Mountain State Medical Policy Bulletin |
Section: | Injections |
Number: | I-7 |
Topic: | Erythropoiesis Stimulating Agents (Epoetin alfa [Epogen®, Procrit®], Darbepoetin Alfa [Aranesp®]) |
Effective Date: | October 1, 2008 |
Issued Date: | October 6, 2008 |
Date Last Reviewed: | 09/2008 |
Indications and Limitations of Coverage
Coverage for erythropoiesis stimulating agents is determined according to individual or group customer benefits. DARBEPOETIN ALFA (Aranesp®), EPOETIN ALFA (Epogen®, Procrit®) Erythropoiesis stimulating agents may be considered reasonable and necessary for the treatment of anemia when reversible causes of anemia are identified and managed. Erythropoiesis stimulating agents may be initiated when the hematocrit (HCT) is less than 36% or the hemoglobin (Hgb) is less than 12g/dL, and when the anemia is associated with any of the following conditions:
The use of erythropoiesis stimulating agents for any indication not listed on this policy is considered not medically necessary, and therefore, not covered. A participating preferred, or network provider cannot bill the member for the denied service.
Description Epoetin alfa Darbepoetin alfa |
|
J0881 | J0882 | J0885 | J0886 | Q4081 |
Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition. |
USPDI-Vol. 1, Edition 26, 2006 Micromedex, Inc. Aranesp® (darbepoetin alfa)[package insert]. Thousand Oaks, CA: Amgen, Inc., 2007 Epogen® (epoetin alfa)[package insert]. Thousand Oaks, CA, Amgen, Inc., 2007 Procrit® (epoetin alfa)[package insert]. Thousand Oaks, CA, Amgen, Inc., 2007 NCCN Updates Cancer and Treatment Related Anemia Guidelines. National Comprehensive Cancer Network (NCCN), March 5, 2007 U.S. Food and Drug Administration (FDA). FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs), FDA News, P07-40, Rockville, MD: FDA; March 9, 2007 U.S. Food and Drug Administration (FDA). FDA Public Health Advisory, Epoetin alfa; darbepoetin alfa, Rockville, MD: FDA; November 16, 2006, updated March 9, 2007 U.S. Food and Drug Administration (FDA). FDA Receives New Data on Risks of Anemia Drugs, FDA News, Rockville, MD: January 3, 2008 U.S. Food and Drug Administration (FDA). FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis Stimulating Agents (ESAs), FDA News, Rockville, MD; November 8, 2007 Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease, The New England Journal of Medicine, Vol 355, No. 20, 11/2006 Correction of Anemia-Payoffs and Problems, The New England Journal of Medicine, Vol 355, No. 20, 11/2006 The New FDA Label for Erythropoietin Treatment: How Does it Affect Hemoglobin Target? Kidney Int. 2007; Vol. 72, No. 7 Venous Thromboembolism and Mortality Associated with Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia, JAMA, Vol. 299, No. 8, 02/2008 New Limits Advised for Anemia Drugs, JAMA, Vol. 297, No. 2, 06/2007 Use of Epoetin in Chronic Renal Failure, JAMA, Vol. 297, No. 15, 04/2007 |
[Version 007 of I-7] |
[Version 006 of I-7] |
[Version 005 of I-7] |
[Version 004 of I-7] |
[Version 003 of I-7] |
[Version 002 of I-7] |
[Version 001 of I-7] |