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| Medical Policy: | I-100-004 |
| Topic: | Cetuximab (Erbitux) |
| Section: | Injections |
| Effective Date: | May 28, 2018 |
| Issue Date: | May 28, 2018 |
| Last Reviewed: | January 2018 |
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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 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. |
Food and Drug Administration (FDA) Cetuximab (Erbitux) may be considered medically necessary for the following conditions: Head and Neck Cancer Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests:
National Comprehensive Cancer Network (NCCN)
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 therapies; or
- 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.
NOTE: Dosage recommendations per the FDA label. |
| 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 |
- Link to Provider Resource Center for the Medical Policy Update
02/2017, Coverage Criteria Revised for Cetuximab (Erbitux)
03/2018, Coverage Criteria Revised for Cetuximab (Erbitux)
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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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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
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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.
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.
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