HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-100-009
Topic:
Cetuximab (Erbitux)
Section:
Injections
Effective Date:
April 1, 2024
Issued Date:
April 1, 2024
Last Revision Date:
February 2024
Annual Review:
February 2024
 
 

Cetuximab (Erbitux®) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR).

Policy Position

Cetuximab (Erbitux) may be considered medically necessary for the following:

Colorectal Cancer

  • As treatment of KRAS wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in ANY of the following:
    • In combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; or
    • In combination with irinotecan in individuals who are refractory to irinotecan-based chemotherapy; or
    • As a single agent in individuals who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan; or

Head and Neck Cancer

  • As treatment in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); or
  • As treatment in combination with platinum-based therapy with fluorouracil for the first-line treatment of individuals with recurrent locoregional disease or metastatic SCCHN; or
  • As a single agent for the treatment of individuals with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed; or

Compendia Sources

Cetuximab (Erbitux) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

The use of cetuximab (Erbitux) not meeting the criteria as indicated in this policy is considered not medically necessary.

J9055

 

 

 

 

 

 




 NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


Related Policies

Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.


Covered Diagnosis codes for J9055

C00.0

C00.1

C00.2

C00.3

C00.4

C00.5

C00.6

C00.8

C00.9

C01

C02.0

C02.1

C02.2

C02.3

C02.4

C02.8

C02.9

C03.0

C03.1

C03.9

C04.0

C04.1

C04.8

C04.9

C05.0

C05.1

C05.8

C05.9

C06.0

C06.2

C06.80

C06.89

C06.9

C09.0

C09.1

C09.8

C09.9

C10.0

C10.1

C10.2

C10.3

C10.4

C10.8

C10.9

C11.0

C11.1

C11.2

C11.3

C11.8

C11.9

C12

C13.0

C13.1

C13.2

C13.8

C13.9

C14.0

C14.2

C14.8

C18.0

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C30.0

C31.0

C31.1

C32.0

C32.1

C32.2

C32.3

C32.8

C32.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C44.00

C44.02

C44.09

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.221

C44.222

C44.229

C44.320

C44.321

C44.329

C44.42

C44.520

C44.521

C44.529

C44.621

C44.622

C44.629

C44.721

C44.722

C44.729

C44.82

C44.92

C60.0

C60.1

C60.2

C60.8

C60.9

C63.7

C63.8

C76.0

C77.0

C78.00

C78.01

C78.02

C78.6

C78.7

D37.01

D37.02

D37.05

D37.09

D38.0

D38.5

D38.6

 

 

 



Evidence based guidelines support the administration of this drug in alternative sites of care such as the home, office or outpatient ambulatory infusion centers. Administration of infusible drugs at alternate sites of care is based upon the professional judgment of the provider, and taken into account the clinical appropriateness for each individual patient.

The use of Cetuximab (Erbitux) 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



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

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.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

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.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





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

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    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.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    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.