67457-0833-XX Fulphila 6 MG/0.6 ML SOSY (MYLAN INSTITUTIONAL)
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.
Pegfilgrastim-jmdb for the prevention of neutropenia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pegfilgrastim-jmdb for the treatment/prevention of other conditions/diseases is considered investigational.
Pegfilgrastim-jmdb is considered medically appropriate for the prevention of neutropenia from ANY ONE of the following:
Prophylactic use in individuals with non-myeloid malignancy for ANY ONE of the following:
Individual is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of 20% or greater **
Individual is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of 10% or greater ** and ANY ONE of the following co-morbidities:
Age > 65 receiving full dose intensity
History of recurrent febrile neutropenia from chemotherapy
Extensive prior exposure to chemotherapy
Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation
Persistent neutropenia (ANC ≤ 1000/mm3)
Bone marrow involvement with tumor
Individual has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS with low CD4 counts)
Recent surgery and/or open wounds
Poor performance status
Renal dysfunction (creatinine clearance <50)
Liver dysfunction (elevated bilirubin >2.0)
Chronic immunosuppression in the post-transplant setting including organ transplant (Note: dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen
Individual who experienced a neutropenic complication from a prior cycle of the same chemotherapy** (Note: dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen
Individual acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
Bone marrow transplantation (BMT) failure or engraftment delay
Peripheral blood progenitor cell (PBPC) mobilization and transplant
*Febrile neutropenia is defined as:
a single temperature >38.3 °C orally or >38.0 °C ver 1 h; AND
neutropenia <500 neutrophils/mcL or <1,000 neutrophils/mcL and a predicted decline to <500 neutrophils/mcL over the next 48 h
** 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.
Pegfilgrastim-jmdb is considered medically appropriate for renewal if the individual continues to meet all the initial approval criteria
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.
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.
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).
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (June, 2018). Pegfilgrastim-jmdb. Retrieved June 6, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Pegfilgrastim-jmdb. Retrieved May 27, 2019 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network (2019) Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors. Version 2.2019. Retrieved June 10, 2019
U. S. Food and Drug Administration. (2019, May). Center for Drug Evaluation and Research. Fulphila® Pegfilgrastim-jmdb injection,for subcutaneous use. Retrieved June 6, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 10/1/2018
MOST RECENT REVIEW DATE: 10/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 0.5 mg