- Palivizumab, a humanized murine monoclonal immunoglobulin
- Standard dosing is 15 mg/kg administered intramuscularly every 30 days during RSV season for a maximum of five doses
Efficacy
- results of randomized controlled trials (RCTs) investigating palivizumab, demonstrating a reduction in hospitalizations of approximately
- 80% in infants with prematurity but without chronic lung disease of prematurity (CLD)
- 40% in infants with CLD
- 45% in children with congenital heart disease (CHD)
- Efficacy was not demonstrated in the CHD subgroup with cyanotic heart disease
- A recent systematic review summarized 20 published observational palivizumab studies and estimates of effectiveness were generally in the range predicted by the RCTs
Cost-Effectiveness
- Reports concerning the cost-effectiveness of palivizumab have varied, owing in large part to disparate estimates of its short- and long-term benefit
- Short-term benefits- there is no evidence that palivizumab prevents mechanical ventilation or death or that breakthrough RSV hospitalizations are less severe than hospitalizations in control
- Long term benefits - one RCT showed that palivizumab administered to infants 33 to 35 weeks’ GA without CLD decreased days with parent-reported wheezing in the first year from 4.5% to 1.8% (P<0.001; number needed to treat = 38) and decreased recurrent wheezing from 21% to 11% (P=0.01)
- Palivizumab prophylaxis has limited effect on RSV hospitalizations on a population basis, no measurable effect on mortality, and a minimal effect on subsequent wheezing
- technical review for the 2014 updated American Academy of Pediatrics (AAP) guidance for palivizumabprophylaxis indicates that palivizumab "cannot be considered as high-value health care for any group of infants" because its high cost is associated with minimal benefit
- Prophylaxis must be provided to many infants to prevent one hospitalization while the cost to provide prophylaxis to a single infant (approximately $5,600) exceeds that of a typical RSV hospitalization (three or four days).
Recommended Use
High Risk | Defination | Recommendation |
hemodynamically significant CHD or CLD | need for oxygen at 36 weeks’ GA, who require ongoing diuretics, bronchodilators, steroids or supplemental oxygen | · should receive palivizumab if they are <12 months of age at the start of RSV season. · not indicated during the second RSV season for infants with CHD · not indicated for majority of children with CLD (with the exception of those still on or weaned off of supplemental oxygen in the past three months) |
preterm infants without CLD | born before 30 + 0 weeks’ GA who are <6 months of age at the start of RSV season | · reasonable (but not essential) to offer palivizumab · Infants born after 30 + 0 weeks’ GA have RSV admission rates that are consistently ≤7% (90 doses of palivizumab to prevent one RSV admission) · not recommended in the second year of life on the basis of a history of prematurity alone |
preterm infants with CLD | gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least the first 28 days after birth | · Prophylaxis may be considered during the RSV season during the first year of life |
immunodeficiencies, Down syndrome, cystic fibrosis, upper airway obstruction or a chronic pulmonary disease other than CLD | · should not routinely be offered palivizumab However, prophylaxis may be considered for children <24 months of age who are on home oxygen, have had a prolonged hospitalization for severe pulmonary disease or are severely immunocompromised | |
pulmonary abnormality or neuromuscular disease | disease that impairs the ability to clear secretions from the upper airways | · No prospective studies or populationbased data are availabl · may be considered for prophylaxis during the first year of life (due to risk for a prolonged hospitalization related to lower respiratory tract infection) |
health care-associated RSV | prevention | · not recommended |
breakthrough RSV infection | breakthrough RSV infection during monthly palivizumab | · Continuation of monthly palivizumab is not recommended · Repeat RSV infections in one season are not common |
Recommendation
- Good hand hygiene in the home and avoiding contact of high-risk children with people with RTIs, where practical, remain paramount for RSV prevention.
- Breastfeeding and avoidance of exposure to cigarette smoke should be encouraged.
- Given that the efficacy of palivizumab is <50% in the highest-risk groups (CLD or CHD), and that most hospitalizations occur in healthy term infants, more education should be directed at such prevention strategies
- Based on lack of evidence that palivizumab prevents severe outcomes, palivizumab is unlikely to be cost-effective in children with prematurity, CLD or CHD, and can only be potentially cost-effective in settings where RSV hospitalizations are exceedingly common and very expensive
References:
- www.uptodate.com
- www.bestpractice.BMJ.com
- Preventing hospitalizations for respiratory syncytial virus infection. Canadian Paediatric Society Infectious Diseases and Immunization Committee Paediatr Child Health 2015;20(6):321-26. Updated: May 12 2016
- Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. PEDIATRICS Volume 134, Number 2, August 2014.
- Cost-effectiveness of palivizumab compared to no prophylaxis in term infants residing in the Canadian Arctic. cmajoOctober 18, 2016 vol. 4 no. 4 E623-E633
- A cost-effectiveness analysis of respiratory syncytial virus (RSV) prophylaxis in infants in the United Kingdom. Health Economics Review20133:18
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