Passive immunisation of preterm infants with palivizumab against RSV infection

SummaryPalivizumab is a monocloncal antibody used for prevention of respiratory syncytial virus infection. This study reviews the literature regarding evidence of efficacy, safety and cost-effectiveness. The only randomised controlled trial into efficacy of palivizumab in preterm infants demonstrates clinical benefit and suggests a favourable safety profile. Further studies, however, do not provide evidence that costs saved by the reduction in hospitalisation would outweigh actual costs of the immunization for the recommended indications. There is considerable controversy over which groups of patients to include in immunization programs and analyses of cost-effectiveness are complicated by the fact that incidence of RSV infection, rates of hospitalisation and ventilation, health care costs and economic resources are variable among different health care systems and settings. Studies of cost-analysis, despite their implicit weaknesses, do not currently support the widespread use of palivizumab. In the absence of high quality cost-benefit analysis, we currently only recommend the use of palivizumab in infants at high risk of severe bronchiolitis, such as those with active chronic lung disease of prematurity. To illustrate current practice we also present data from an audit of the use of palivizumab in a regional centre in the North-East of England.