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Arbuckle RB , Griffith NL , Iacovelli LM , Johnson PE , Jorgenson JA , Kloth DD , Lucarelli CD , Muller RJ
Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: Perspectives and issues on policy-guided health care
Pharmacotherapy. 2008 May;28(5) :1S-15S
AbstractErythropoiesis-stimulating agents (ESAs) are approved as an alternative to blood transfusions for treating anemia secondary to chemotherapy in patients with cancer. Recently, ESAs have been a source of controversy and confusion in the oncology community. This began when two European trials-the Breast Cancer Erythropoietin Survival Trial (BEST) and the Advanced Head-and-Neck Cancer Treated with Radiotherapy (ENHANCE) Study-raised safety concerns about decreased overall survival and increased venous thromboembolic events. In 2004, the United States Food and Drug Administration (FDA) convened its Oncologic Drugs Advisory Committee (ODAC) to review the data and reassess the risks and benefits of ESAs in patients with cancer. On May 10, 2007, ODAC reconvened when five trials (BEST, ENHANCE, AMG-20010103, AMG-20000161, and EPO-CAN-20) showed decreased overall survival. The briefing document noted that studies demonstrating detrimental effects on survival and/or tumor outcomes used an unapproved treatment regimen designed to maintain hemoglobin levels above 12 g/dl. On May 14, 2007, just days after the ODAC reconvened, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo for a national coverage determination (NCD) imposing restrictions on ESAs. For health care providers, aspects of the proposed NCD were markedly inconsistent with FDA-approved ESA use and generally were considered ambiguous and unclear. Over objections of several professional associations and members of Congress, on July 30, 2007, CMS posted the final NCD and declared it effective immediately. When compared with FDA-approved labeling and professional society guidelines, the NCD revealed differences in ESA initiation, dosage escalation, dosage reduction, and definition of response. These discrepancies have generated confusion among health care providers, who are struggling over whether they can feasibly provide a dual system of care-one for Medicare patients and another for non-Medicare patients-that is evidence based. With this supplement, we hope to educate health care providers on the issues and challenges associated with policy-guided health care when discrepancies exist between,the policy and evidence-based practice; offer guidance on implementing the NCD; and highlight the important role of pharmacists in the process.
NotesISI Document Delivery No.: 295SM Times Cited: 0 Cited Reference Count: 23 Cited References: *AACR, AACR ANN M 2007 *AM SOC CLIN ONC, STAT FDA LETT *AM SOC CLIN ONC, 2007, CANC POL TOD *AM SOC HEM, 2007, POL PRACT NEWS UPD E *AMG INC, 2007, AR DARB ALF PRESCR I *AMG INC, 2007, EP EP ALF PRESCR INF *AMG INC, 2007, PROCR EP ALF PRESCR *COMM ONC ALL, 2007, ONC CALL MED REC AN *CTR MED MED SERV, ADV BEN NOT *CTR MED MED SERV, PUBL COMM ER STIM AG *DAHANCA, 2006, INT AN DAHANCA 10 ST *FOOD DRUG ADM, ONC DRUGS ADV COMM B *MED LEARN NETW, WHAT DOCT NEED KNOW *NCCN, 2008, NCCN CLIN PRACT GUID, P6 *US DEP HHS, 2005 NAT BLOOD COLL *US ONC PHYS NETW, REQ REC NAT COV DEC GRIFFITH N, 2006, THERAPEUTIC INSIGHTS, P3 HENKE M, 2003, LANCET, V362, P1255 HOUTS AC, 2006, SUPPORT CARE CANCER, V14, P1195 LEYLANDJONES B, 2005, J CLIN ONCOL, V23, P5960 OSSA DF, 2007, PHARMACOECONOMICS, V25, P223 RIZZO JD, 2008, J CLIN ONCOL, V26, P132 SILLIMAN CC, 2006, BLOOD REV, V20, P139 Arbuckle, Rebecca B. Griffith, Niesha L. Iacovelli, Lew M. Johnson, Philip E. Jorgenson, James A. Kloth, Dwight D. Lucarelli, Charles D. Muller, Raymond J. PHARMACOTHERAPY PUBLICATIONS INC; NEW ENGLAND MEDICAL CENTER, 806, 750 WASHINGTON ST, BOSTON, MA 02111 USA Part 2 Suppl. S