BlueCross BlueShield of Tennessee Medical Policy Manual

Epoetin Alfa-epbx for non-ESRD (non-dialysis)

NDC CODE(S)

00069-1305-XX Retacrit 2000 UNIT/ML SOLN (PFIZER U.S.)

00069-1306-XX Retacrit 3000 UNIT/ML SOLN (PFIZER U.S.)

00069-1307-XX Retacrit 4000 UNIT/ML SOLN (PFIZER U.S.)

00069-1308-XX Retacrit 10000 UNIT/ML SOLN (PFIZER U.S.)

00069-1309-XX Retacrit 40000 UNIT/ML SOLN (PFIZER U.S.)

59353-0002-XX Retacrit 2000 UNIT/ML SOLN (VIFOR)

59353-0003-XX Retacrit 3000 UNIT/ML SOLN (VIFOR)

59353-0004-XX Retacrit 4000 UNIT/ML SOLN (VIFOR)

59353-0010-XX Retacrit 10000 UNIT/ML SOLN (VIFOR) 

00069-1305-XX Retacrit 2000 UNIT/ML SOLN (PFIZER U.S.)

DESCRIPTION

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

Epoetin alfa-epbx is a biosimilar to Epogen/Procrit (epoetin alfa) an erythropoiesis-stimulating agent (ESA). Epoetin alfa-epbx is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. The product contains 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 – non-dialysis **

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

  • Pediatric patients (1 month or older): 50 units/kg intravenously or subcutaneously three times weekly

Anemia due to HIV on zidovudine

  • 100 units/kg three times weekly

  • May titrate up to 300 units/kg

Anemia due to chemotherapy**

  • Adults: 150 units/kg intravenously or subcutaneously three times weekly or 40,000 units once weekly

    • May titrate up to 300 units/kg three times weekly or 60,000 units once weekly

  • Pediatric patients (5-18 years): 600 units/kg intravenously or subcutaneously once weekly

    • May titrate up to 900 units/kg once weekly

Perioperative use

  • 300 units/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery (15 days total)

  • 600 units/kg/dose subcutaneously on days 21, 14, and 7 before surgery plus 1 dose on the day of surgery (4 total doses)

Anemia due to MDS/MPN

  • 150-300 units/kg intravenously or subcutaneously three times weekly

  • 40,000 to 60,000 units once to twice weekly

All other indications

Dosing varies; generally up to 150 units/kg intravenously or subcutaneously three times weekly

Most commonly initiated dose

40,000 units weekly

**

  • 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.

  • For patients with CKD,

  • 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.

  • For patients on Cancer Chemotherapy

  • After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue therapy

  • For zidovudine treated HIV infected patients

  • If the patient fails to respond after 8 weeks of therapy, increase dose by approximately 50-100 U/kg at 4- to 8- week until the hemoglobin reaches levels need to avoid transfusion or max dosing reached.

  • If the hemoglobin exceeds the indication specific level noted above, withhold therapy and resume therapy once level declines to <11 g/dL, at a dose 25% below the previous dose.

LENGTH OF AUTHORIZATION

Coverage will be provided for 45 days 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

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

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium™. Epoetin alfa-epbx. Retrieved April 17, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2019 January). Center for Drug Evaluation and Research. Epoetin alfa-epbx injection, for intravenous or subcutaneous use . Retrieved April 22, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s000lbl.pdf.

ORIGINAL EFFECTIVE DATE: 10/1/2018

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

DIAGNOSIS

MAXIMUM UNITS

MDS and MPN:

120,000 units every 7 days

Surgery patients:

600,000 units every 15 days

All other indications:

60,000 units every 7 days