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| - Abstract Background: The Intercept Blood System (IBS) for platelets has been developed to reduce pathogen transmission risks during transfusions. Objective: This study was a comprehensive economic analysis of the cost-effectiveness of using the IBS for single-donor apheresis platelets (AP) and random-donor pooled platelet concentrates (PC) versus AP and PC without the IBS in the United States in patient populations in which platelets are commonly transfused. Methods: All data used in this analysis were summarized from existing published sources (primarily indexed in MEDLINE) and data on file at Baxter Healthcare Corporation (Chicago, Illinois) and Cerus Corporation (Concord, California). A literature-based decision-analytic model was developed to assess the economic costs and clinical outcomes associated with the use of AP and PC treated with the IBS for several conditions and procedures that account for a considerable proportion of the platelet usage in the United States: acute lymphocytic leukemia, non-Hodgkin's lymphoma, coronary artery bypass graft, and hip arthroplasty Risks of infection with HIV, hepatitis C virus (HCV), hepatitis B virus, human T-cell lymphotropic virus type 1, or bacterial agents were incorporated into the model. Possible benefits of reduction of the risk of emerging HCV like pathogens and elimination of the need for gamma irradiation were explored in sensitivity analyses. Results: The incremental cost per quality-adjusted life-year gained by using AP + IBS versus untreated AP ranged from $1,308,833 to $4,451,650 (without bacterial testing) and $4,759,401 to $22,968,066 (with bacterial testing). Corresponding figures for PC + IBS versus untreated PC ranged from $457,586 to $1,816,060. Inclusion of emerging HCV like virus and the elimination of the need for gamma irradiation improved the cost-effectiveness to a range of $177,695 to $1,058,127 for AP without bacterial testing, $176,572 to $1,330,703 for AP with bacterial testing, and $22,888 to $153,564 for PC. The model was most likely to be affected by mortality from bacterial contamination, IBS effect on platelet utilization, and the inclusion of potential benefits (ie, gamma irradiation and/or emergent HCVlike virus). The model was relatively insensitive to changes in the IBS price and viral transmission risks. Conclusions: The cost-effectiveness of pathogen inactivation via the IBS for platelets is comparable to that of other accepted blood safety interventions (eg, nucleic acid amplification technology). The IBS for platelets may be considered a desirable strategy to increase the safety of platelet transfusions and a potential insurance against the threat of emerging pathogens.
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