This pharmacoeconomic analysis is based on data from a retrospective study, published in the Journal of Neonatal- Perinatal Medicine (Volume 4, Number 2, 2011). This previously-published study, based on data from Discovery Labs' two large phase 3 trials involving a total of 1546 patients, assessed the influence of reintubation on the risk of morbidity and mortality in preterm infants receiving surfactant therapy for the prevention of RDS, as well as the relative rates of reintubation between surfactant therapies. This article, the first published full description of the consequences of reintubation in a preterm neonate population, indicates that practitioners of neonatal medicine should choose therapeutic options that will optimize chances of successful extubation. This previously-published study concluded:
- Infants who were successfully extubated and did not require reintubation experienced a statistically significantly lower mortality rate across all treatment groups compared with infants who subsequently required reintubation (0.5 percent vs. 18 percent, respectively p<0.05).
- Infants who required reintubation had significantly higher rates of six major complications of prematurity, including BPD, necrotizing enterocolitis (a severe intestinal condition often requiring surgery and loss of bowel), sepsis, and intraventricular hemorrhage (bleeding into the brain).
- Nearly half of the infants requiring reintubation developed BPD, whereas only 15 percent of infants developed BPD if they were not reintubated ( p<0.05).
- Infants treated with SURFAXIN demonstrated a significantly lower reintubation rate compared with those infants treated with animal-derived surfactants Curosurf (33 percent vs. 47 percent respectively; p<0.05) and Survanta (35 percent vs. 43 percent respectively; p<0.05).
- Infants treated with SURFAXIN demonstrated a significantly higher combined outcome of survival without reintubation compared with those infants treated with animal-derived surfactants Curosurf (67 percent vs. 53 percent respectively; p<0.05) and Survanta (65 percent vs. 57 percent respectively; p<0.05).
- Initial extubation rates were similar among surfactant treatments in both trials (80 to 84 percent; p=ns)
Earlier this year, Discovery Labs reported results from its first pharmacoeconomic analysis based on this retrospective study, which focused on additional days of mechanical ventilation in reintubated infants. That analysis demonstrated that the lower rate of reintubation observed in infants treated with SURFAXIN resulted in a potential:
- Decreased costs related to direct hospital expenses associated with the need for extended mechanical ventilation due to reintubation.
- Hospital cost savings of approximately $160,000 to $252,000 per 100 infants when compared with infants treated with Curosurf and Survanta.
The first pharmacoeconomic analysis is expected to be published in the next issue of the Journal of Pediatric Pharmacology and Therapeutics (JPPT), a peer-reviewed multi-disciplinary journal that is devoted to promoting the safe and effective use of medications in infants and children.
In both pharmacoeconomic studies, authors noted that additional analyses investigating potential reduction in other reintubation-associated morbidities are warranted. As such, Discovery Labs is conducting a third analysis of the potential pharmacoeconomic impact of these complications and expects to report the results in 2013.