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.

 Pre-NCD (n=800) Post-NCD (n=994) p value 
 Patient Characteristics 
Age, years (mean) 71.3 70.6 0.1032 
Female Gender 68% 65% 0.2061 
Tumor Type   0.9600 
    Breast 30% 29%  
    Lung 41% 42%  
    Colorectal 30% 29%  
    
 Chemotherapy Exposure During Follow-up 
Anthracyclines 15% 12% 0.0180 
Taxane 31% 40% 0.0002 
Platinum 49% 53% 0.0451 
Biologic 18% 22% 0.0314 
Antimetabolite 44% 39% 0.0193 
Plant alkaloids and/or topoisomerase II inhibitor 20% 18% 0.2415 
    
 Hematologic Outcomes - Mean Hb (g/dL) 
Baseline 10.4 (n=791) 10.3 (n=987) 0.0003 
4 weeks 10.9 (n=588) 10.6 (n=676) <0.0001 
8 weeks 11.1 (n=520) 10.7 (n=632) <0.0001 
12 weeks 11.3 (n=379) 10.9 (n=453) <0.0001 
 ESA utilization 
Proportion with ESA treatment 88% 56% <0.0001 
ESA Treatment Duration, days (mean) 48 32 <0.0001 
 Unadjusted Transfusion Outcomes 
Proportion Receiving Transfusion 15.3% 19.1% 0.0382 
Units transfused per patient (mean) 0.36 0.55 0.0014 
 Pre-NCD (n=800) Post-NCD (n=994) p value 
 Patient Characteristics 
Age, years (mean) 71.3 70.6 0.1032 
Female Gender 68% 65% 0.2061 
Tumor Type   0.9600 
    Breast 30% 29%  
    Lung 41% 42%  
    Colorectal 30% 29%  
    
 Chemotherapy Exposure During Follow-up 
Anthracyclines 15% 12% 0.0180 
Taxane 31% 40% 0.0002 
Platinum 49% 53% 0.0451 
Biologic 18% 22% 0.0314 
Antimetabolite 44% 39% 0.0193 
Plant alkaloids and/or topoisomerase II inhibitor 20% 18% 0.2415 
    
 Hematologic Outcomes - Mean Hb (g/dL) 
Baseline 10.4 (n=791) 10.3 (n=987) 0.0003 
4 weeks 10.9 (n=588) 10.6 (n=676) <0.0001 
8 weeks 11.1 (n=520) 10.7 (n=632) <0.0001 
12 weeks 11.3 (n=379) 10.9 (n=453) <0.0001 
 ESA utilization 
Proportion with ESA treatment 88% 56% <0.0001 
ESA Treatment Duration, days (mean) 48 32 <0.0001 
 Unadjusted Transfusion Outcomes 
Proportion Receiving Transfusion 15.3% 19.1% 0.0382 
Units transfused per patient (mean) 0.36 0.55 0.0014 
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.

Author notes

*

Asterisk with author names denotes non-ASH members.