BlueCross BlueShield of Tennessee Medical Policy Manual

Pegfilgrastim

NDC CODE(S)

55513-0190-XX - Neulasta 6 MG/0.6ML SOSY (AMGEN)

 

55513-0192-XX - Neulasta Onpro 6 MG/0.6ML PSKT (AMGEN)

DESCRIPTION

Pegfilgrastim is a recombinant granulocyte colony stimulating factor (rG-CSF).  Colony stimulating factors (CSFs) are naturally occurring cytokine glycoproteins classified as immunomodulators. They serve as growth factors specifically for myeloid hematopoietic cells.  A granulocyte colony stimulating factor (G-CSF) specifically modulates neutrophils and their precursors, regulating their production within the bone marrow and affecting neutrophil progenitor proliferation, differentiation and selected end-cell functional activation.

Pegfilgrastim is the pegylated form of filgrastim in which molecules are covalently linked to methoxypolyethylene glycol through the process of pegylation.  This stabilizes the filgrastim molecules and protects them from enzymatic and phagocytic degradation allowing them to remain active within the body for a longer period of time.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

** expected incidence of febrile neutropenia percentages for myelosuppressive chemotherapy regimens can be found in the NCCN Myeloid Growth Factors Clinical Practice Guideline at NCCN.org.

 

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Acute Radiation Exposure

6 mg subcutaneously weekly x 2 doses (Use weight based dosing for pediatrics weighing <45 kg)
Neulasta* – all other indications

<10 kg = 0.1 mg/kg

10-20 kg = 1.5 mg

21-30 kg = 2.5 mg

31-44 kg = 4 mg

45 kg and up = 6 mg

Dosed no more frequently than every 14 days

*Do not administer within 14 days before or 24 hours after administration of a cytotoxic chemotherapy.  

*Onpro On-body Injector may be administered on the same day as chemotherapy as long as the Neulasta is administered no less than 24 hours after administration of chemotherapy. Not recommended for use in patients with acute radiation exposure

LENGTH OF AUTHORIZATION

Coverage is provided for four 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. (2018). AHFS DI. Pegfilgrastim. Retrieved October 24, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (September, 2018). Pegfilgrastim. Retrieved October  24, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Pegfilgrastim.

Retrieved October 24, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018.June). Center for Drug Evaluation and Research. Neulasta® Pegfilgrastim. Retrieved October 24, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125031s189s191lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  3/2/2019

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 = 6 mg

DIAGNOSIS

MAXIMUM UNITS

Acute Radiation Exposure

1 billable unit weekly x 2 doses

All  other indications

1 billable unit per 14 days