HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-100-005
Topic:
Cetuximab (Erbitux)
Section:
Injections
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
January 2018
 
 

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). Cetuximab (Erbitux) is composed of the Fv regions of a murine and-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab (Erbitux) is produced in mammalian (murine myeloma) cell culture.
Policy Position Coverage is subject to the specific terms of the member's benefit plan.

FDA Indications

 

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

Head and Neck Cancer

  • Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; or
  • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU; or
  • Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.  

Colorectal Cancer

K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests:

 

  • In combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) 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.

J9055

 

 

 

 

 

 


National Comprehensive Cancer Network (NCCN) Indications

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

Colon Cancer

  • Therapy for left-sided only tumors expressing KRAS/NRAS wild-type gene:
    • In combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen; or
    • As a single agent in individuals not appropriate for intensive therapy; or
    • As primary treatment for locally unresectable or medically inoperable disease; or
    • For unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy; or
    • As primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for individuals with imminent or existing obstruction; or
    • For unresectable synchronous metastases of other sites; or
    • As primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX (capecitabine and oxaliplatin) within the past 12 months; or
    • For unresectable metachronous metastases that remain unresectable after primary treatment; or
  • Initial treatment for left-sided only tumors expressing KRAS/NRAS wild-type gene for unresectable synchronous liver and/or lung metastases in combination with:
    • FOLFOX regimen; or
    • FOLFIRI regimen; or
  • Therapy for left-sided only tumors expressing KRAS/NRAS wild-type gene in combination with FOLFOX or FOLFIRI regimen, or as a single agent in individuals not appropriate for intensive therapy:
    • As adjuvant treatment following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease; or
    • As adjuvant treatment following resection and/or local therapy for resectable metachronous metastases in individuals who have received previous chemotherapy or had growth on neoadjuvant chemotherapy; or
    • As adjuvant treatment for unresectable metachronous metastases that converted to resectable disease; or
  • Primary treatment for tumors expressing KRAS/NRAS wild-type gene for individuals with unresectable metachronous metastases and previous adjuvant FOLFOX or CapeOX within the past 12 months:
    • In combination with irinotecan; or
    • In combination with FOLFIRI regimen; or
  • Subsequent therapy for tumors expressing KRAS/NRAS wild-type gene for unresectable advanced or metastatic disease not previously treated with cetuximab or panitumumab:
    • In combination with irinotecan or with FOLFIRI regimen after first progression for disease previously treated with oxaliplatin-based therapy without irinotecan; or
    • In combination with irinotecan after first progression for disease previously treated with irinotecan-based therapy without oxaliplatin; or
    • In combination with irinotecan after second or subsequent progression for disease previously treated with oxaliplatin- and irinotecan-based therapies; or
    • In combination with irinotecan for disease previously treated with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen.

Squamous Cell Skin Cancer

  • Treatment for regional recurrence or distant metastases.

Head and Neck Cancers - Cancer of the Glottic Larynx

  • Primary concurrent chemoradiation as a single agent for:
    • For T3, N0-3 disease requiring (amenable to) total laryngectomy; or
    • For selected T4a individuals who decline surgery; or
  • Sequential chemoradiation as a single agent:
    • For T3, N0-3 disease requiring (amenable to) total laryngectomy following partial response at the primary site to induction chemotherapy; or
    • For selected T4a individuals who decline surgery following partial response at the primary site to induction chemotherapy.

Head and Neck Cancers - Cancer of the Hypopharynx

  • Primary concurrent chemoradiation as a single agent for:
    • T1, N+; or
    • T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy; or
  • Sequential chemoradiation for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy with total laryngectomy, or for T4a, any N disease:
    • Following a partial response at the primary site or improved disease in the neck following induction chemotherapy; or
    • Following a complete response at the primary site and stable or improved disease in the neck following induction chemotherapy.

Head and Neck Cancers - Cancer of the Lip

  • Primary concurrent chemoradiation as a single agent for individuals with T3-4a, N0 or for individuals with any T, N1-3 disease who are candidates for but do not receive surgery.

Head and Neck Cancers - Cancer of the Nasopharynx

  • Primary therapy in combination with carboplatin for any T, any N, M1 disease.

Head and Neck Cancers - Cancer of the Oropharynx

  • Primary concurrent chemoradiation as a single agent for:
    • T2, N1 disease; or
    • T3-4a, N0-1 disease; or
    • Any T, N2-3 disease; or
  • Sequential chemoradiation following induction chemotherapy for:
    • T3-4a, N0-1 disease; or
    • Any T, N2-3 disease.

Head and Neck Cancers - Cancer of the Supraglottic Larynx

  • Primary concurrent chemoradiation as a single agent for:
    • T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy; or
    • T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery; or
    • Consider for T4a, N0-3 disease for individuals who decline surgery; or
  • Sequential chemoradiation as a single agent for:
    • T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy following partial response at the primary site to induction chemotherapy; or
    • T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery following partial response at the primary site to induction chemotherapy; or
    • T4a, N0-3 disease for individuals who decline surgery following a partial response at the primary site to induction chemotherapy.

Head and Neck Cancers - Ethmoid Sinus Tumors

  • Primary concurrent chemoradiation as a single agent for:
    • Newly diagnosed T3-4b disease; or
    • Individuals who decline surgery; or
    • Cancer diagnosed after incomplete resection and gross residual disease.

Head and Neck Cancers - Maxillary Sinus Tumors

  • Consider preoperative concurrent chemoradiation as a single agent for select individuals with T3-4a, N0 disease; or
  • Primary concurrent chemoradiation as a single agent for T4b, any N disease.

Head and Neck Cancers - Occult Primary

  • Initial definitive treatment as a single agent for:
    • Concurrent chemoradiation for greater than or equal to N2 disease; or
    • Sequential chemoradiation following induction chemotherapy.

Head and Neck Cancers - Advanced, Recurrent, Persistent

  • Primary concurrent chemoradiation for non-nasopharyngeal cancer as a single agent for individuals with:
    • Newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, for individuals who are unfit for surgery or locoregional recurrence in individuals who have not received prior radiation therapy (RT) and performance status (PS) 0-2; or
    • Metastatic (M1) disease at initial presentation or recurrent/persistent disease with distant metastases and PS 0-1; or
    • Resectable locoregional recurrence without prior RT; or
    • Unresectable locoregional recurrence or second primary with prior RT; or
  • Sequential chemoradiation following induction chemotherapy in performance status 0-1 individuals with non-nasopharyngeal cancer for:
    • Newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, or individuals who are unfit for surgery; or
    • Unresectable locoregional recurrence in individuals who have not received prior radiation therapy; or
  • Therapy as a:
    • Single agent for individuals with non-nasopharyngeal cancer with newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, with unresectable locoregional recurrence and no prior radiation therapy (RT) or for individuals who are unfit for surgery with performance status (PS) 3; or
    • Single agent (non-nasopharyngeal cancer) in PS 0-2 individuals or in combination (PS 0-1) with carboplatin (non-nasopharyngeal cancer) or (nasopharyngeal cancer) alone, or in combination with cisplatin or carboplatin and fluorouracil , docetaxel, or paclitaxel (non-nasopharyngeal cancer) for metastatic (M1) disease at initial presentation, recurrent/persistent disease with distant metastases, or unresectable locoregional recurrence or second primary with prior RT.

Non-Melanoma Skin Cancers - Basal Cell and Squamous Cell Skin Cancers

  • Treatment for regional recurrence or distant metastases.

Non-Small Cell Lung Cancer (NSCLC)

  • In combination with afatinib as subsequent therapy for metastatic disease in individuals with a known sensitizing EGFR mutation:
    • Who have progressed on EGFR tyrosine kinase inhibitor therapy for asymptomatic disease (without rapid radiologic progression or threatened organ function), symptomatic brain lesions, or isolated symptomatic systemic lesions; or
    • Who are T790M negative, have progressed on EGFR tyrosine kinase inhibitor therapy, and have multiple symptomatic systemic lesions.

Penile Cancer

  • Consider single agent therapy for second-line treatment of metastatic disease in select individuals.

Rectal Cancer

  • Used for tumors expressing KRAS/NRAS wild-type gene in combination with FOLOFOX or FOLFIRI regimen or as a single agent in individuals not appropriate for intensive therapy as:
    • Primary treatment for T3, N0, M0; any T, N1-2, M0; or T4 and/or locally unresectable or medically inoperable disease with no metastases if resection is contraindicated following neoadjuvant therapy; or
    • Primary treatment for unresectable synchronous metastases or medically inoperable disease; or
    • Systemic therapy following primary treatment with chemoradiation or local therapy for symptomatic unresectable synchronous metastases or medically inoperable disease; or
    • Adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in individuals who have received previous chemotherapy or had growth on neoadjuvant chemotherapy; or
    • Primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months; or
    • Adjuvant treatment for unresectable metachronous metastases that converted to resectable disease; or
    • Systemic therapy for unresectable metachronous metastases that remain unresectable after primary treatment; or
  • Primary treatment for tumors expressing KRAS/NRAS wild-type gene for individuals with unresectable metachronous metastases and previous adjuvant FOLFOX or CapeOX within the past 12 months:
    • In combination with irinotecan; or
    • In combination with FOLFIRI regimen; or
  • Subsequent therapy for tumors expressing KRAS/NRAS wild-type gene for unresectable advanced or metastatic disease not previously treated with cetuximab or panitumumab:
    • In combination with irinotecan or with FOLFIRI regimen after first progression for disease previously treated with oxaliplatin-based therapy without irinotecan; or
    • In combination with irinotecan after first progression for disease previously treated with irinotecan-based therapy without oxaliplatin; or
    • In combination with irinotecan after second or subsequent progression for disease previously treated with oxaliplatin- and irinotecan-based therapiesor
    • In combination with irinotecan for disease previously treated with FOLFOXIRI regimen.

The use of cetuximab (Erbitux) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of cetuximab (Erbitux) for any indications other than those listed in this medical policy.

J9055

 

 

 

 

 

 


NOTE: Dosage recommendations per the FDA label.

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

C06.0

C06.2

C06.80

C06.89

C06.9

C08.1

C08.9

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

C17.0

C17.1

C17.2

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C30.0

C30.1

C31.0

C31.1

C31.2

C31.3

C31.8

C31.9

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

C44.01

C44.02

C44.09

C44.111

C44.1121

C44.1122

C44.1191

C44.1192

C44.121

C44.1221

C44.1222

C44.1291

C44.1292

C44.211

C44.212

C44.219

C44.221

C44.222

C44.229

C44.310

C44.311

C44.319

C44.320

C44.321

C44.329

C44.41

C44.42

C44.510

C44.520

C44.521

C44.529

C44.621

C44.622

C44.629

C44.721

C44.722

C44.729

C44.81

C44.82

C44.91

C44.92

C44.99

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

C78.80

C78.89

D37.01

D37.02

D37.030

D37.031

D37.032

D37.039

D37.05

D37.09

D38.0

D38.5

D38.6

Z51.0

Z51.11

Z85.038

Z85.048

Z85.118

Z85.21

Z85.22

Z85.49

Z85.810

Z85.818

Z85.819

Z85.828

 

 

 

 

 

 


Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

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


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links





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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    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.