BlueCross BlueShield of Tennessee Medical Policy Manual

Methoxy Polyethylene Glycol-Epoetin Beta

NDC CODE(S)

00004-0401 & 59353-0401 - Mircera 50mcg/0.3ml Inj. (Vifor Inc)

 

00004-0402 & 59353-0402 - Mircera 75mcg/0.3ml Inj. (Vifor Inc)

 

00004-0403 & 59353-0403 - Mircera 100mcg/0.3ml Inj. (Vifor Inc)

 

00004-0405 & 59353-0405 - Mircera 200mcg/0.3ml Inj. (Vifor Inc)

DESCRIPTION

Endogenous erythropoietin is a primary growth factor for the development of red blood cells produced in the kidney and released into the bloodstream in response to hypoxia, increasing production in response to greater need for oxygenation. Individuals with chronic kidney disease have impaired production of erythropoietin.  This erythropoietin deficiency is the primary cause of their anemia.

In response to a more efficient long-term provision of erythropoietin to individuals with chronic kidney disease, methoxy polyethylene glycol-epoetin beta was developed.  It is an erythropoietin stimulating agent which differs from endogenous erythropoietin through the formation of a chemical bond with methoxy polyethylene glycol (PEG).  It has greater activity in the body as well as increased half-life as compared to erythropoietin.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

CKD

120mcg-360mcg every 4 weeks;  Most common starting dose: 0.6 mcg/kg once every 2 weeks

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).

No controlled studies were found in the published literature that validate the use of methoxy polyethylene glycol-epoetin beta for the treatment of any other conditions or diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Methoxy polyethylene glycol-epoetin beta. Retrieved November 9, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, April). Center for Drug Evaluation and Research. Mircera® (methoxy polyethylene glycol-epoetin beta) solution for injection: intravenous [IV] or subcutaneous [SC] use. Retrieved November 9, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:  2/27/2018

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.

Pharmaceutical Decision Support Tree

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Does the individual have a diagnosis of chronic kidney disease (CKD), on dialysis or not?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 360 billable units every 28 days for dosage of 120mcg-360mcg every 4 weeks with an authorization period of 12 months for an individual on dialysis and 45 days for an individual who is not on dialysis with renewal eligibility?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual meet ALL of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria for renewal as per #4 criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.