Abstract

Background: In July 2007, the Centers for Medicare and Medicaid Services issued ESA coverage limitations for cancer patients with CIA through a national coverage determination (NCD). Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic outcomes in the Medicare population treated in pre- and post-NCD time period, an analysis of hematologic outcomes from the DOSE (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted.

Methods: ESA-treated cancer patients with CIA were selected based on Medicare primary coverage, available baseline hemoglobin (Hb) value, and receipt of at least two ESA administrations. Data were categorized into two timeframes based on date of initial ESA administration: pre-NCD (4/06-4/07) and post-NCD (10/07-5/08). Baseline demographics, Hb values during ESA treatment, and blood utilization patterns were analyzed.

Results: 288 patients were identified (Pre-NCD – 230; Post-NCD – 58) from 41 sites. Patient groups were similar with respect to age, gender, weight, and tumor type. ESA treatment duration was significantly greater in the pre-NCD group (70 days vs. 54 days, p = 0.0011). As shown in the table, differences with regard to blood utilization and Hb values were observed between the Pre-NCD and Post-NCD populations. A significantly greater proportion of patients required a blood transfusion and the number of units administered per study patient was significantly higher in the Post-NCD group. Hb levels were significantly lower at all time points of observation in the Post-NCD group.

Pre-NCDPost-NCDp-value
Transfusion Outcomes 
Proportion of Patients Transfused 18.3% 32.8% p = 0.0157 
Mean No. of Units per Study Patient 0.5 1.1 p = 0.0089 
Hematologic Outcomes: Mean Hb (SD) 
Baseline 10.6 (0.8) 9.6 (0.5) < 0.0001 
Week 4 11.1 (1.3) 9.9 (1.1) < 0.0001 
Week 8 11.2 (1.3) 10.4 (1.3) 0.013 
Week 12 11.1 (1.3) 9.8 (1.2) 0.0002 
Week 16 11.0 (1.1) 9.7 (0.2) 0.018 
Pre-NCDPost-NCDp-value
Transfusion Outcomes 
Proportion of Patients Transfused 18.3% 32.8% p = 0.0157 
Mean No. of Units per Study Patient 0.5 1.1 p = 0.0089 
Hematologic Outcomes: Mean Hb (SD) 
Baseline 10.6 (0.8) 9.6 (0.5) < 0.0001 
Week 4 11.1 (1.3) 9.9 (1.1) < 0.0001 
Week 8 11.2 (1.3) 10.4 (1.3) 0.013 
Week 12 11.1 (1.3) 9.8 (1.2) 0.0002 
Week 16 11.0 (1.1) 9.7 (0.2) 0.018 

Conclusion: Greater blood utilization and lower Hb values were observed in Medicare CIA patients treated with ESAs during the Post-NCD time period compared to the Pre- NCD time period. The impact of the NCD on patient outcomes is important to providers and hospital systems and warrants further research.

Disclosures: Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Apgar:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Bookhart:Centocor Ortho Biotech Services, LLC: Employment. Corral:Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.

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