Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing acute respiratory infections, resulting in about 3.4 million hospitalisations annually in children under five. Palivizumab is the only product approved for prevention of serious RSV disease, as motavizumab is no longer being developed for this condition. The efficacy and safety of palivizumab has been evaluated in randomized controlled trials (RCTs) and a large number of economic evaluations (EEs) have tested its cost‐effectiveness.

To assess the effectiveness and safety of palivizumab prophylaxis in reducing the risk of complications (hospitalization due to RSV infection) in high‐risk infants and children. To assess the cost‐effectiveness (or cost‐utility) of palivizumab prophylaxis in infants and children in different risk groups.

We searched CENTRAL (2012, Issue 7), MEDLINE (1996 to July week 4, 2012), EMBASE (1996 to August 2012), CINAHL (1996 to August 2012) and LILACS (1996 to August 2012) for RCTs. We searched the NHS Economic Evaluations Database (NHS EED 2012, Issue 4), Health Economics Evaluations Database (HEED, 9 August 2012), Paediatric Economic Database Evaluations (PEDE, 1980 to 2009), MEDLINE (1996 to July week 4, 2012) and EMBASE (1996 to August 2012) for EEs.

We included RCTs comparing palivizumab prophylaxis with a placebo or another type of prophylaxis in preventing serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. We included cost‐effectiveness analyses and cost‐utility analyses comparing palivizumab prophylaxis with no prophylaxis.

Two review authors independently assessed risk of bias for the included studies and extracted data for both the RCTs and EEs. We calculated risk ratios (RRs) and their associated 95% confidence intervals (CIs) for dichotomous outcomes and for adverse events (AEs). For continuous outcomes, we provided a narrative summary of results due to missing data on standard deviations. We performed fixed‐effect meta‐analyses for the estimation of pooled effects whenever there was no indication of heterogeneity between included RCTs.

We summarised the results reported in included EEs, such as incremental costs, incremental effectiveness, and incremental cost‐effectiveness and/or cost‐utility ratios (ICERs), and we calculated ICER present values in 2011 Euros for all studies.

Of the seven available RCTs, three compared palivizumab with a placebo in a total of 2831 patients, and four compared palivizumab with motavizumab in a total of 8265 patients. All RCTs were sponsored by the drug manufacturing company. The overall quality of RCTs was good, but most of the outcomes assessed relied on data from only two studies. Palivizumab prophylaxis was associated with a statistically significant reduction in RSV hospitalisations (RR 0.49, 95% CI 0.37 to 0.64) and a statistically non‐significant reduction in all‐cause mortality (RR 0.69, 95% CI 0.42 to 1.15) when compared to placebo. When compared to motavizumab, palivizumab recipients showed a non‐significant increase in the risk of RSV hospitalisations (RR 1.36, 95% CI 0.97 to 1.90) and a non‐significant risk reduction in all‐cause mortality (RR 0.74, 95% CI 0.38 to 1.43). In both cases, the proportion of children with any AE or any AE related to the study drug was similar between the two groups.

We included 34 studies that reported cost‐effectiveness and/or cost‐utility data for palivizumab prophylaxis in high‐risk children with different underlying medical conditions. The overall …