BlueCross BlueShield of Tennessee Medical Policy Manual

Epoetin Alfa for ESRD (dialysis)

 

NDC CODE(S)

55513-0126-XX Epogen 2000 UNIT/ML SOLN (AMGEN)

55513-0144-XX Epogen 10000 UNIT/ML SOLN (AMGEN)

55513-0148-XX Epogen 4000 UNIT/ML SOLN (AMGEN)

55513-0267-XX Epogen 3000 UNIT/ML SOLN (AMGEN)

55513-0283-XX Epogen 10000 UNIT/ML SOLN (AMGEN)

55513-0478-XX Epogen 20000 UNIT/ML SOLN (AMGEN)

59676-0302-XX Procrit 2000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0303-XX Procrit 3000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0304-XX Procrit 4000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0310-XX Procrit 10000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0312-XX Procrit 10000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0320-XX Procrit 20000 UNIT/ML SOLN (JANSSEN PRODUCTS)

59676-0340-XX Procrit 40000 UNIT/ML SOLN (JANSSEN PRODUCTS)

DESCRIPTION

Erythropoietin is a glycoprotein produced in the kidneys responsible for the stimulation of red blood cell production.

Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology.  It is manufactured in the identical amino acid sequence of isolated natural erythropoietin. Like the endogenous hormone, it stimulates increased production of red blood cells in individuals with functioning erythropoiesis and is referred to as an erythropoietin-stimulating agent or an ESA.  

POLICY 

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Anemia due to CKD-dialysis**

·         Adults: 50-100 units/kg intravenously or subcutaneously three times weekly

·         Pediatric patients: 50 units/kg intravenously or subcutaneously three times weekly

Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis

Aranesp is administered less frequently than epoetin alfa

·         Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly.

·         Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly.

Maintain the route of administration (intravenous or subcutaneous injection).

**

·         Dose increases of 25% can be considered if after 4 weeks of initial therapy the hemoglobin has increased less than 1 g/dL and the current hemoglobin level is less than the indication specific level noted above

·         Dose decreases of 25% or more can be considered if the hemoglobin rises rapidly by more than 1 g/dL in any 2-week period

·         Dose and frequency requested are the minimum necessary for the patient to avoid RBC transfusions.

·         Avoid frequent dose adjustments. Do not increase the dose more frequently than once every 4 weeks; decreases can occur more frequently.

·         If patients fail to respond over a 12-week dose escalation period, further doses increases are unlikely to improve response and discontinuation of therapy should be considered.   

LENGTH OF AUTHORIZATION

ESRD: Coverage will be provided for 12 months and may be renewed.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexi-Comp Online. (2019). AHFS DI. Epoetin alfa. Retrieved April 17, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). Epoetin alfa. Retrieved April 17, 2019 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2018, July) Center for Drug  Evaluation and Research. Label and Approval History. Epogen® (epoetin alfa) injection. Reference ID: 4160848.  Retrieved April 17, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103234s5363s5366lbl.pdf.

ORIGINAL EFFECTIVE DATE: 1/14/2006

MOST RECENT REVIEW DATE:  8/30/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

1 billable unit = 100 Units

DIAGNOSIS

MAXIMUM UNITS

Anemia due to CKD - Dialysis

400 billable units every 7 days