Authors' objectives: The objective of this report is to identify the available evidence on effectiveness, safety and efficiency of the administration of palivizumab as prophylaxis of RSV infections in premature infants and through a own economic evaluation, estimate their efficiency in the context of Andalusian Public Health System. This report attempts to answer the following research questions: 1. Is administration of palivizumab to prevention of RSV infection in premature infants 6-12 months of age at the start of the RSV season with less than 29 weeks gestational age effective, safe and efficient? 2. Administration of palivizumab in premature infants of 32-35 weeks gestational age with risk factors: 2a. Is administration of palivizumab to prevention of RSV infection in premature infants of 32-35 weeks gestational age and 2 major risk factors (chronological age less than 10 weeks at the beginning of the RSV season or born in the first 10 weeks of it, have at least one brother in school-age or attends child care or go to child care) effective, safe and efficient? 2b. Is administration of palivizumab to prevention of RSV infection in premature infants of 32-35 weeks gestational age with 1 major and 2 minor risk factors (history of maternal smoking during pregnancy and male sex) effective, safe and efficient?

Authors' results and conclusions: 1. The localized evidence to study the effectiveness, safety and efficiency of palivizumab in the subgroups of preterm infants target has been poor. 2. More and higher quality studies are needed to recommend with high grade the palivizumab administration in infants less than 29 weeks gestational age with 6-12 months of age at the start of the RSV season and infants of 32-35 weeks gestational age with risk factors (two major risk factors; 1 major and 2 minor risk factors). Effectiveness and safety 3. Specific safety information about the target population of report has not been localized. Question 1 (< 29 weeks gestational age, 6-12 months of age at the start of the RSV season) 4. There is no scientific evidence to support the administration of palivizumab in premature infants less than 29 weeks gestational age with 6-12 months of age at the start of the RSV season to prevent RSV infection. Question 2a y 2 b (32-35 weeks gestational age with risk factors) 5. There is weak scientific evidence supporting the effectiveness of palivizumab in preterm infants of 32-35 weeks gestational age with risk factors (two major risk factors, 1 major and 2 minor risk factors), in terms of reduction of hospitalizations. A cohort study with some methodological limitations endorses the recommendation of palivizumab administration. Systematic review of effectiveness 6. The number of risk factors is a key elementin determining the efficiency of palivizumab in premature infants without heart or lung disease. The localized evidence suggests that at least two risk factors are needed for further study its efficiency. Question 1 (< 29 weeks gestational age, 6-12 months of age at the start of the RSV season) 7. The efficiency of palivizumab in premature infants less than 29 weeks gestational age and 6-12 months of age at the start of the RSV season, has been studied in a single study that concludes that it is not efficient, with ICUR well above the thresholds commonly accepted. Question 2a y 2 b (32-35 weeks gestational age with risk factors) 8. The efficiency of palivizumab in preterm infants of 32-35 weeks gestational age and two major risk factors has been collected in three studies. The results are very contradictory, so one can not say that prophylaxis is efficient in that case. 9. Scientific evidence about the efficiency of palivizumab in preterm infants of 32-35 weeks gestational age with 1 major and 2 risk factors has not been found. Own economic evaluation 10. The prophylactic use of palivizumab in preterm infants of 32-35 weeks gestational age with risk factors (two major risk factors; 1 major and 2 minor risk factors) in the context of SSPA can not be considered efficient under normal decision thresholds, with a figure of €867,994/QALY. 11.The deterministic sensitivity analysis carried out confirm that changes in the majority of the model variables, in any prophylaxis scenario with palivizumab is not an efficient strategy. 12. The probabilistic sensitivity analysis confirms that with a willingness to pay €30,000/QALY, palivizumab is not efficient in 99.97 % of cases. 13. The model performed, despite its limitations, is consistent with other previously studies not funded by industry, that support the conclusion number 10. 14. From own cost-effectiveness analysis, the cost per avoided hospitalization was €40,744.42. However, there are not thresholds to considerar if the intervention is or not efficient, in these terms. 15. The budget impact of the administration of palivizumab in this population in Andalusia is above 2.5 millions of euros per year.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/efectividad-seguridad-y-eficiencia-del-palivizumab-en-la-prevencion-de-la-infeccion-por-el-virus-respiratorio-sincitial-en-prematuros/

Year Published: 2014

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/2014_AETSA_Palivizumab_.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)