1.
Economic Analyses of Pathogen-Reduction Technologies in Blood Transfusion: A Systematic Literature Review
LaFontaine PR, Yuan J, Prioli KM, Shah P, Herman JH, Pizzi LT
Applied health economics and health policy. 2021
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Abstract
BACKGROUND Technologies used in the processing of whole blood and blood component products, including pathogen reduction, are continuously being adopted into blood transfusion workflows to improve process efficiencies. However, the economic implications of these technologies are not well understood. With the advent of these new technologies and regulatory guidance on bacterial risk-control strategies, an updated systematic literature review on this topic was warranted. OBJECTIVE The objective of this systematic literature review was to summarize the current literature on the economic analyses of pathogen-reduction technologies (PRTs). METHODS A systematic literature review was conducted using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines to identify newly published articles in PubMed, MEDLINE Complete, and EconLit from 1 January 2000 to 17 July 2019 related to economic evaluations of PRTs. Only full-text studies in humans published in English were included in the review. Both budget-impact and cost-effectiveness studies were included; common outcomes included cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS The initial searches identified 433 original abstracts, of which 16 articles were included in the final data extraction and reporting. Seven articles presented cost-effectiveness analyses and nine assessed budget impact. The introduction of PRT increased overall costs, and ICER values ranged widely across cost-effectiveness studies, from below $US150,000/QALY to upwards of $US20,000,000/QALY. This wide range of results was due to a multitude of factors, including comparator selection, target patient population, and scenario analyses included. CONCLUSIONS Overall, the results of economic evaluations of bacterial risk-control strategies, regardless of mechanism, were highly dependent on the current screening protocols in place. The optimization of blood transfusion safety may not result in decisions made at the willingness-to-pay thresholds commonly seen in pharmaceutical evaluations. Given the critical public health role of blood products, and the potential safety benefits introduced by advancements, it is important to continue building this body of evidence with more transparency and data source heterogeneity. This updated literature review provides global context when making local decisions for the coverage of new and emerging bacterial risk-control strategies.
PICO Summary
Population
Whole blood and blood component products (16 studies).
Intervention
Systematic review to summarize the current literature on the economic implications of pathogen-reduction technologies (PRTs).
Comparison
Outcome
The introduction of PRT increased overall costs, and incremental cost-effectiveness ratios values ranged widely across cost-effectiveness studies, from below $US150,000/quality-adjusted life-years (QALY), to upwards of $US20,000,000/QALY. This wide range of results was due to a multitude of factors, including comparator selection, target patient population, and scenario analyses.
2.
Economic consequences of alterations in platelet transfusion dose: analysis of a prospective, randomized, double-blind trial
Ackerman SJ, Klumpp TR, Guzman GI, Herman JH, Gaughan JP, Bleecker GC, Mangan KF
Transfusion. 2000;40((12):):1457-1462.
3.
Clinical consequences of alterations in platelet transfusion dose: a prospective, randomized, double-blind trial
Klumpp TR, Herman JH, Gaughan JP, Russo RR, Christman RA, Goldberg SL, Ackerman SJ, Bleecker GC, Mangan KF
Transfusion. 1999;39((7):):674-681.
4.
Comparison of two preservation solutions for erythrocyte transfusions in newborn infants
Goodstein MH, Locke RG, Wlodarczyk D, Goldsmith LS, Rubenstein SD, Herman JH
Journal of Pediatrics. 1993;123((5):):783-8.
Abstract
To determine whether one of the newer preservation solutions for packed red blood cells (PRBC) is safe and effective in the transfusion of the very low birth weight infant, we conducted a randomized trial comparing PRBC preserved with the anticoagulant solution mannitol-adenine-dextrose (AS-1) and PRBC preserved with citrate-phosphate-dextrose-adenine (CPDA-1). Sixteen infants (birth weight 863 +/- 218 gm) with a gestational age of 26 +/- 3 weeks received one to three small-volume replacement transfusions with PRBC, 17 ml/kg, preserved with either AS-1 or CPDA-1 in a double crossover design. Transfusion with AS-1-preserved PRBC resulted in an equivalent increase in hemoglobin concentration when adjustment was made for the difference in the hemoglobin concentration of the transfused PRBC. During the transfusion, the percentage decrease in serum glucose values was greater with the CPDA-1 preservative than with the AS-1 preservative (54% +/- 13% vs 42% +/- 11% at 1 hour; p < 0.001). No other significant difference in blood chemistry values was found. Urine output was unaffected by AS-1 in the posttransfusion period. We conclude that (1) small-volume PRBC transfusions with AS-1 can be used in the very low birth weight infant without apparent detriment, (2) AS-1-preserved cells are as effective as cells preserved with CPDA-1 for increasing hemoglobin concentration, and (3) the higher dextrose content of the AS-1-preserved blood allows for improved glucose homeostasis during transfusion.
5.
A randomized, placebo-controlled trial of intravenous gammaglobulin in alloimmunized thrombocytopenic patients
Kickler T, Braine HG, Piantadosi S, Ness PM, Herman JH, Rothko K
Blood. 1990;75((1):):313-6.
Abstract
In a placebo-controlled, randomized blinded study, we evaluated the efficacy of intravenous gammaglobulin (IV-IgG) in alloimmunized thrombocytopenic patients. IV-IgG was administered at a dose of 400 mg/kg for 5 days. An incompatible platelet transfusion from the same donor was used before and after treatment. Seven patients received IV-IgG and five patients received placebo. Although platelet recovery in 1 to 6 hours was satisfactory in five patients after IV-IgG treatment, 24-hour survival was not improved in most patients. None of the patients receiving the placebo achieved satisfactory 1-hour platelet-corrected count increments (CCIs). By t test, the posttreatment mean values 1 hour after transfusion CCIs in the IV-IgG group were significantly greater than in the control group (8,413 v 1,050, P less than .007). Using a regression model to adjust for any distributional assumptions of the study population, the parameter estimate for IV-IgG treatment was positive, indicating that IV-IgG treatment is associated with higher CCIs. Although IV-IgG may improve 1-hour platelet recovery, clinical benefit was not demonstrated since 24-hour survival was not improved. IV-IgG treatment before unmatched platelet transfusions should not be considered as a replacement for HLA-compatible platelets in alloimmunized patients.
6.
Negative result: treatment of patients with rheumatoid arthritis with gamma globulin: a double-blind controlled study
Herman JH, Jasin HE, Smiley JD, Ziff M
Arthritis & Rheumatism. 1969;12((5):):515-9.