Effect of New Institutional Algorithm for Chemotherapy Induced Anemia (CIA) on Erythropoiesis-Stimulating Agent Treatment Patterns and Costs in Lymphoma Patients

Abstract

Recently there has been accumulating data regarding the increased risks of mortality, thrombosis, cardiovascular events, and of possible tumor promotion when administering erythropoiesis-stimulating agents (ESAs) to a target hemoglobin (Hgb) level of 12 g/dL. In response to this evidence, the FDA mandated a Black Box warning and the CMS mandated changes in coverage for ESAs. Subsequently, in December, 2007, the University of Texas M.D. Anderson Cancer Center (M. D. Anderson) developed and implemented an institutional practice algorithm to advise physicians regarding treatment of CIA, which included recommendations for the initiation and continued use of ESAs. The objective of this study was to assess the impact of the new institutional practice algorithm on the treatment patterns and costs of CIA in lymphoma patients. The study design was a retrospective study with a historical control group. The historical controls (pre-group) consisted of lymphoma patients diagnosed with CIA between January 1, 2007–April 30, 2007 and the cases (post-group) consisted of lymphoma patients diagnosed with CIA between January 1, 2008–April 30, 2008, who were all followed for a period of up to 16 weeks. Patient demographics, chemotherapy type, ESA type and dosage, transfusions received, Hgb values at the time of ESA usage and transfusions (for all doses and transfusions received at the institution during the study period), and costs for ESA treatment and transfusions were extracted from patient medical charts and institutional databases at M. D. Anderson. Descriptive statistics, t-tests, Mann- Whitney U, and chi-square analyses were conducted to evaluate the study objectives. The study population consisted of 154 patients; 90 patients in the pre-group and 64 patients in the post-group. Both groups had similar demographic and baseline clinical characteristics. In the post period, though there was a significant decrease in the overall amount of ESA units dispensed per patient (p=0.0125), there was an increase in the amount of ESA units dispensed in the first eight weeks of treatment (p=0.03), indicating potentially less use of outside pharmacies. There was a significant decrease in the mean Hgb at the time of ESA usage, from 9.59g/dL to 8.98g/dL (p<0.0001). The proportion of patients who received an ESA at a Hgb level > 10 g/dL decreased significantly, from 66% to 17% (p<0.0001). There was no significant difference in the mean Hgb level at week 4 of therapy, which may indicate that patients were not clinically affected by the change in practice. There was also no significant difference in the number of transfusions administered, or the costs associated with the treatment of CIA in the study population. The results indicate that the new institutional algorithm was effective in altering the treatment patterns of CIA with respect to the ESA units prescribed and dispensed and the hemoglobin levels at the time of ESA usage in lymphoma patients.