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Wang D, Bayliss S, Meads C. Palivizumab for Immunoprophylaxis of Respiratory Syncytial Virus (RSV) Bronchiolitis in High-Risk Infants and Young Children: Systematic Review and Additional Economic Modelling of Subgroup Analyses. Southampton (UK): NIHR Journals Library; 2011 Jan. (Health Technology Assessment, No. 15.5.)

Cover of Palivizumab for Immunoprophylaxis of Respiratory Syncytial Virus (RSV) Bronchiolitis in High-Risk Infants and Young Children: Systematic Review and Additional Economic Modelling of Subgroup Analyses

Palivizumab for Immunoprophylaxis of Respiratory Syncytial Virus (RSV) Bronchiolitis in High-Risk Infants and Young Children: Systematic Review and Additional Economic Modelling of Subgroup Analyses.

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2Background

As the original report has full details of the condition, current treatment options and information about palivizumab (Synagis®, MedImmune), only brief details will be given here.

Description of health problem

Respiratory syncytial virus is a seasonal infectious disease, with epidemics occurring annually from October to March in the UK. It is a very common infection in young children, with up to half of all infants becoming infected by the age of 1 year.1 A proportion of children with RSV are seriously affected by the virus and may need to be hospitalised owing to life-threatening complications such as bronchiolitis (inflammation of the smaller airways of the lung) and pneumonia. Children who are at high risk of hospitalisation for these reasons include premature infants, children with chronic lung disease due to abnormal development of the lungs or cystic fibrosis, children who were born with certain types of heart problems and children who have limited resistance to disease because of a weakened immune system.2 Many of these high-risk infants may need to be hospitalised and some may require admission to an intensive care unit.3

Detection of RSV in children with lower respiratory tract infections is by direct immunofluorescence assay, enzyme immunoassay or a positive viral culture for RSV from nasopharyngeal secretions.

Current service provision

Beyond supportive care (such as mechanical assistance with breathing, intravenous fluids and oxygen), the only treatment available for severe RSV infection causing bronchiolitis is ribavirin (Virazole®, ICN Pharmaceuticals).4 This is an antiviral treatment available orally and by inhalation. It is licensed for inhaled administration for severe bronchiolitis caused by RSV infection in infants, especially when they have other serious conditions, such as when they are immunocompromised. However, ‘there is no evidence that ribavirin produces clinically relevant benefit in RSV bronchiolitis’.4 Its use requires hospitalisation, which increases the risk of spreading the infection, and it is costly and has a number of unwanted side effects.4

Attempts to develop a vaccine to prevent RSV infection have so far been unsuccessful. Strategies to prevent infection are therefore of considerable interest.

Description of technology under assessment

Palivizumab has a proprietary name of Synagis®. It is a monoclonal antibody and is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease.4 It is used in the following high-risk groups:

  • children < 6 months with haemodynamically significant left to right shunt, congenital heart disease (CHD) or pulmonary hypertension
  • children < 2 years with chronic lung disease requiring oxygen at home (or who have been on prolonged oxygen treatment)
  • children < 2 years with severe congenital immunodeficiency
  • children born at 35 weeks of gestation or less and < 6 months of age at the onset of the RSV season and considered to be at high risk of RSV hospitalisation.4

Common side effects of palivizumab include injection site reactions, nervousness and fever. Less common side effects include diarrhoea and vomiting, constipation, haemorrhage, rhinitis, respiratory problems, pain, drowsiness, asthenia, hyperkinesia, leucopenia and rash.4

The recommended dose of palivizumab is 15 mg per kg body weight, injected intramuscularly, given once a month during anticipated periods of RSV risk in the community. Where possible, the first dose should be administered prior to commencement of the RSV season. Subsequent doses should be administered monthly throughout the RSV season. To reduce the risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.4

For children undergoing cardiac bypass, it is recommended that a 15 mg/kg injection of palivizumab be administered as soon as the child is stable after surgery to ensure adequate palivizumab serum levels. Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease.

The cost of palivizumab (Synagis®) is £360.00 for a 50-mg vial and £663.11 for a 100-mg vial.4 If a baby at 6 months weighs 7.5 kg the cost of one dose of palivizumab is £1023.11 if vial wastage is assumed, plus cost of administration.

© 2011, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK109540

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