Pre- and Post-National Coverage Determination (NCD) Hematologic Outcomes and Blood Utilization in Cancer Patients with Chemotherapy-Induced Anemia (CIA): Results From a Multicenter Chart Review.
Authors: Henry David H. , Langer Corey J. , McKenzie R. Scott , Piech Catherine Tak , Senbetta Mekré , Schulman Kathy L. , Stepanski Edward J. 
Published: October 2019

Abstract
Abstract 2491
Poster Board II-468

Introduction:
In July 2007, the Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA through an NCD, which limits ESA utilization in patients with CIA to hemoglobin (Hb) levels of less than 10 g/dL at ESA initiation and after the initial 4 weeks of treatment. The primary objective of this study was to compare transfusion rates in patients with breast, colorectal or lung cancer who developed CIA before and after the NCD, regardless of treatment with ESAs.

Patients and Methods:
Chart data from adult cancer patients with Medicare as their primary payer and treated at community oncology clinics were abstracted for 12 weeks following the beginning of a CIA episode, provided that the entire episode occurred either before or after the change in policy. CIA was defined as Hb level < 11 g/dL, while receiving chemotherapy or within 8 weeks (60 days) of the last dose of chemotherapy. Logistic regression was used to calculate the odds of transfusion following the Hb < 11 g/dL index date. A negative binomial model was used to assess the change in units of blood transfused per patient. Multivariate models controlled for differences in age, gender, cancer type, line of therapy, ECOG performance status, history of antecedent transfusion and exposure to platinum, anthracyclines, antimetabolites and plant alkaloids.

Results:
1794 patients were identified (800 Pre-NCD and 994 Post-NCD) from 49 sites. Patient groups were similar with respect to age, gender, race, weight, tumor type, line of treatment and recent exposure to radiation or surgery. As shown in the table below, there were significant differences in the chemotherapy class exposure in the Post- vs. Pre-NCD period. In addition, Hb levels were lower in the Post-NCD period, with a decrease in the proportion of ESA-treated patients and ESA treatment duration. The odds of receiving a transfusion were significantly higher Post-NCD (OR 1.41, 95% CI; 1.05 - 1.89; p=0.02) with an overall increase in adjusted units transfused of 53% (OR 1.53, 95% CI; 1.15 - 2.04; p=0.003). The table below summarizes patient characteristics and unadjusted Hb and transfusion outcomes.

Conclusion:
This large multicenter chart review reported decreased frequency and duration of ESA administration in CIA patients with Hb < 11 g/dL in the Post-NCD period compared to the Pre-NCD period. This was accompanied by a modest but statistically significant increase in blood utilization and decrease in Hb values. Further studies are warranted to assess other outcomes.

Disclosures:
McKenzie: Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Schulman:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Stepanski:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.