Direct link to this page: http://www.hta.ac.uk/1596

Details of HTA project

Last updated: 15 July 2008 - Next update due: 22 July 2008


Research type:

HTA Technology Assessment Report  

Project title:

Immunoprophylaxis against RSV with palivizumab in children - A systematic review and economic evaluation 

Project ref:

06/29/01 

Cost:

This project has been commissioned by the HTA programme on a call-off contract basis. 

Chief Investigator :

West Midlands Health Technology Assessment Collaboration (WMHTAC), University of Birmingham

Start Date:

September 2006.  

Publication date:

October 2008. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed.  

Plain English Summary

Respiratory syncytial virus (RSV) is a very common infection in young children, with up to half of all infants becoming infected by the age of one. A proportion of children with RSV are seriously affected by the virus and may need to be hospitalised due 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 babies, 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 due to a weakened immune system. As many as one in five of these high risk infants may need to be hospitalised and some may require admission to an intensive care unit.
RSV is a seasonal disease, with epidemics occurring annually from October to March in the UK. Beyond supportive care (such as mechanical assistance with breathing, intravenous fluids and oxygen) the only treatment available for RSV infection is ribavirin. Ribavarin may be of some benefit after infection but its use requires hospitalisation which increases the risk of spreading the infection, it is costly and has a number of unwanted side effects. Strategies to prevent infection are therefore of considerable interest. Attempts to develop a vaccine to prevent RSV infection have so far been unsuccessful but another type of product, palivizumab (sold under the brand name of Synagis) which may be useful in preventing or reducing the severity of RSV infection is available for use in the UK. Common side effects of palivizumab include a reaction at the site of the injection and fever. Rare side effects, occurring in less than one in a hundred children, include infections, blood disorders, respiratory problems, rash, diarrhoea and vomiting.
Our report aims to address the best way for the health service to use palivizumab in children at high risk of developing serious complications following RSV infection. If clinical trials show that it is successful in reducing serious consequences of RSV in these children, the health service needs to know if these benefits are worthwhile given the cost of treating all such children before they become infected and the unpleasant consequences for the child, including the need for multiple injections and the side effects of the treatment. 

Abstract:

To estimate the cost-effectiveness of immunoprophylaxisof RSV using palivizumab (a monoclonal antibody) in different subgroups of children at high risk of serious morbidity from RSV infection.

Clinical outcomes include rate of hospitalisation, intensive care, mechanical ventilation, morbidity and mortality following RSV infection. Costs include the cost of prophylaxis with palivizumab including costs of administration, and cost of supportive care following RSV infection. Additional considerations include the need for multiple injections and side effects of treatment, dose and frequency of administration, reduction in risk of morbidity for infants who have previously been infected with RSV and long-term consequences of severe RSV infection such as chronic respiratory abnormalities and increased risk of developing asthma.

The National Coordinating Centre for HTA commissioned this technology assessment report on behalf of the HTA Programme Director.  

NRR* number, if applicable:

N0484190629 (*National Research Register) 

Project Protocol:

Project protocol (pdf format, 112 kbytes)

URL of this page:

http://www.hta.ac.uk/1596
Tue, 15 Jul 2008 15:19:45 +0100

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