title: Cost-effectiveness analysis of palivizumab among pre-term infant populations covered by Medicaid in the United States.
abstract: OBJECTIVE
  Medicaid infants are at high risk of severe respiratory syncytial virus (RSV) disease. The study objective was to estimate the cost-effectiveness of palivizumab in a Medicaid population.
  
  
  METHODS
  A societal cost-utility analysis was conducted of prophylaxis with palivizumab vs no prophylaxis among four groups of premature infants: (1) <32 weeks gestational age (wGA) and ≤ 6 months chronologic age (CA); (2) 32-34 wGA, ≤ 3 months CA with 2009 American Academy of Pediatrics (AAP) risk factors (RF); (3) 32-35 wGA, ≤ 6 months CA with 2006 AAP RF; and (4) 32-35 wGA, ≤ 6 months CA with ≤ 1 RF. Full dosing of palivizumab was assumed throughout the RSV season (consistent with the FDA-approved label). All costs were in 2010 US dollars. The societal public payer spend for palivizumab was estimated using Medicaid reimbursement methodologies for the top 10 palivizumab-using states in 2010 minus mandatory manufacturer rebates. This study reports the incremental cost-effectiveness ratios (ICERs) in cost per quality-adjusted life-year (QALY) gained. Sensitivity and probabilistic analyses were also conducted.
  
  
  RESULTS
  Palivizumab saved costs and improved QALYs among infants <32 wGA. Palivizumab was cost-effective in infants 32-34 wGA with 2009 AAP RF ($16,037 per QALY) and in infants 32-35 wGA with 2006 AAP RF ($38,244 per QALY). The ICER for infants 32-35 wGA with ≤ 1 RF was $281,892 per QALY. Influential variables in the sensitivity analysis included the background rate of RSV hospitalization, the cost of palivizumab, and the efficacy of palivizumab.
  
  
  CONCLUSIONS
  These results are not generalizable to commercially insured infants or infants outside of the US.
  
  
  CONCLUSIONS
  This is the first cost-utility analysis of palivizumab in a Medicaid population. Palivizumab, when dosed consistent with the FDA-approved labeling, was either cost-saving or cost-effective among current guideline-eligible infants in the Medicaid population. Palivizumab did not demonstrate cost-effectiveness in 32-35 wGA infants with ≤ 1 RF.
authors.affiliation: State University of New York, Upstate Medical University, Department of Pediatrics, Syracuse, NY, USA.
authors.forename: Leonard B
authors.initials: LB
authors.lastname: Weiner
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Masaquel
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Polak
authors.forename: Parthiv J
authors.initials: PJ
authors.lastname: Mahadevia
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use; D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D005865:Gestational Age; D006760:Hospitalization; D006801:Humans; D007231:Infant, Newborn; D019458:Insurance Coverage; D007362:Intensive Care Units; D008484:Medicaid; D018803:Models, Economic; D000069455:Palivizumab; D019057:Quality-Adjusted Life Years; D018357:Respiratory Syncytial Virus Infections / Q000150:complications / Q000517:prevention & control; D014481:United States
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D000069455:Palivizumab