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.
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.
In a multivariate analysis, annual mean per participant costs were significantly lower between those receiving IGIV-C compared with IGIV-SD for prescription medications [–$302, 95% confidence interval (CI) –$598 to –$6], hospitalization (–$1454, 95% CI –$1828 to –$1080) and total costs (–$1304, 95% CI –$1867 to –$742). 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.
IGIV-C is cost-saving compared with IGIV-SD among persons with PIDD.