Fish oil lipid emulsion compared with soybean oil lipid emulsion in pediatric patients with parenteral nutrition-associated cholestasis: A cost-effectiveness study

Objectives: Evidence indicates that, in pediatric patients with parenteral nutrition-associated cholestasis (PNAC), the use of a 100% fish oil lipid emulsion (FOLE) increased the likelihood of PNAC resolution and reduced the likelihood of liver transplantation compared with a 100% soybean oil lipid emulsion (SOLE). To evaluate the potential economic benefit, we conducted a cost-effectiveness analysis comparing FOLE with SOLE.

Study design: A discrete event simulation model evaluated cost-effectiveness by simulating clinical outcomes and estimating associated healthcare costs in pediatric patients with PNAC receiving parenteral nutrition (PN) with FOLE (1 g/kg) or SOLE (1.9 g/kg) over a time horizon of 6 years. Model inputs for clinical outcomes were derived from the integrated analysis of two US Phase 3 trials (NCT00910104 and NCT00738101). Cost estimates were estimated from the perspective of the US payer including the cost of PN, transplantation, and adverse events.

Results: The total cost associated with FOLE was $69,847 USD vs $141,605 USD for SOLE. The cost reduction of $71,757 USD was attributable to the avoidance of liver transplantation (-15.7%) and reduction in adverse events (-4.8%). Life-years and the quality-adjusted life-years were increased with FOLE compared with SOLE (by 0.248 and 0.295, respectively).

Conclusion: By reducing the need for liver transplant and providing time to transition to full enteral nutrition, FOLE leads to cost-savings, compared with SOLE, in pediatric patients with PNAC in the perspective of the US payer. These findings support the use of FOLE in pediatric patients with PNAC who require PN.