BlueCross BlueShield of Tennessee Medical Policy Manual

Pegfilgrastim

NDC CODE(S)

55513-0190-XX - Neulasta 6 mg prefilled syringe (Amgen)

 

55513-0192-XX - Neulasta 6 mg prefilled syringe Onpro Kit (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Neulasta* – 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

Acute Radiation Exposure

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

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

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 pegfilgrastim for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Pegfilgrastim. Retrieved November 15, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (October, 2016). Pegfilgrastim.  Retrieved November 15, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Pegfilgrastim. Retrieved November 16, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016. April). Center for Drug Evaluation and Research. Neulasta® Pegfilgrastim. Retrieved November 15, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125031s184lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

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

Pegfilgrastim (Neulasta®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Is the individual receiving myelosuppressive chemotherapy associated with a high risk of severe neutropenia (greater than 20% risk of febrile neutropenia)?

If yes, go to question #7

If no, go to question #3

  1. Is the individual receiving myelosuppressive chemotherapy associated with an intermediate risk of severe neutropenia (10% or greater risk of febrile neutropenia) and ANY ONE of the following?

If yes, go to question #7

If no, go to question #4

  1. Did the individual experience a neutropenic complication from a prior cycle of the same chemotherapy?

If yes, go to question #7

If no, go to question #5

  1. Was the individual acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)

If yes, go to question #7

If no, go to question #6

  1. Is the request for supportive care in the posttransplant setting, to decrease risk of infectious complications in ANY ONE of the following?

If yes, go to question #7

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

  1. Is the request for 1 billable unit (1 syringe) per 14 days for dosage of ANY ONE of the following for an authorization period of 4 months?

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 the initial approval criteria in questions 2 through 7?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

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