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T 15: Impact of Risk Evaluation Mitigation Strategy on Use of Erythropoiesis-Stimulating Agents





Poster Presenter

      Kristen Hollingsworth

      • Global Business Leader, Diagnostics-Oncology
      • Johnson & Johnson
        United States

Objectives

To determine if a significant difference exists in the proportion of Medicare patients with breast and lung cancers with CIA treated with erythropoiesis-stimulating agents (ESAs) pre and post-REMS.

Method

Retrospective observational study utilizing Medicare 5% sample data in patients with breast and lung cancers. Observational Periods: Pre-REMS: 1Q2008 – 4Q2009; Post-REMS: 1Q2010 – 4Q2011

Results

ESA use decreased sharply in breast and lung cancer patients and reached statistical significance in both (p < 0.0001); patient categories were not impacted differently Breast Patient Group-Pre-REMS: Sample Size: 493, ESA: 387,Use 78.5%; Post-REMS: Sample Size: 562, ESA: 295, Use 52.5%; Unadjusted OR: 0.30; 95% CI: [0.23;0.40]; p: <.0001; Adjusted OR: 0.32; 95% CI: [0.23, 0.40]; p: <.0001 Lung Patient Group-Pre-REMS: Sample Size: 1,083, ESA: 904,Use 83.5%; Post-REMS: Sample Size: 1,198, ESA: 698, Use 58.3%; Unadjusted OR: 0.28; 95% CI: [0.23;0.34]; p: <.0001; Adjusted OR: 0.27; 95% CI: [0.22, 0.33]; p: <.0001

Conclusion

ESA use decreased in breast and lung cancer patients and reached statistical significance in both; patient categories were not impacted differently. Decrease in ESA use post-REMS implementation was found for patients with both breast and lung cancers and was statistically significant. Patient categories were not impacted differently. These results confirm previous research of an impact of safety warnings on the use of ESAs. (Previous research focused on implications of the National Coverage Determination and black box warning on the use of ESAs.)