Erythropoiesis-stimulating agent use after changes in medicare reimbursement policies

Purpose: Since 2004, concerns about the safety of erythropoiesis-stimulating agents (ESAs) have resulted in label changes and restrictions on their use. We examined changes in ESA use and blood transfusions over time. Methods: The SEER-Medicare database was used to identify patients age ≥ 65 years with breast, lung, prostate, ovary, or colon cancer, diagnosed between 2000 and 2007, who had a chemotherapy claim after their cancer diagnosis. We calculated the mean number of ESA claims per patient per year. Follow-up claims were available through 2008. We used multivariable logistic regression models to analyze the association of ESA use and extended ESA use with clinical and demographic variables. Results: Among 121,169 patients identified, 46,063 (38%) received an ESA. ESA use increased from 12.4% to 16.2% by 2006 and then decreased to 7.9% by 2008. Similarly, the mean number of ESA claims per patient decreased steadily over the entire timeframe. The annual percentage of patients undergoing transfusion remained relatively constant (9% to 10%). In a Cox proportional hazards time-dependent model, ESA use was positively associated with black race (odds ratio [OR], 1.11; 95% CI, 1.07 to 1.15), metropolitan location (OR, 1.17; 95% CI, 1.13 to 1.21), metastatic disease (OR, 1.39; 95% CI, 1.35 to 1.41), female sex (OR, 1.17; 95% CI, 1.14 to 1.20), > one comorbidity (OR, 1.29; 95% CI, 1.25 to 1.32), and tumor type. The number of denied claims increased over time. Conclusion: Our study demonstrated a rapid decline in the percentage of patients treated with ESAs after changes to reimbursement policy, but not after warnings about use. Reimbursement restrictions of other overused or off-label drugs may help reduce health care expenditures.