BlueCross BlueShield of Tennessee Medical Policy Manual

Pegfilgrastim-jmdb

NDC CODE(S)

67457-0833-XX  Fulphila 6 MG/0.6 ML SOSY  (MYLAN INSTITUTIONAL)

DESCRIPTION

Pegfilgrastim-jmdb, a biosimilar of pegfilgrastim; is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol.  Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene.  To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF.

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

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

<10kg = 0.1mg/kg

10-20kg = 1.5mg

21-30kg = 2.5mg

31-44kg = 4mg

45kg and up = 6mg

Dosed no more frequently than every 14 days

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

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

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (June, 2018). Pegfilgrastim-jmdb.  Retrieved June 18, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2018, June). Center for Drug Evaluation and Research. Fulphila® Pegfilgrastim-jmdb injection,for subcutaneous use. Retrieved June 22, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  10/1/2018

MOST RECENT REVIEW DATE:  10/1/2018

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.

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

Acute Radiation Exposure

6 mg weekly x 2 doses

All other indications

6 mg per 14 days