Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: Perspectives and issues on policy-guided health care Journal Article
| Authors: | Arbuckle, R. B.; Griffith, N. L.; Iacovelli, L. M.; Johnson, P. E.; Jorgenson, J. A.; Kloth, D. D.; Lucarelli, C. D.; Muller, R. J. |
| Article Title: | Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: Perspectives and issues on policy-guided health care |
| Abstract: | Erythropoiesis-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. |
| Keywords: | cancer chemotherapy; cancer survival; overall survival; clinical trial; review; drug dose reduction; drug safety; risk benefit analysis; antineoplastic agents; united states; united states food and drug administration; antineoplastic agent; evidence based medicine; evidence-based medicine; neoplasms; breast cancer; erythropoietin; anemia; practice guideline; health care policy; medicare; health policy; blood disease; head and neck cancer; practice guidelines as topic; blood transfusion; drug dose increase; blood clotting disorder; guidelines; recombinant erythropoietin; vascular disease; venous thromboembolism; novel erythropoiesis stimulating protein; hematinics; pharmacists; centers for medicare and medicaid services; cms; darbepoetin alfa; epoetin alfa; erythropoiesis- stimulating agents; esas; national coverage determination; ncd; pharmacists' role; hemoglobin determination; controlled clinical trials as topic |
| Journal Title: | Pharmacotherapy |
| Volume: | 28 |
| Issue: | 5 Part 2 |
| ISSN: | 0277-0008 |
| Publisher: | John Wiley & Sons |
| Date Published: | 2008-05-01 |
| Start Page: | 1S |
| End Page: | 15S |
| Language: | English |
| PUBMED: | 18447704 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 6" - "Export Date: 17 November 2011" - "CODEN: PHPYD" - "Source: Scopus" |
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