title: Cost savings from intravenous immunoglobulin manufactured from chromotography/caprylate (IGIV-C) in persons with primary humoral immunodeficiency disorder.
abstract: OBJECTIVE
  Human intravenous immunoglobulin manufactured with chromatography and caprylate methods (IGIV-C, 10%) was associated with a reduction in validated infections (pneumonia and sinusitis) compared with treatment with a licensed immunoglobulin product manufactured using standard solvent-detergent methods (IGIV-SD, 10%) in participants with primary humoral immunodeficiency disorder (PIDD). Our objective was to determine the cost-consequences of using IGIV-C instead of IGIV-SD.
  
  
  METHODS
  Economic analysis of a double-blind, randomized, clinical trial was used. Participants were randomly assigned to IGIV-C (N = 87) or IGIV-SD (N = 85) and monitored for the development of validated infections over the course of 9 months. Consumed resources were enumerated including cost of physician and emergency room visits, medications (prescription and over-the-counter), work productivity losses, and hospitalizations. Resource data was obtained from case report forms, patient diaries and the trial medication database. Because the amount of IGIV-SD used exceeded that of IGIV-C (nonstatistically significant difference) and the products are equivalently priced, we conservatively excluded investigational product acquisition cost to avoid artificially biasing incremental cost differences. We used a societal perspective with indirect costs, measured in 2003 US dollars. Pricing of both IGIV products is anticipated to be equivalent.
  
  
  RESULTS
  In a multivariate analysis, annual mean per participant costs were significantly lower between those receiving IGIV-C compared with IGIV-SD for prescription medications [-US 302 dollars, 95% confidence interval (CI) -US 598 dollars to -US 6 dollars], hospitalization (-US 1454 dollars, 95% CI -US 1828 dollars to -US 1080 dollars) and total costs (-US 1304 dollars, 95% CI -US 1867 dollars to -US 742 dollars). Costs associated with lost work productivity and physician visits were similar in both groups (P > 0.10). In sensitivity analyses, varying costs of concomitant medications, hospitalization and outpatient care, did not significantly change our results.
  
  
  CONCLUSIONS
  IGIV-C is cost-saving compared with IGIV-SD among persons with PIDD.
authors.affiliation: MEDTAP International Inc., Bethesda, MD 20814, USA.
authors.forename: Parthiv J
authors.initials: PJ
authors.lastname: Mahadevia
authors.forename: John
authors.initials: J
authors.lastname: Strell
authors.forename: Dan
authors.initials: D
authors.lastname: Kunaprayoon
authors.forename: Erwin
authors.initials: E
authors.lastname: Gelfand
mesh_terms: D000328:Adult; D002170:Canada; D002210:Caprylates; D002845:Chromatography; D017046:Cost Savings; D017281:Cost of Illness; D004340:Drug Contamination / Q000191:economics / Q000517:prevention & control*; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000191:economics; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy* / Q000191:economics; D016013:Likelihood Functions; D008297:Male; D017059:Models, Econometric; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic; D012141:Respiratory Tract Infections / Q000191:economics / Q000517:prevention & control*; D012189:Retrospective Studies; D013678:Technology, Pharmaceutical / Q000191:economics*; D014481:United States
chemical_list: D002210:Caprylates; D016756:Immunoglobulins, Intravenous