Coagulation and Transfusion Medicine / UTILIZATION OF COAGULATION FACTORS

Coagulation factor replacement can effectively treat or prevent most hemophilia complications, but it is expensive. Although published data describe how to achieve therapeutic goals through cost-effective selection and dosing of replacement products, criteria are not universally known or followed. A review of our institution’s experience revealed overdosing of coagulation factors in the majority of patients treated during a 12-month period, at a cost that approached $700,000. Consequently, we established mandatory clinical pathology consultation before releasing such factors. In the subsequent 30 months, 32 adults received 64 courses of treatment. For patients with hemophilia A, the mean cost per admission was reduced by approximately 27% (total savings, $61,536). For patients with factor VIII inhibitor, there was an approximate 6% cost reduction (total savings, $47,292). The combined savings was $108,828. The mean plasma factor level achieved during the intervention period was 84% ± 55% compared with 117% ± 58% for the preintervention period (P = .008). Neither the number of treatment (factor transfusion) days nor the number of RBC transfusions changed significantly. Our data support that pathology consultation yields consistent and appropriate therapy and improves resource utilization. Hemophilia A is a rare and often debilitating bleeding disorder due to deficiency of clotting factor VIII. Fortunately, coagulation factor replacement products exist to provide effective prevention and treatment for hemophilia bleeding complications. Nevertheless, the potential for morbidity and mortality still exists, and treatment is associated with high costs. Factor replacement therapy accounts for nearly 90% of health care costs incurred during hospital stays by patients with hemophilia.1 Any attempt to improve the use of replacement factors must overcome several substantial barriers. First, because patients with hemophilia are hospitalized for various reasons, their attending physicians have backgrounds in many specialties but frequently lack specific training in the management of hemorrhagic diatheses. Moreover, owing to the low prevalence of hemophilia, most physicians treat such patients only sporadically and never become familiar with variations in clinical manifestations and differences in their management with coagulation factor concentrates. Thus, the ability of an institution to provide a unified approach to treating hemophilia could ensure high-quality and cost-effective care. Data on the cost of coagulation replacement therapy are confounded by the use of dissimilar accounting systems and by differences in distribution points, services, and methods.1 Moreover, we are not aware of any study describing the cost of treating patients with coagulation factors in an inpatient setting in the United States. While product use in this setting may represent only a relatively small proportion of the total, it nevertheless can contribute substantially to an institution’s expenses. Thus, analysis of inpatient coagulation product use could have considerable impact by providing insight for better utilization of health care resources in this area. Coagulation and Transfusion Medicine / ORIGINAL ARTICLE Am J Clin Pathol 2003;120:938-943 939 939 DOI: 10.1309/RRE3DB8WRR955WFL 939 © American Society for Clinical Pathology In our institution, the transfusion medicine service stocks and distributes factor concentrates. A review of the transfusion medicine records from August 1998 to July 1999 showed the acquisition cost for factor concentrates was almost $700,000. Consequently, we reviewed laboratory documentation for all patients who were treated with coagulation factor concentrates during the same 12 months, the types and doses of replacement products, and the results of plasma coagulation factor assays performed during treatment. Following the review, the transfusion medicine service enacted new procedures to enable more consistent and efficient use of these expensive products. The objective of this report is 2-fold: (1) to illustrate the impact of a policy that requires clinical pathology consultation before issuing coagulation factors from the transfusion medicine service and (2) to describe the magnitude of 1 institution’s inpatient cost for replacement therapy in hemophilia and other single-factor deficiencies. Materials and Methods The institutional review board of the University of Alabama at Birmingham (UAB) approved this study, which was conducted in 2 parts: retrospective and prospective gathering of data from laboratory records. Retrospective Review We retrieved transfusion service billing records for UAB University Hospital inpatients who had been prescribed coagulation factor concentrates from August 1998 to July 1999. Data analysis included cost linked with patient identity, diagnosis, admitting physician service, reason for treatment, dates of treatment, type and dose of factor concentrate, and results of plasma factor level assays. Coagulation factor purchase costs (not charges to patients) were used for consistency. Acquisition costs were normalized on a per unit basis for the calculations throughout the study and were as follows: plasma-derived factor VIII, $0.35; recombinant factor VIII, $0.68; activated prothrombin complex concentrate, $0.78; porcine factor VIII, $1.29; von Willebrand factor, $0.65; plasma-derived factor IX, $0.55; and prothrombin complex concentrate, $0.40. Intervention and Data Acquisition In August 1999, we instituted a mandatory clinical pathology consultation policy. A resident and attending pathologist reviewed each coagulation factor order and recommended product selection, dosage, and follow-up testing. The steps of the intervention are listed in ❚Table 1❚. Before implementation of this policy, pathology approval was required only if it were the patient’s first treatment in our institution, and there was no standardized approach to the consultation process. Hemophilia Patient Database During the retrospective review, we simultaneously established a database of patients with single-factor deficiencies treated in our institution. Although the most common diagnosis was hemophilia A, congenital or acquired, there also were patients with von Willebrand disease, hemophilia B, and prothrombin deficiency. The database contains patient name and medical record number, age, deficient factor, presence and titer of factor inhibitors, serologic testing results for HIV and hepatitis B or C, date and time of treatment, type and dose of product, and factor level assay results. By consulting database records for returning patients, we were able to make preliminary replacement factor selections without repeating lengthy diagnostic procedures. For example, for patients with known high-titer factor VIII inhibitor, titers were not rechecked every time the patients required treatment. Statistical Analysis We used the Student t test for the comparison of means of factor levels, length of treatment, and number of units of RBCs transfused before and after mandatory clinical pathology consultation.