title: Cost effectiveness of palivizumab in children with congenital heart disease in Germany.
abstract: OBJECTIVE
  To assess the cost effectiveness of palivizumab, a humanised monoclonal antibody, used as prevention against severe respiratory syncytial virus (RSV) infection requiring hospitalisation, in infants with haemodynamically significant congenital heart disease (CHD) in the German healthcare setting.
  
  
  METHODS
  A decision-tree model was used to estimate the cost effectiveness of palivizumab for a hypothetical cohort of patients. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. Data sources included published literature, the palivizumab pivotal trials, official price/tariff lists and national population statistics. The study was conducted from the perspective of society (primary analysis) and the healthcare purchaser (secondary analysis).
  
  
  RESULTS
  From the societal perspective, use of palivizumab results in an incremental cost-effectiveness ratio (ICER) of €2,615 per quality-adjusted life-year (QALY) without discounting, which increases to €9,529/QALY after discounting. From the perspective of the German healthcare purchaser, use of palivizumab results in an ICER of €4,576/QALY without discounting, which increases to €16,673/QALY after discounting. Probabilistic sensitivity analyses confirmed the robustness of the model. The study is limited by a number of conservative assumptions. It was assumed that palivizumab only affects the occurrence of RSV hospitalisation and does not influence the severity of the RSV infection. Another assumption was that international clinical trial data and data on utilities could be applied to the German healthcare setting.
  
  
  CONCLUSIONS
  This analysis showed that palivizumab represents a cost-effective means of prophylaxis against severe RSV infection requiring hospitalisation in infants with haemodynamically significant CHD.
authors.affiliation: Erasmus University, Rotterdam, The Netherlands. nuijten@bmg.eur.nl
authors.forename: Mark
authors.initials: M
authors.lastname: Nuijten
authors.forename: Maximilian
authors.initials: M
authors.lastname: Lebmeier
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Wittenberg
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000191:economics*; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D005858:Germany; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006330:Heart Defects, Congenital / Q000188:drug therapy / Q000191:economics* / Q000821:virology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D017059:Models, Econometric; D000069455:Palivizumab; D019057:Quality-Adjusted Life Years; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy / Q000191:economics* / Q000517:prevention & control*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D000069455:Palivizumab