Hematologic and Hospitalization Outcomes in Patients with Chemotherapy-Induced Anemia (CIA) Treated with Erythropoiesis-Stimulating Agents (ESAs) in the Pre- Vs Post-National Coverage Determination (NCD) Time Periods.

National coverage limitations for ESA treatment in cancer patients with CIA were established by the Centers for Medicare & Medicaid Services in July 2007. Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic and hospitalization outcomes in CIA patients treated in Pre- and Post-NCD time periods, an analysis of data from the D.O.S.E. (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted.

ESA-treated cancer patients with CIA were selected if they initiated ESA treatment 12/01/2005-04/01/2007 (Pre-NCD) or 10/01/2007-02/01/2009 (Post-NCD), had ≥ 2 ESA administrations, and had both a baseline and ≥ 1 transfusion-independent post-ESA initiation hemoglobin (Hb) assessment. Assessed outcomes included proportion of patients receiving blood transfusion, number of units/study patient, Hb levels (at baseline and at weeks 4, 8, 12, 16) and hospitalization rates (admissions, number of hospital days) adjusted for ESA therapeutic duration (defined as time (days) from first to last ESA administration + patient-specific ESA treatment interval).

This analysis included 836 patients (Pre-NCD 585; Post-NCD 251) from 54 sites. Patients in the Pre-NCD and Post-NCD cohorts were similar in gender distribution and weight. The Post-NCD cohort was significantly older (64.7 yrs vs. 61.9 yrs; p<0.01). The groups also differed significantly in overall tumor type distribution (p<0.0001). The Post-NCD group had a lower proportion of patients with breast cancer and higher proportion of patients with lung cancer and gynecologic malignancies. ESA treatment duration was significantly shorter in the Post-NCD group (mean days ± SD: Post-NCD 55.5 ± 32.7, Pre-NCD 65.8 ± 33.8, p<0.0001). The proportion of patients receiving blood transfusion was significantly greater in the Post-NCD group (Post-NCD 26.7%, Pre-NCD 15.6%, p=0.0002) as was blood utilization (Units/study patient: Post-NCD 0.9, Pre-NCD 0.4, p=0.0001). As shown in the table, Hb levels were significantly lower at all time points in the Post-NCD group.

The rate of hospital admissions was significantly greater in the Post-NCD group [Admissions/100-patient ESA therapeutic days (95% CI): Post-NCD 0.42 (0.34, 0.53), Pre-NCD 0.28 (0.24, 0.33)] as was the number of hospital days [Hospital days/100-patient ESA therapeutic days (95% CI): Post-NCD 2.3 (2.1, 2.5), Pre-NCD 1.3 (1.2, 1.4)].

Significantly greater blood utilization and lower Hb levels were observed in ESA-treated CIA patients in the Post-NCD period compared to the Pre-NCD period. Rates of hospitalizations and hospital length of stay were also significantly greater in the Post-NCD group. Study of comparative hematologic and resource utilization outcomes before and after the NCD is warranted in additional clinical centers.

Apgar:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Ellis:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.