Reason for request
The actual benefit of this proprietary medicine must therefore be considered to be low.
Clinical Added Value
Taking into account the choice of primary efficacy endpoint for the clinical studies and after reviewing the descriptive data of the observational study, the Transparency Committee considers that SYNAGIS only provides a minor improvement in the actual benefit (level IV) of treatment strategy of :
- infants under 6 months of age at the start of the epidemic season, born at 32 weeks of gestation or before and at high risk because of respiratory sequelae for whom severity isshown by an oxygen requirement > 28 days after birth ;
- children aged under 2 years at the start of the epidemic season, born at 32 weeks of gestation or before, at high risk because of respiratory sequelae for whom severity is shown by an oxygen requirement > 28 days after birth and requiring treatment for bronchopulmonary dysplasia within the last 6 months ;
- children aged under two years with haemodynamically significant congenital heart disease as defined by the Paediatric Cardiology section of the French Cardiology Society.