Costs of care for lung and colon cancer patients receiving chemotherapy following FDA policy changes.

PURPOSE: Use of erythropoiesis-stimulating agents (ESAs) in US cancer care declined amidst post-marketing evidence of adverse effects and the Food and Drug Administration's (FDA) addition of a "black-box" warning to product labeling in March 2007. Because reduced ESA use may have led to more transfusions or increased anemia-related health care needs, we measured the policy's impact on health care costs of lung and colon cancer patients receiving chemotherapy. METHODS: In a retrospective cohort study of 13,630 lung and 3,198 colon cancer patients in the Department of Veterans Affairs (VA) between 2002 and 2008, we calculated anemia treatment (ESA and transfusion), cancer- and non-cancer-related, and total health care costs for the chemotherapy episode of care. We used multivariable regression to examine health care costs and utilization between patients whose chemotherapy was administered before (PRE) or after (POST) March 1, 2007. RESULTS: ESA costs declined and transfusion costs were similar, resulting in lower overall POST-period anemia treatment costs (lung, $526 lower, P < 0.01; colon, $504 lower, P < 0.01). Other cancer-related health care costs increased, resulting in markedly higher POST-period total health care costs (lung, $4,706 higher, P < 0.01; colon, $11,414 higher, P < 0.01). CONCLUSIONS: Although chemotherapy episode anemia treatment costs declined after the black-box warning, the savings were offset by increases in other cancer-related costs. Those increases were mainly in outpatient services and pharmacy, suggesting that likely drivers include adoption of new high-cost diagnostic approaches and therapeutic modalities. Additional research is needed to determine the effects of anemia management changes on patient outcomes and to more fully understand cost-benefit relationships in cancer treatment.

Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes.

STUDY OBJECTIVE: To determine whether the hemoglobin level at which health care providers prescribed erythropoiesis-stimulating agent (ESA) therapy (trigger hemoglobin level) for their patients receiving chemotherapy was lower after the United States Food and Drug Administration (FDA) mandated a black-box warning in March 2007. DESIGN: Retrospective analysis. DATA SOURCE: U.S. Department of Veterans Affairs Healthcare System (VA) national databases. PATIENTS: A total of 7450 patients who were diagnosed with cancer between 2002 and 2009, were undergoing chemotherapy, and who received an ESA within 12 months after their cancer diagnosis. MEASUREMENTS AND MAIN RESULTS: Data were collected on patients' demographic, clinical, environmental, and treatment-related factors. After controlling for these factors, multivariable regression analyses were used to compare the trigger hemoglobin level before and after the FDA-mandated labeling change. The average trigger hemoglobin level was 0.73 g/dl lower after the labeling change (95% confidence interval [CI] -0.84 to -0.63). Moreover, the decline in trigger hemoglobin levels began in mid-2006, when the average trigger hemoglobin level fell from 10.50 g/dl in early 2006 (95% CI 10.36-10.63) to 9.30 g/dl by late 2009 (95% CI 9.10-9.49). CONCLUSION: Even before the 2007 FDA-mandated changes in ESA product labeling, hemoglobin levels that triggered ESA treatment began declining for patients receiving cancer care within the VA. This highlights the critical importance of dissemination of postmarketing safety data to impact shifts in ESA use for anemia management.

Trends in anemia management in lung and colon cancer patients in the US Department of Veterans Affairs, 2002-2008.

PURPOSE: In 2007, growing concerns about adverse impacts of erythropoiesis-stimulating agents (ESAs) in cancer patients led to an FDA-mandated black box warning on product labeling, publication of revised clinical guidelines, and a Medicare coverage decision limiting ESA coverage. We examined ESA therapy in lung and colon cancer patients receiving chemotherapy in the VA from 2002 to 2008 to ascertain trends in and predictors of ESA use. METHODS: A retrospective study employed national VA databases to "observe" treatment for a 12-month period following diagnosis. Multivariable logistic regression analyses evaluated changes in ESA use following the FDA-mandated black box warning in March 2007 and examined trends in ESA administration between 2002 and 2008. RESULTS: Among 17,014 lung and 4,225 colon cancer patients, those treated after the March 2007 FDA decision had 65% (lung OR 0.35, CI(95%) 0.30-0.42) and 53% (colon OR 0.47, CI(95%) 0.36-0.63) reduced odds of ESA treatment compared to those treated before. Declines in predicted probabilities of ESA use began in 2006. The magnitude of the declines differed across age groups among colon patients (p = 0.01) and levels of hemoglobin among lung cancer patients (p = 0.04). CONCLUSIONS: Use of ESA treatment for anemia in VA cancer care declined markedly after 2005, well before the 2007 changes in product labeling and clinical guidelines. This suggests that earlier dissemination of research results had marked impacts on practice patterns with these agents.