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Asset Publisher
Erbitux® (cetuximab)
Policy Number: VP-0038
(Intravenous)
Last Review Date: 08/01/2024
Date of Origin: 12/22/2009
Dates Reviewed: 07/2010, 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 03/2021, 05/2021, 09/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023, 03/2024, 05/2024, 8/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization 1,30
Coverage will be provided for 6 months and may be renewed, (unless otherwise specified).
Head and Neck Cancer
- In combination with radiation therapy: Coverage will be provided starting one week prior and for the duration of radiation therapy (up to 8 total weeks).
- Sequential systemic therapy/radiation: Coverage will be provided for up to 12 weeks of therapy.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Erbitux 100 mg/50 mL solution for injection single-dose vial: 1 vial every 7 days
- Erbitux 200 mg/100 mL solution for injection single-dose vial: 5 vials x 1 dose, then 3 vials every 7 days
- Max Units (per dose and over time) [HCPCS Unit]:
- Colorectal Cancer & Head and Neck Cancer: 280 billable units every 28 days
- NSCLC: 130 billable units every 14 days
- Squamous Cell Skin Cancer & Penile Cancer
- Loading Dose: 100 billable units for 1 dose
- Maintenance Dose: 60 billable units every 7 days
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Colorectal Cancer (CRC) † ‡ 1,2,12,13,32
- Will not be used as part of an adjuvant treatment regimen; AND
- Patient has not been previously treated with cetuximab or panitumumab; AND
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-
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- Patient has both KRAS and NRAS mutation negative (wild-type) and BRAF V600E mutation negative (wild-type) disease as determined by an FDA-approved or CLIA-compliant testv; AND
-
- Used as primary treatment for metastatic or unresectable (or medically inoperable) disease; AND
- Used in combination with FOLFIRI †; OR
- Used in combination with CapeOX or FOLFOX §**; AND
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-
-
-
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
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-
- Used in combination with irinotecan §; AND
-
- Patient previously received FOLFOX or CapeOX within the past 12 months; AND
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Used as primary treatment for T3, N Any; T1-2, N1-2; T4, N Any rectal cancer; AND
- Used in combination with CapeOX, FOLFOX, or FOLFIRI; AND
- Used as primary treatment for T3, N Any; T1-2, N1-2; T4, N Any rectal cancer; AND
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-
-
- Used if resection is contraindicated following total neoadjuvant therapy; AND
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
- Used if resection is contraindicated following neoadjuvant/definitive immunotherapy; AND
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease; OR
- Used if resection is contraindicated following total neoadjuvant therapy; AND
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-
- Used as subsequent therapy for advanced or metastatic disease; AND
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-
- Used as a single agent; AND
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- Used as subsequent therapy for advanced or metastatic disease; AND
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-
- Patient has oxaliplatin- and irinotecan-refractory disease †; OR
- Patient has irinotecan-intolerant disease †; OR
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- Used in combination with irinotecan; AND
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-
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- Patient has irinotecan-refractory disease †; OR
- Patient has oxaliplatin-refractory disease or oxaliplatin- and irinotecan-refractory disease ; AND
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
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-
-
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
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- Used in combination with FOLFOX or CapeOX for irinotecan-refractory disease *; AND
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- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
-
-
- Patient has BRAF V600E mutation positive disease as determined by an FDA-approved or CLIA-compliant testv †; AND
- Used in combination with encorafenib; AND
- Used as initial treatment for unresectable metastatic disease after previous FOLFOX or CapeOX within the past 12 months; AND
- Used in combination with encorafenib; AND
- Patient has BRAF V600E mutation positive disease as determined by an FDA-approved or CLIA-compliant testv †; AND
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- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
-
- Used as subsequent therapy for progression after at least one prior line of treatment in the advanced or metastatic disease setting; OR
-
- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has KRAS G12C mutation positive disease as determined by an FDA-approved or CLIA-compliant testv ‡; AND
-
- Used in combination with sotorasib or adagrasib; AND
- Used as initial treatment for unresectable metastatic disease after previous FOLFOX or CapeOX within the past 12 months; AND
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- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
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- Used as initial treatment for unresectable metastatic disease after previous FOLFOX or CapeOX within the past 12 months; AND
- Used in combination with sotorasib or adagrasib; AND
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- Used as subsequent therapy for progression of advanced or metastatic disease; AND
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- Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
- Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
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- Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy
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**May also be used for progression on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status.
§ Colon cancer patients must have left-sided tumors only.
Head and Neck Cancer † ‡ Ф 1,2,25,29-31
- Patient has squamous cell carcinoma; AND
- Used in combination with radiation therapy as a single agent †; OR
- Used as sequential systemic therapy/radiation as a single agent; AND
- Used following induction chemotherapy for one of the following cancers:
- Cancer of the hypopharynx (T4a, N0-3 only)
- Cancer of the oropharynx
- Ethmoid sinus tumors** (for newly diagnosed T3, T4a disease)
- Very advanced head and neck cancers* (non-nasopharyngeal and performance status [PS] 0-1)
- Occult primary cancer (for p16 (HPV)-positive); AND
- N1 (single node >3 cm, or 2 or more ipsilateral nodes ≤6 cm) disease; OR
- N2 disease; OR
- N3 disease; OR
- Used following combination systemic therapy for very advanced head and neck cancers* (non-nasopharyngeal); OR
- Used following induction chemotherapy for one of the following cancers:
- Used as first-line therapy; AND
- Used in combination with platinum-based therapy for unresectable, recurrent/persistent, or metastatic disease †; OR
- Used as a single agent for very advanced head and neck cancer* (non-nasopharyngeal); OR
- Used in combination with paclitaxel with or without platinum-based therapy for very advanced head and neck cancers* (non-nasopharyngeal) AND PS 0-1; OR
- Used in combination with nivolumab or pembrolizumab for very advanced head and neck cancer* (non-nasopharyngeal) AND PS 0-1; OR
- Used as subsequent therapy; AND
- Used as a single agent for unresectable, recurrent/persistent, or metastatic disease †; OR
- Used in combination with carboplatin for cancer of the nasopharynx (T1-4, N0-3, M1 only), if not previously used; OR
- Used in combination with paclitaxel with or without platinum-based therapy for very advanced head and neck cancers* (non-nasopharyngeal) AND PS 0-1; OR
- Used in combination with platinum-based therapy, nivolumab, or pembrolizumab for very advanced head and neck cancer* (non-nasopharyngeal) AND PS 0-1; OR
- Used in combination with carboplatin for very advanced head and neck cancer* (nasopharyngeal) AND PS 0-1
* Very Advanced Head and Neck Cancers include: newly diagnosed locally advanced T4b [M0] disease; newly diagnosed unresectable regional nodal disease, typically N3; metastatic disease at initial presentation [M1]; or recurrent or persistent disease.
** Ethmoid sinus tumors may also have adenocarcinoma, esthesioneuroblastoma, undifferentiated carcinoma (sinonasal undifferentiated carcinoma [SNUC], small cell, or sinonasal neuroendocrine carcinoma [SNEC]), or minor salivary gland histology.
Squamous Cell Skin Cancer ‡ 2,27
- Used as a single agent in combination with radiation therapy; AND
- Patient has locally advanced or unresectable disease; AND
- Used as primary treatment for non-surgical candidates; OR
- Used as additional treatment if positive surgical margins and re-resection not feasible; OR
- Patient has resected high-risk regional disease of the head and neck with pathologic extranodal extension (ENE) or incompletely excised nodal disease; OR
- Patient has regional disease that is unresectable, inoperable, or incompletely resected; OR
- Patient has regional recurrence or distant metastatic disease; OR
- Patient has locally advanced or unresectable disease; AND
- Used as a single agent OR in combination with carboplatin and paclitaxel; AND
- Patient is not a candidate for or has progressed on immune checkpoint inhibitors AND clinical trials; AND
- Patient has locally advanced or unresectable disease; AND
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- Used as primary treatment if curative surgery and curative radiation therapy (RT) are not feasible; OR
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- Used as additional treatment if positive surgical margins and curative surgery and curative RT are not feasible; OR
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- Patient has regional disease that is unresectable, inoperable, or incompletely resected if curative RT is not feasible; OR
- Patient has regional recurrence or distant metastatic disease
- Patient has locally advanced or unresectable disease; AND
- Patient is not a candidate for or has progressed on immune checkpoint inhibitors AND clinical trials; AND
Penile Cancer ‡ 2,26
- Used as a single agent; AND
- Used as subsequent therapy for metastatic or recurrent disease
Non-Small Cell Lung Cancer (NSCLC) ‡ 2,24
- Used in combination with afatinib; AND
- Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
- Used as subsequent therapy; AND
- Patient has EGFR exon 19 deletion or exon 21 L858R or EGFR S768I, L861Q, and/or G719X mutation positive tumors as determined by an FDA-approved or CLIA-compliant testv; AND
- Patient progressed on EGFR tyrosine kinase inhibitor therapy (e.g., erlotinib, afatinib, gefitinib, dacomitinib, osimertinib, etc.); AND
- Patient has asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited* progression; OR
- Patient has multiple symptomatic systemic lesions; AND
- Patient has T790M negative disease; OR
- Patient has T790M positive disease and has progressed on osimertinib therapy
* Limited progression: Up to 3 to 5 progressing sites.
v If confirmed using an FDA approved assay – http://www.fda.gov/companiondiagnostics
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1,30
Coverage may be renewed based upon the following criteria:
- Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions/anaphylactic reactions, cardiopulmonary arrest, pulmonary toxicity/interstitial lung disease, dermatologic toxicity, hypomagnesemia/electrolyte abnormalities, etc.
Head and Neck Cancer (in combination with radiation therapy)
- Patient has not exceeded a maximum of 8 weeks of therapy
Head and Neck Cancer (sequential systemic therapy/radiation)
- Patient has not exceeded a maximum of 12 weeks of therapy
- Dosage/Administration 1,12,13,20-23,29-36
Indication |
Dose |
Colorectal Cancer |
400 mg/m² loading dose intravenously, then 250 mg/m² intravenously every 7 days until disease progression or unacceptable toxicity OR 500 mg/m² intravenously every 14 days until disease progression or unacceptable toxicity |
NSCLC |
500 mg/m² intravenously every 14 days until disease progression or unacceptable toxicity |
Head and Neck Cancer |
In combination with radiation therapy: 400 mg/m² loading dose intravenously 1 week prior to radiation therapy, then 250 mg/m² intravenously every 7 days for the duration of radiation therapy (up to 8 total weeks of therapy) Sequential systemic therapy/radiation: 400 mg/m² loading dose intravenously, then 250 mg/m² intravenously every 7 days for up to 12 weeks of therapy Monotherapy, in combination with paclitaxel, or in combination with platinum-based therapy: 400 mg/m² loading dose intravenously, then 250 mg/m² intravenously every 7 days until disease progression or unacceptable toxicity OR 500 mg/m² intravenously every 14 days until disease progression or unacceptable toxicity In combination with nivolumab: 500 mg/m² intravenously every 14 days until disease progression or unacceptable toxicity In combination with pembrolizumab: 400 mg/m² loading dose intravenously, then 250 mg/m² intravenously every 7 days until disease progression or unacceptable toxicity |
Squamous Cell Skin Cancer & Penile Cancer |
400 mg/m² loading dose intravenously, then 250 mg/m² intravenously every 7 days until disease progression or unacceptable toxicity |
- Billing Code/Availability Information
HCPCS Code:
- J9055 – Injection, cetuximab, 10 mg; 1 billable unit = 10 mg
NDC(s):
- Erbitux 100 mg/50 mL single-dose vial, solution for injection: 66733-0948-xx
- Erbitux 200 mg/100 mL single-dose vial, solution for injection: 66733-0958-xx
- References
- Erbitux [package insert]. Branchburg, NJ; ImClone LLC; September 2021; Accessed July 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) cetuximab. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Bouchahda M, Macarulla G, Lledo F, et al. Efficacy and safety of cetuximab (C) given with a simplified, every other week (q2w), schedule in patients (pts) with advanced colorectal cancer (aCRC): a multicenter, retrospective study. J Clin Oncol. 2008; 26(15S): Abstract 15118. Presented at: The 4th American Society of Clinical Oncology Annual Meeting (ASCO). May 30–June 3, 2008. Chicago, Illinois.
- Mrabti H, La Fouchardiere C, Desseigne F, et al. Irinotecan associated with cetuximab given every 2 weeks versus cetuximab weekly in metastatic colorectal cancer. J Can Res Ther. 2009; 5:272-6.
- Shitara K, Yuki S, Yoshida M, et al. Phase II study of combination chemotherapy with biweekly cetuximab and irinotecan for wild-type KRAS metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines World J Gastroenterol, 2011, April 14; 17(14): 1879-1888
- Pfeiffer P, Bjerregarrd JK, Qvortrup C, et al. Simplification of Cetuximab (Cet) Administration: Double Dose Every Second Week as a 60 Minute Infusion. J Clin Oncol, 2007, 25(18S):4133 [abstract 4133 from 2007 ASCO Annual Meeting Proceedings, Part I].
- Pfeiffer P, Nielsen D, Bjerregaard J, et al. “Biweekly Cetuximab and Irinotecan as Third-Line Therapy in Patients with Advanced Colorectal Cancer after Failure to Irinotecan, Oxaliplatin and 5-Fluorouracil,” Ann Oncol, 2008, 19(6):1141-5.
- Carneiro BA, Ramanathan RK, Fakih MG, et al. Phase II study of irinotecan and cetuximab given every 2 weeks as second-line therapy for advanced colorectal cancer. Clin Colorectal Cancer. 2012 Mar; 11(1):53-9.
- Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
- Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from https://www.hoparx.org/about-us/advocacy-awareness/issue-briefs/.
- Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Colon Cancer. Version 4.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Rectal Cancer. Version 3.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78.
- Vermrorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
- Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7.
- Van Cutsem E, Köhne CH, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
- Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8.
- Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45.
- Samstein RM, Ho AL, Lee NY, et al. Locally advanced and unresectable cutaneous squamous cell carcinoma: outcomes of concurrent cetuximab and radiotherapy. J Skin Cancer. 2014;2014:284582. doi: 10.1155/2014/284582. Epub 2014 Jul 21.
- Maubec E, Petrow P, Scheer-Senyarich I, et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011 Sep 1;29(25):3419-26. doi: 10.1200/JCO.2010.34.1735. Epub 2011 Aug 1.
- Carthon BC, Ng CS, Pettaway CA, et al. Epidermal growth factor receptor-targeted therapy in locally advanced or metastatic squamous cell carcinoma of the penis. BJU Int. 2014 Jun;113(6):871-7. doi: 10.1111/bju.12450.
- Janjigian YY, Smit EF, Groen HJ, et al. Dual inhibition of EGFR with afatinib and cetuximab in kinase inhibitor-resistant EGFR-mutant lung cancer with and without T790M mutations. Cancer Discov. 2014 Sep;4(9):1036-45. doi: 10.1158/2159-8290.CD-14-0326. Epub 2014 Jul 29.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 7.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Head and Neck Cancers. Version 4.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Penile Cancer. Version 1.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Squamous Cell Skin Cancer. Version 1.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2024.
- Kopetz S, Grothey A, Yaeger R, et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.
- Chung C, Li J, Steuer C, et al. Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2022 Jun 1;28(11):2329-2338. doi: 10.1158/1078-0432.CCR-21-3849.
- Mesía R, Vázquez S, Grau JJ, et al; Spanish Head and Neck Cancer Cooperative Group (TTCC). A Phase 2 Open Label, Single-Arm Trial to Evaluate the Combination of Cetuximab Plus Taxotere, Cisplatin, and 5-Flurouracil as an Induction Regimen in Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):289-96.
- Sacco AG, Chen R, Worden FP, et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol 2021;22:883-892.
- Yaeger R, Weiss J, Pelster M, et al. Adagrasib with or without Cetuximab in Colorectal Cancer with Mutated KRAS G12C. N Engl J Med 2023;388:44- 54.
- Carinato H, Burgy M, Ferry R, et al. Weekly Paclitaxel, Carboplatin, and Cetuximab as First-Line Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma for Patients Ineligible to Cisplatin-Based Chemotherapy: A Retrospective Monocentric Study in 60 Patients. Front Oncol. 2021 Oct 27;11:714551. doi: 10.3389/fonc.2021.714551.
- Tahara M, Kiyota N, Yokota T, et al. Phase II trial of combination treatment with paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CSPOR-HN02). Ann Oncol. 2018 Apr 1;29(4):1004-1009. doi: 10.1093/annonc/mdy040.
- Geraghty L, Schultz TE, Hoffman SE, et al. Weekly vs. 3-weekly paclitaxel, carboplatin, and cetuximab (PCC) in recurrent/metastatic head and neck cancer. Mol Clin Oncol. 2021 Nov;15(5):240. doi: 10.3892/mco.2021.2403.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cetuximab: Head and Neck Cancers, HDN134. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed July 2024.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C00.0 |
Malignant neoplasm of external upper lip |
C00.1 |
Malignant neoplasm of external lower lip |
C00.2 |
Malignant neoplasm of external lip, unspecified |
C00.3 |
Malignant neoplasm of upper lip, inner aspect |
C00.4 |
Malignant neoplasm of lower lip, inner aspect |
C00.5 |
Malignant neoplasm of lip, unspecified, inner aspect |
C00.6 |
Malignant neoplasm of commissure of lip, unspecified |
C00.8 |
Malignant neoplasm of overlapping sites of lip |
C00.9 |
Malignant neoplasm of lip, unspecified |
C01 |
Malignant neoplasm of base of tongue |
C02.0 |
Malignant neoplasm of dorsal surface of tongue |
C02.1 |
Malignant neoplasm of border of tongue |
C02.2 |
Malignant neoplasm of ventral surface of tongue |
C02.3 |
Malignant neoplasm of anterior two-thirds of tongue, part unspecified |
C02.4 |
Malignant neoplasm of lingual tonsil |
C02.8 |
Malignant neoplasm of overlapping sites of tongue |
C02.9 |
Malignant neoplasm of tongue, unspecified |
C03.0 |
Malignant neoplasm of upper gum |
C03.1 |
Malignant neoplasm of lower gum |
C03.9 |
Malignant neoplasm of gum, unspecified |
C04.0 |
Malignant neoplasm of anterior floor of mouth |
C04.1 |
Malignant neoplasm of lateral floor of mouth |
C04.8 |
Malignant neoplasm of overlapping sites of floor of mouth |
C04.9 |
Malignant neoplasm of floor of mouth, unspecified |
C05.0 |
Malignant neoplasm of hard palate |
C05.1 |
Malignant neoplasm of soft palate |
C05.8 |
Malignant neoplasm of overlapping sites of palate |
C05.9 |
Malignant neoplasm of palate, unspecified |
C06.0 |
Malignant neoplasm of cheek mucosa |
C06.2 |
Malignant neoplasm of retromolar area |
C06.80 |
Malignant neoplasm of overlapping sites of unspecified parts of mouth |
C06.89 |
Malignant neoplasm of overlapping sites of other parts of mouth |
C06.9 |
Malignant neoplasm of mouth, unspecified |
C09.0 |
Malignant neoplasm of tonsillar fossa |
C09.1 |
Malignant neoplasm of tonsillar pillar (anterior) (posterior) |
C09.8 |
Malignant neoplasm of overlapping sites of tonsil |
C09.9 |
Malignant neoplasm of tonsil, unspecified |
C10.0 |
Malignant neoplasm of vallecula |
C10.1 |
Malignant neoplasm of anterior surface of epiglottis |
C10.2 |
Malignant neoplasm of lateral wall of oropharynx |
C10.3 |
Malignant neoplasm of posterior wall of oropharynx |
C10.4 |
Malignant neoplasm of branchial cleft |
C10.8 |
Malignant neoplasm of overlapping sites of oropharynx |
C10.9 |
Malignant neoplasm of oropharynx, unspecified |
C11.0 |
Malignant neoplasm of superior wall of nasopharynx |
C11.1 |
Malignant neoplasm of posterior wall of nasopharynx |
C11.2 |
Malignant neoplasm of lateral wall of nasopharynx |
C11.3 |
Malignant neoplasm of anterior wall of nasopharynx |
C11.8 |
Malignant neoplasm of overlapping sites of nasopharynx |
C11.9 |
Malignant neoplasm of nasopharynx, unspecified |
C12 |
Malignant neoplasm of pyriform sinus |
C13.0 |
Malignant neoplasm of postcricoid region |
C13.1 |
Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect |
C13.2 |
Malignant neoplasm of posterior wall of hypopharynx |
C13.8 |
Malignant neoplasm of overlapping sites of hypopharynx |
C13.9 |
Malignant neoplasm of hypopharynx, unspecified |
C14.0 |
Malignant neoplasm of pharynx, unspecified |
C14.2 |
Malignant neoplasm of Waldeyer's ring |
C14.8 |
Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx |
C18.0 |
Malignant neoplasm of cecum |
C18.1 |
Malignant neoplasm of appendix |
C18.2 |
Malignant neoplasm of ascending colon |
C18.3 |
Malignant neoplasm of hepatic flexure |
C18.4 |
Malignant neoplasm of transverse colon |
C18.5 |
Malignant neoplasm of splenic flexure |
C18.6 |
Malignant neoplasm of descending colon |
C18.7 |
Malignant neoplasm of sigmoid colon |
C18.8 |
Malignant neoplasm of overlapping sites of large intestines |
C18.9 |
Malignant neoplasm of colon, unspecified |
C19 |
Malignant neoplasm of rectosigmoid junction |
C20 |
Malignant neoplasm of rectum |
C21.8 |
Malignant neoplasm of overlapping sites of rectum, anus and anal canal |
C30.0 |
Malignant neoplasm of nasal cavity |
C31.0 |
Malignant neoplasm of maxillary sinus |
C31.1 |
Malignant neoplasm of ethmoidal sinus |
C32.0 |
Malignant neoplasm of glottis |
C32.1 |
Malignant neoplasm of supraglottis |
C32.2 |
Malignant neoplasm of subglottis |
C32.3 |
Malignant neoplasm of laryngeal cartilage |
C32.8 |
Malignant neoplasm of overlapping sites of larynx |
C32.9 |
Malignant neoplasm of larynx, unspecified |
C33 |
Malignant neoplasm of trachea |
C34.00 |
Malignant neoplasm of unspecified main bronchus |
C34.01 |
Malignant neoplasm of right main bronchus |
C34.02 |
Malignant neoplasm of left main bronchus |
C34.10 |
Malignant neoplasm of upper lobe, unspecified bronchus or lung |
C34.11 |
Malignant neoplasm of upper lobe, right bronchus or lung |
C34.12 |
Malignant neoplasm of upper lobe, left bronchus or lung |
C34.2 |
Malignant neoplasm of middle lobe, bronchus or lung |
C34.30 |
Malignant neoplasm of lower lobe, unspecified bronchus or lung |
C34.31 |
Malignant neoplasm of lower lobe, right bronchus or lung |
C34.32 |
Malignant neoplasm of lower lobe, left bronchus or lung |
C34.80 |
Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
C34.81 |
Malignant neoplasm of overlapping sites of right bronchus and lung |
C34.82 |
Malignant neoplasm of overlapping sites of left bronchus and lung |
C34.90 |
Malignant neoplasm of unspecified part of unspecified bronchus or lung |
C34.91 |
Malignant neoplasm of unspecified part of right bronchus or lung |
C34.92 |
Malignant neoplasm of unspecified part of left bronchus or lung |
C44.00 |
Unspecified malignant neoplasm of skin of lip |
C44.02 |
Squamous cell carcinoma of skin of lip |
C44.09 |
Other specified malignant neoplasm of skin of lip |
C44.121 |
Squamous cell carcinoma of skin of unspecified eyelid, including canthus |
C44.1221 |
Squamous cell carcinoma of skin of right upper eyelid, including canthus |
C44.1222 |
Squamous cell carcinoma of skin of right lower eyelid, including canthus |
C44.1291 |
Squamous cell carcinoma of skin of left upper eyelid, including canthus |
C44.1292 |
Squamous cell carcinoma of skin of left lower eyelid, including canthus |
C44.221 |
Squamous cell carcinoma of skin of unspecified ear and external auricular canal |
C44.222 |
Squamous cell carcinoma of skin of right ear and external auricular canal |
C44.229 |
Squamous cell carcinoma of skin of left ear and external auricular canal |
C44.320 |
Squamous cell carcinoma of skin of unspecified parts of face |
C44.321 |
Squamous cell carcinoma of skin of nose |
C44.329 |
Squamous cell carcinoma of skin of other parts of face |
C44.42 |
Squamous cell carcinoma of skin of scalp and neck |
C44.520 |
Squamous cell carcinoma of anal skin |
C44.521 |
Squamous cell carcinoma of skin of breast |
C44.529 |
Squamous cell carcinoma of skin of other part of trunk |
C44.621 |
Squamous cell carcinoma of skin of unspecified upper limb, including shoulder |
C44.622 |
Squamous cell carcinoma of skin of right upper limb, including shoulder |
C44.629 |
Squamous cell carcinoma of skin of left upper limb, including shoulder |
C44.721 |
Squamous cell carcinoma of skin of unspecified lower limb, including hip |
C44.722 |
Squamous cell carcinoma of skin of right lower limb, including hip |
C44.729 |
Squamous cell carcinoma of skin of left lower limb, including hip |
C44.82 |
Squamous cell carcinoma of overlapping sites of skin |
C44.92 |
Squamous cell carcinoma of skin, unspecified |
C60.0 |
Malignant neoplasm of prepuce |
C60.1 |
Malignant neoplasm of glans penis |
C60.2 |
Malignant neoplasm of body of penis |
C60.8 |
Malignant neoplasm of overlapping sites of penis |
C60.9 |
Malignant neoplasm of penis, unspecified |
C63.7 |
Malignant neoplasm of other specified male genital organs |
C63.8 |
Malignant neoplasm of overlapping sites of male genital organs |
C76.0 |
Malignant neoplasm of head, face and neck |
C77.0 |
Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck |
C78.00 |
Secondary malignant neoplasm of unspecified lung |
C78.01 |
Secondary malignant neoplasm of right lung |
C78.02 |
Secondary malignant neoplasm of left lung |
C78.6 |
Secondary malignant neoplasm of retroperitoneum and peritoneum |
C78.7 |
Secondary malignant neoplasm of liver and intrahepatic bile duct |
D37.01 |
Neoplasm of uncertain behavior of lip |
D37.02 |
Neoplasm of uncertain behavior of tongue |
D37.05 |
Neoplasm of uncertain behavior of pharynx |
D37.09 |
Neoplasm of uncertain behavior of other specified sites of the oral cavity |
D38.0 |
Neoplasm of uncertain behavior of larynx |
D38.5 |
Neoplasm of uncertain behavior of other respiratory organs |
D38.6 |
Neoplasm of uncertain behavior of respiratory organ, unspecified |
Z85.038 |
Personal history of other malignant neoplasm of large intestine |
Z85.118 |
Personal history of other malignant neoplasm of bronchus and lung |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |