Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-88-011
Topic: Granulocyte Colony-Stimulating Factors
Section: Injections
Effective Date: August 20, 2018
Issue Date: August 20, 2018
Last Reviewed: July 2018

The class of drugs known as granulocyte colony stimulating factors (G-CSFs) include: Filgrastim (Neupogen®), Filgrastim-sndz, (Zarxio®), Pegfilgrastim (Neulasta®) (Neulasta® Onpro®), Pegfilgrastim-jmdb (Fulphila™), Tbo-filgrastim (Granix®) and Sargramostim (Leukine®). These drugs are used for the prevention of severe neutropenia, reduce the duration of the neutropenia, prevent febrile neutropenia (FN), and possible infection-related complications in individuals with cancer. FN is defined as a single temperature equal to or greater than 38.3°C, or a temperature equal to or greater than 38.0°C over 1 hour, and neutrophils less than 500 mcL.

G-CSFs are a blood growth factor that stimulates the bone marrow to produce more infection-fighting white blood cells known as neutrophils. These neutrophils are then released into the blood stream where they aid in fighting infection. When neutrophil levels drop and an individual becomes neutropenic, the body is less able to fight off infection. Individuals at high risk to develop these types of conditions may be clinically indicated for the administration of G-CSFs.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Note: Risk assessment for use of G-CSFs includes (not an all-inclusive list) disease type, chemotherapy regimen (high-dose, dose-dense, or standard-dose), risk factors, and treatment intent (curative/adjuvant vs. palliative). Independent clinical judgment should be exercised based on the individual’s situation.

Filgrastim (Neupogen®) may be considered medically necessary for ANY of the following indications:

FDA Indications:

NCCN Indications:

Procedure Codes
J1442


Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 to report the biosimilarity of filgrastim.                                     


Filgrastim-sndz (Zarxio) may be considered medically necessary for ANY of the following indications:

FDA Indications

NCCN Indications:

Procedure Codes
Q5101


Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 to report the biosimilarity of filgrastim.                                     


Filgrastim-aafi (Nivestym™) may be considered medically necessary for ANY of the following:

FDA Indications:

Procedure Codes
J3490


Pegfilgrastim  (Neulasta®) and (Neulasta® Onpro®) may be considered medically necessary for ANY of the following:

FDA Indications:

NCCN Indications:

Procedure Codes
J2505, 96377


Pegfilgrastim-jmdb  (Fulphila™) may be considered medically necessary for the following:

FDA Indication:

Procedure Codes
J3490


Note: Pegfilgrastim-jmdb (Fulphila) is not indicated for the mobilization or peripheral blood progenitor cells for hematopoietic stem cell transplantation.


Tbo-filgrastim (Granix) may be considered medically necessary for ANY of the following:

FDA Indication:

NCCN Indications:

Procedure Codes
J1447


Sargramostim (Leukine) may be considered medically necessary for ANY of the following indications:

FDA Indications:

NCCN Indications

The safety and efficacy of sargramostim have not been assessed in individuals with AML less than 55 years of age.

Liquid solutions containing benzyl alcohol (including liquid sargramostim or lyophilized Leukine reconstituted with bacteriostatic water for injection, USP (0.9% benzyl alcohol)) should not be administered to neonates.

Procedure Codes
J2820


The use of G-CSFs (filgrastim, filgrastim-sndz, filgrastim-aafi, pegfilgrastim, pegfilgrastim-jmdb, tbo-filgrastim and sargramostim) are considered not medically necessary for ANY of the following:

Procedure Codes
J1442, J1447, J2505, J2820, Q5101, J3490


Note: Dosage recommendations per the FDA label.

*Note: Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), and WPSS (Very Low, Low, Intermediate).

**Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines.

 



Place of Service: Outpatient

The administration of G-CSFs is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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