Authors' objectives:

This review aims to systematically review the scientific evidence about the effectiveness and cost-effectiveness of palivizumab for the prevention RSV in children and see whether we can identify subgroups in whom palivizumab is costeffective.

Authors' results and conclusions: Clinical effectivenessTwo RCTs were identified. Prophylaxis with palivizumab for preterm infants without CLD or children with CLD resulted in a 55% reduction in RSV hospital admission: 4.8% (48/1002) in palivizumab and 10.6% (53/500) in no prophylaxis groups (P= 0.0004). Prophylaxis with palivizumab was associated with a 45% reduction in RSVhospitalisation rate for children with CHD. RSV-hospitalisation rates were 5.3% (34/639) in the palivizumab group and 9.7% (63/648) in the no prophylaxis group (p=0.003). Both RCTs had a slightly higher mortality in the control group but this was not statistically significant. However the trials were not powered to demonstrate a difference. Palivizumab had a relatively safe adverse event profile.

Authors' recommendations: Prophylaxis with palivizumab is clinically effective for the reducing the risk of serious LRTI caused by RSV infection and requiring hospitalisation in high-risk children but does not represent good value for money if used indiscriminately in the licensed population. The BrumEE shows that prophylaxis with palivizumab may be costeffective for children with CLD when the children have two or more additional risk factors. Our economic evaluation is limited by the quality and quantity of the primary data available and the pragmatic rather than systematic methods used to identify parameter values. Future research should initially focus on reviewing systematically the major uncertainties for patient subgroups with CLD and CHD (e.g. mortality rates for RSV infection in children not given palivizumab prophylaxis) and then on primary research to address the important uncertainties that remain.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.birmingham.ac.uk/Documents/college-mds/haps/projects/WMHTAC/REPreports/2007/Palivizumab.pdf

Year Published: 2007

URL for published report: http://www.birmingham.ac.uk/research/activity/mds/projects/HaPS/PHEB/WMHTAC/REP/reports-list.aspx

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: West Midlands Health Technology Assessment Collaboration

Contact Address: Elaena Donald-Lopez, West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT Tel: +44 121 414 7450; Fax: +44 121 414 7878

Contact Name: louise.a.taylor@bham.ac.uk

Contact Email: louise.a.taylor@bham.ac.uk

Copyright: West Midlands Health Technology Assessment Collaboration (WMHTAC)