Cost-effectiveness of FDA variance for blood collection from individuals with hereditary hemochromatosis at a 398-bed hospital-based donor center

Hereditary hemochromatosis (HH) is treated by therapeutic phlebotomy to reduce excess body iron. This 398-bed, hospital-based donor center wanted to determine whether there was a financial advantage to requesting FDA approval to allow transfusion of blood components from eligible individuals with HH. Donor center records from 2008 were reviewed to identify all therapeutic phlebotomy patients with a diagnosis of HH. HH patients were contacted and asked to complete the AABB Uniform Donor History Questionnaire (UDHQ) to determine their eligibility as potential allogeneic blood donors. Financial ramifications attributable to loss of revenue from the therapeutic phlebotomies ($100/collection) were compared with the potential gain in revenue from collecting units for transfusion ($429/collection) in a 12-month period. Nineteen HH patients were identified and screened for allogeneic eligibility. Seventeen patients (89%) met the eligibility criteria for allogeneic donors, and two patients (11%) did not. Retrospective review of donor records indicated that a total of 60 units were collected from these HH patients from January 2008 through December 2008. Fifty-five of the 60 units collected (92%) were eligible for allogeneic use, potentially generating gross revenue of $23,595. After deducting expenses for infectious disease testing and loss of revenue for the non-qualified therapeutic phlebotomies, the net revenue from the collection of 55 RBC units that could have potentially been used for allogeneic transfusion was $20,345. In contrast, the current revenue generated by the collection of 60 therapeutic phlebotomies was only $6,000. In 2008, using eligible HH individuals as allogeneic blood donors would have resulted in an increase in revenue of $14,345 for our blood center. This study demonstrates that even at a medium-size, hospital-based donor center, obtaining a variance from the FDA to establish an HH blood donor program is a cost-effective endeavor, which does not compromise donor or patient safety.