title: Pharmacokinetics - Neonatal Intensive Care Drug Manual
text: Pharmacokinetics
  A modelled pharmacokinetic study [11] of palivizumab data from 22 clinical studies reported Palivizumab clearance increased slightly from 10.2 ml/day to 11.9 ml/day as a function of postnatal age ranging from 7 to 18 months. Covariate analysis indicated 20% higher clearance in children with chronic lung disease and in children with antidrug antibody titer values >80. Body weight-based dosing of 15 mg/kg yielded similar palivizumab concentrations in children of different gestational and postnatal ages. There was little difference in palivizumab PK between healthy term and premature infants. Simulations found the 5 monthly palivizumab doses of 15 mg/kg, used in 2 RCTs, provided greater and more prolonged palivizumab exposure than did an abbreviated dosing regimen of 3 monthly doses.
  Cost
  Results from economic evaluations of palivizumab prophylaxis are inconsistent across studies, ranging from highly cost-effective to not cost-effective, implying that economic findings must be interpreted with caution. [2]
  The average cost of 5 doses of palivizumab for a full term male infant < 1 year, based on the 50th centile for weight, is likely to be approximately $9,323 (drug cost only, excluding outpatient clinic costs), and $14,560 for a patient between 1-2 years. For a patient on the 3rd centile, the average estimated cost is $8,385 < 1 year, and $11,806 between 1-2 years. [9] Estimated bed saving for infant age <1 year age is 3.4 days and for an infant 1 to 2 years age is 2.5 days. If bed cost is assumed to be a maximum average $3500 per day, then one admission saved results in a $11900 to $8750 hospital cost saving. Estimated pharmaceutical only cost of treatment is below:
  Population
  |
  RSV related admission rate per 100000
  |
  NNT to prevent one RSV related admission
  |
  Cost palivizumab per admission averted 50th centile <1 year $9,323; 1-2 years $14,560 [9]
  |
  Cost palivizumab per admission averted 3rd centile <1 year $8,385; 1-2 years$11,806 [9]
  |
  Infants with CLD 0 to <6 months age [9]
  |
  56250
  |
  4
  |
  37292
  |
  33540
  |
  Infants with CLD 6 to <12 months age [9]
  |
  21430
  |
  9
  |
  83907
  |
  75465
  |
  Infants with CLD 12 to <24 months age [9]
  |
  7340
  |
  27
  |
  393120
  |
  318762
  |
  ≤26 weeks gestation [9]
  |
  13900
  |
  14
  |
  130522
  |
  117390
  |
  Infants with CHD 0 to <6 months [9]
  |
  12080
  |
  17
  |
  158491
  |
  142545
  |
  Infants with CHD 6 to <12 months [9]
  |
  6350
  |
  32
  |
  298336
  |
  268320
  |
  Other condition* 0 to <6 months [9]
  |
  2230
  |
  16
  |
  149168
  |
  134160
  |
  Colour coding: Orange <$150000 per treatment course; green <$100000 per treatment course
  * Asthma, cystic fibrosis, cancer, HIV infection, immunodeficiency, steroid therapy, chronic renal disease, diabetes mellitus, congenital anomalies of the respiratory tract, or respiratory distress syndrome.
  |