Cost-Effectiveness Analysis of Poractant Alfa vs. Calfactant in the Management of Neonatal Respiratory Distress Syndrome in Tunisia
Author(s)
Amine Besbes, Pharm.D1, Rania Ben Hammamia, Pharm.D1, Ines Selmi, MD2, Hajer Felfel, Pharm.D1.
1Pharmacy Department, Mongi Slim University Hospital, La Marsa, Tunisia, 2Neonatology Department, Mongi Slim University Hospital, La Marsa, Tunisia.
1Pharmacy Department, Mongi Slim University Hospital, La Marsa, Tunisia, 2Neonatology Department, Mongi Slim University Hospital, La Marsa, Tunisia.
OBJECTIVES: This study aims to assess the cost-effectiveness of two natural surfactants—poractant alfa (porcine-derived) and calfactant (bovine-derived)—in the Tunisian population, to support evidence-based clinical and economic decision-making
METHODS: A retrospective, multicenter cost-effectiveness analysis was conducted from the healthcare provider’s perspective, involving 52 preterm infants—34 treated with poractant alfa and 18 with calfactant. Effectiveness was evaluated using clinical outcomes including duration of oxygen therapy, incidence of major complications (retinopathy of prematurity [ROP], intraventricular hemorrhage [IVH], and necrotizing enterocolitis [NEC]), survival to discharge, and length of hospital stay. Direct medical costs—covering medications, hospitalization, and diagnostic procedures—were estimated. A decision tree model was developed to simulate clinical pathways and outcomes. The incremental cost-effectiveness ratio (ICER) was calculated to determine the additional cost per clinical outcome gained.
RESULTS: Poractant alfa was associated with shorter durations of oxygen therapy (9.79 vs. 12.56 days) and hospitalization (21.06 vs. 28.78 days), although these differences did not reach statistical significance. However, poractant alfa significantly reduced the incidence of retinopathy of prematurity (ROP) (2.9% vs. 16.7%, p = 0.039) and intraventricular hemorrhage (IVH) (23.5% vs. 50%, p = 0.026) compared to calfactant.
The mean direct medical cost per patient was higher in the poractant alfa group: €1,420.02 (4,733.40 TND) versus €1,252.25 (4,174.16 TND), mainly driven by higher drug acquisition costs.
The incremental cost-effectiveness ratio (ICER) was €1,432.91 (4,776.37 TND) per case of ROP prevented and €746.20 (2,487.32 TND) per case of IVH prevented
CONCLUSIONS: Although associated with higher costs, poractant alfa resulted in significantly fewer severe neonatal complications. The observed ICERs suggest a favorable cost-effectiveness profile. These findings underscore the importance of context-specific pharmacoeconomic evaluations to inform evidence-based resource allocation in neonatal intensive care.
METHODS: A retrospective, multicenter cost-effectiveness analysis was conducted from the healthcare provider’s perspective, involving 52 preterm infants—34 treated with poractant alfa and 18 with calfactant. Effectiveness was evaluated using clinical outcomes including duration of oxygen therapy, incidence of major complications (retinopathy of prematurity [ROP], intraventricular hemorrhage [IVH], and necrotizing enterocolitis [NEC]), survival to discharge, and length of hospital stay. Direct medical costs—covering medications, hospitalization, and diagnostic procedures—were estimated. A decision tree model was developed to simulate clinical pathways and outcomes. The incremental cost-effectiveness ratio (ICER) was calculated to determine the additional cost per clinical outcome gained.
RESULTS: Poractant alfa was associated with shorter durations of oxygen therapy (9.79 vs. 12.56 days) and hospitalization (21.06 vs. 28.78 days), although these differences did not reach statistical significance. However, poractant alfa significantly reduced the incidence of retinopathy of prematurity (ROP) (2.9% vs. 16.7%, p = 0.039) and intraventricular hemorrhage (IVH) (23.5% vs. 50%, p = 0.026) compared to calfactant.
The mean direct medical cost per patient was higher in the poractant alfa group: €1,420.02 (4,733.40 TND) versus €1,252.25 (4,174.16 TND), mainly driven by higher drug acquisition costs.
The incremental cost-effectiveness ratio (ICER) was €1,432.91 (4,776.37 TND) per case of ROP prevented and €746.20 (2,487.32 TND) per case of IVH prevented
CONCLUSIONS: Although associated with higher costs, poractant alfa resulted in significantly fewer severe neonatal complications. The observed ICERs suggest a favorable cost-effectiveness profile. These findings underscore the importance of context-specific pharmacoeconomic evaluations to inform evidence-based resource allocation in neonatal intensive care.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA94
Topic
Clinical Outcomes, Economic Evaluation, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Pediatrics, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)