy accumulated $131,815 in costs and 0.32 QALYs per patient. Using ethanol locks cost $437,884 and accumulated 0.33 QALYs per patient, or nearly $18 million/QALY gained compared to no locks. Ethanol locks resulted in a 40% reduction in CLABSI frequency. Ethanol lock prophylaxis became cost-effective at $68/day and cost-saving at $63/day. Sensitivity analysis identified no plausible variation of other parameters to reach the benchmark of $100,000/QALY gained. On probabilistic sensitivity analysis, 90% of iterations favored no ethanol locks at $100,000/QALY.
Conclusions: At the current price, ethanol lock therapy is not cost-effective for CLABSI prevention in children with intestinal failure in the United States. However, its cost prior to the recent orphan drug designation made it an economically reasonable choice. This study highlights the critical need for the approval of an affordable lock therapy option to prevent CLABSIs in these children.
Raghu V, Mezoff E, Cole C, Rudolph J, Smith K *O-34: Cost-effectiveness of Ethanol Lock Prophylaxis to Prevent Central Line-associated Bloodstream Infections in Children with Intestinal Failure in the United States. Transplantation. 2021 Jul 1;105(7S):S18. doi: 10.1097/01.tp.0000757604.96037.8f. PMID: 34792965.