70114-0101-XX Udenyca 6 MG/0.6ML SOSY (COHERUS BIOSCIENCES, INC)
Pegfilgrastim-cbqv, 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.
Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells and act as growth factors, stimulating neutrophils and their precursors in the bone marrow and affecting neutrophil progenitor proliferation, differentiation, commitment, and end-cell functional activation. Since these products are pegylated they remain active within the body for longer periods of time than non-pegylated filgrastim products.
Pegfilgrastim-cbqv for the prevention of neutropenia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pegfilgrastim-cbqv for the treatment/prevention of other conditions/diseases is considered investigational.
Pegfilgrastim-cbqv is considered medically appropriate for the prevention of neutropenia from ANY ONE of the following:
Individual 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:
Elderly individual, age 65 or greater
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
Pre-existing neutropenia (ANC ≤ 1000/mm3) or bone marrow involvement with tumor
Individual has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS)
Poor performance status
Poor renal function (creatinine clearance <50)
Liver dysfunction (elevated bilirubin >2.0)
Chronic immunosuppression in the post-transplant setting including organ transplant
Individual who experienced a neutropenic complication from a prior cycle of the same chemotherapy*
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
*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-cbqv is considered medically appropriate for renewal if the individual continues to meet all the initial approval 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
|NOTE: 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. (2018, November). Pegfilgrastim-cbqv. Retrieved June 18, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Udenyca®, pegfilgrastim-cbqv injection, for subcutaneous use. Retrieved November 26, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf
ORIGINAL EFFECTIVE DATE: 4/2/2019
MOST RECENT REVIEW DATE: 4/2/2019
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