Medicare Advantage

Medical Policy

Notification

Cetuximab (Erbitux®)

Notification Issued Date:

This version of the policy will become effective 12/02/2019.

This policy has been updated to communicate the coverage criteria for cetuximab (Erbitux®), in accordance with the US Food and Drug Administration (FDA) prescribing information and the National Comprehensive Cancer Network (NCCN) Compendia. Revisions have been made to all conditions, including Dosing and Frequency Requirements.

Title:

Cetuximab (Erbitux®)

Policy #:

MA08.031g

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

INDEX OF MEDICALLY NECESSARY INDICATIONS

This policy addresses numerous medically necessary indications for the use of cetuximab (Erbitux®) listed in order of appearance within the Policy section. Please see below for the specific medical necessity criteria. (NOTE: Experimental/Investigational section below must also be reviewed).

Type of cancer	Subtype of cancer
Colorectal Cancer	Metastatic Colorectal Cancer (mCRC) Colon Cancer Rectal Cancer
Head and Neck Cancers	Non-Nasopharyngeal Cancer Ethmoid Sinus Cancer Nasopharyngeal Cancer Oral Cavity Cancer (including Mucosal Lip) Oropharyngeal Cancer Supraglottic Larynx Cancer Glottic Larynx Cancer Hypopharynx Cancer Occult Primary Head and Neck Cancer
Non-Small Cell Lung Cancer
Penile Cancer
Squamous Cell Skin Cancer
Additional Indications

MEDICALLY NECESSARY

COLORECTAL CANCER
Cetuximab (Erbitux) for the treatment of colorectal cancer is considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A and any of the following are met:

Metastatic Colorectal Cancer (mCRC)

Cetuximab (Erbitux) used for the treatment of metastatic colorectal cancer (mCRC) that is Kirsten rat sarcoma (K-Ras) wild-type, epidermal growth factor receptor (EGFR)-expressing, in any of the following:

In combination with FOLFIRI (5-fluorouracil [5FU], leucovorin [LV], and irinotecan) or FOLFOX (5-fluorouracil [5-FU], leucovorin [LV], and oxaliplatin) as first-line treatment
In combination with irinotecan in individuals who are refractory to irinotecan-based chemotherapy (i.e., the tumor response rate was poor/progression was not halted)
As a single agent in individuals who are intolerant to irinotecan or after failure of both irinotecan-based and oxaliplatin-based chemotherapy (i.e., the tumor response rate was poor/progression was not halted)

Colon Cancer

Cetuximab (Erbitux) used in combination with FOLFIRI, CapeOX (capecitabine and oxaliplatin), or FOLFOX for therapy for KRAS/neuroblastoma-ras (NRAS)/b-rapidly accelerated fibrosarcoma (BRAF) wild-type gene and left-sided only tumors (proficient mismatch repair/microsatellite-stable [pMMR/MSS] or ineligible for or progression on checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H]) in individuals appropriate for intensive therapy, in any of the following:

As primary therapy for locally unresectable or medically inoperable disease
As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with imminent or existing obstruction
For synchronous unresectable metastases of other sites
As initial treatment for unresectable metachronous metastases in individuals who have not received previous FOLFOX or CapeOX within the past 12 months, who have received previous 5-FU/LV or capecitabine therapy, or who have not received any previous chemotherapy
For individuals who progressed on nonintensive therapy, except if received previous fluoropyrimidine, with improvement in functional status

Cetuximab (Erbitux) used as primary treatment for unresectable synchronous liver and/or lung metastases (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only) (pMMR/MSS only or dMMR/MSI-H and individual is not a candidate for immunotherapy) in combination with FOLFOX or FOLFIRI regimens
Cetuximab (Erbitux) used in combination with irinotecan or FOLFIRI as initial treatment in individuals with unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only) (pMMR/MSS only) and previous FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux) used as initial treatment in combination with encorafenib for individuals with unresectable metachronous metastases (BRAF V600E mutation positive) (pMMR/MSS only) and previous FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux) used as initial treatment in combination with sotorasib or adagrasib for individuals with unresectable metachronous metastases (KRAS G12C mutation positive) (pMMR/MSS only) and previous FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux) for subsequent therapy for progression of advanced or metastatic disease (KRAS/NRAS/BRAF wild-type and left-sided tumors only) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in any of the following:

In combination with irinotecan, FOLFIRI, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated with oxaliplatin-based therapy without irinotecan
In combination with irinotecan, FOLFOX, CapeOX, or as a single agent for individuals who cannot tolerate irinotecan if previously treated with irinotecan-based therapy without oxaliplatin
In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated with oxaliplatin and irinotecan
In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated without irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

Cetuximab (Erbitux) for subsequent therapy (including for appendiceal adenocarcinoma) in combination with encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation–positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated with any of the following:

Oxaliplatin-based therapy without irinotecan
Irinotecan-based therapy without oxaliplatin
Oxaliplatin and irinotecan

Cetuximab (Erbitux) for subsequent therapy (including for appendiceal adenocarcinoma) in combination with encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation– positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated without any of the following:

Irinotecan or oxaliplatin
Irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

Cetuximab (Erbitux) for subsequent therapy in combination with sotorasib or adagrasib for progression of advanced or metastatic disease (KRAS G12C mutation positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated with any of the following:

Oxaliplatin-based therapy without irinotecan
Irinotecan-based therapy without oxaliplatin
Oxaliplatin and irinotecan

Cetuximab (Erbitux) for subsequent therapy in combination with sotorasib or adagrasib for progression of advanced or metastatic disease (KRAS G12C mutation positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated without any of the following:

Irinotecan or oxaliplatin
Irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

Rectal Cancer

Cetuximab (Erbitux) used in combination with FOLFIRI, CapeOX, or FOLFOX for tumors that express the KRAS/NRAS/BRAF wild-type gene only (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals appropriate for intensive therapy, in any of the following:

As primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant or total neoadjuvant therapy (pMMR/MSS only or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) or neoadjuvant/definitive immunotherapy (dMMR/MSI-H only)
As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction
As primary treatment for synchronous unresectable metastases of other sites
As primary treatment for unresectable isolated pelvic/anastomotic recurrence
As initial treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous 5-FU/LV or capecitabine therapy, or who have not received any previous chemotherapy
For individuals who progressed on nonintensive therapy, except if received previous fluoropyrimidine, with improvement in functional status

Cetuximab (Erbitux) as primary treatment of synchronous liver only and/or lung only metastases (KRAS/NRAS/BRAF wild-type gene only) (pMMR/MSS only or dMMR/MSI-H only and not a candidate for immunotherapy) that are unresectable or medically inoperable, in combination with FOLFIRI or FOLFOX
Cetuximab (Erbitux), as initial treatment, used in combination with irinotecan or FOLFIRI in individuals with unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene only) (pMMR/MSS only) and previous FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux) as initial treatment, used in combination with sotorasib or adagrasib for individuals with unresectable metachronous metastases (KRAS G12C mutation–positive) (pMMR/MSS only) and previous FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux), as initial treatment, used in combination with encorafenib for individuals with unresectable metachronous metastases (BRAF V600E mutation–positive) (pMMR/MSS only) and previous adjuvant FOLFOX or CapeOX within the past 12 months
Cetuximab (Erbitux) as subsequent therapy for progression of advanced or metastatic disease (KRAS/NRAS/BRAF wild-type gene only) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H), in any of the following:

In combination with irinotecan, FOLFIRI, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated with oxaliplatin-based therapy without irinotecan
In combination with irinotecan, FOLFOX, CapeOX, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated with irinotecan-based therapy without oxaliplatin
In combination with irinotecan, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated with oxaliplatin and irinotecan
In combination with irinotecan, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated without irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

Cetuximab (Erbitux) for subsequent therapy in combination with encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation–positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated with any of the following:

Oxaliplatin-based therapy without irinotecan
Irinotecan-based therapy without oxaliplatin
Oxaliplatin and irinotecan

Cetuximab (Erbitux) for subsequent therapy in combination with encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation–positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated without any of the following:

Irinotecan or oxaliplatin
Irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

Cetuximab (Erbitux) for subsequent therapy in combination with sotorasib or adagrasib for progression of advanced or metastatic disease (KRAS G12C mutation–positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated with any of the following:

Oxaliplatin-based therapy without irinotecan
Irinotecan-based therapy without oxaliplatin
Oxaliplatin and irinotecan

Cetuximab (Erbitux) for subsequent therapy in combination with sotorasib or adagrasib for progression of advanced or metastatic disease (KRAS G12C mutation–positive) (pMMR/MSS or ineligible for or progression on checkpoint inhibitor immunotherapy for dMMR/MSI-H) in individuals previously treated without any of the following:

Irinotecan or oxaliplatin
Irinotecan or oxaliplatin followed by FOLFOX or CapeOX with or without bevacizumab

HEAD AND NECK CANCER

Cetuximab (Erbitux) for the treatment of head and neck cancer is considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A and any of the following indications are met:

Cetuximab (Erbitux) used in combination with radiation therapy (RT) is indicated for the initial treatment of locally or regionally advanced squamous cell cancer of the head and neck
Cetuximab (Erbitux) used in combination with platinum-based therapy with 5-FU is indicated for the first-line treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in individuals who previously failed or are refractory to platinum-based chemotherapy

Non-nasopharyngeal Cancer

Cetuximab (Erbitux) is indicated for the treatment of non-nasopharyngeal cancer, in any of the following:

Administered as a single agent given weekly as sequential systemic therapy/RT following induction systemic therapy for individuals with performance status (PS) 0-1 who have any of the following:

Newly diagnosed T4b, N0-3, M0 disease
Newly diagnosed unresectable nodal disease with no metastases
Newly diagnosed nonmetastatic disease and who are unfit for surgery
Unresectable locoregional recurrence or persistent disease and who have not received prior RT

Administered as a single agent given weekly as sequential systemic therapy/RT following combination systemic therapy in individuals with resectable locoregional recurrence or persistent disease and who have not received prior RT
Systemic first-line treatment as a single agent for individuals with any of the following:

PS 3 for newly diagnosed T4b, N0-3, M0 disease, newly diagnosed unresectable nodal disease with no metastases, or for individuals with newly diagnosed nonmetastatic disease who are unfit for surgery
PS 0-3 for metastatic (M1) disease at initial presentation
PS 3 and unresectable locoregional recurrence or unresectable persistent disease without prior RT
PS 0-3 and unresectable locoregional recurrence with prior RT, unresectable second primary with prior RT, or unresectable persistent disease with prior RT, or recurrent/persistent disease with distant metastases

Subsequent-line treatment as a single agent for individuals with any of the following:

Alternate option for PS 0-3 for metastatic (M1) disease at initial presentation
PS 3 and unresectable locoregional recurrence or unresectable persistent disease without prior RT
Alternate option for PS 0-3 and unresectable locoregional recurrence with prior RT, unresectable second primary with prior RT, or unresectable persistent disease with prior RT, or recurrent/persistent disease with distant metastases

Administered as a single agent as postoperative systemic therapy/RT if cisplatin ineligible for positive margin and/or extranodal extension in either of the following:

Resectable locoregional recurrence or persistent disease without prior RT
Resectable locoregional recurrence, second primary, or persistent disease with prior RT

As combination systemic first-line, or subsequent-line treatment, in individuals with PS 0-1, given:

As part of any of the following regimens:

5-FU and cisplatin
5-FU and carboplatin
Docetaxel and cisplatin
Docetaxel and carboplatin
Paclitaxel and cisplatin
Paclitaxel and carboplatin
Cisplatin
Nivolumab
Pembrolizumab
Paclitaxel

For any of the following:

Metastatic (M1) disease at initial presentation
Recurrent/persistent disease with distant metastases
Unresectable locoregional recurrence with prior RT
Unresectable second primary with prior RT
Unresectable persistent disease with prior RT

As combination systemic therapy for resectable locoregional recurrence or persistent disease without prior RT given as part of any of the following regimens:

5-FU and cisplatin
5-FU and carboplatin
Docetaxel and cisplatin
Docetaxel and carboplatin
Paclitaxel and cisplatin
Paclitaxel and carboplatin
Cisplatin
Nivolumab
Pembrolizumab
Paclitaxel

Ethmoid Sinus Cancer

Cetuximab (Erbitux) administered as a single agent given weekly is indicated for the treatment of cancer of the ethmoid sinus as sequential systemic therapy/RT following a complete response to induction chemotherapy for newly diagnosed T3, T4a disease

Nasopharynx Cancer

Cetuximab (Erbitux) used in combination with carboplatin is indicated for the treatment of very advanced cancer of the nasopharynx as systemic first-line or subsequent-line (if not previously used) treatment in individuals with PS 0-1 for any of the following:

Recurrent/persistent disease with distant metastases
Unresectable locoregional recurrence with prior RT
Unresectable second primary with prior RT
Unresectable persistent disease with prior RT

Cetuximab (Erbitux) used in combination with carboplatin is indicated as first-line systemic therapy for the treatment of T1-4, N0-3, M1 disease for either of the following:

Oligometastatic disease and PS 0-2
Widely metastatic disease and good PS (0-2)

Cetuximab (Erbitux) used in combination with carboplatin, if not previously used, as subsequent-line systemic therapy for the treatment of T1-4, N0-3, M1 disease for either of the following:

Oligometastatic disease and PS 0-2
Widely metastatic disease and good PS (0-2)

Oral Cavity Cancer (including Mucosal Lip)

Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of cancer of the oral cavity (including mucosal lip) as postoperative systemic therapy/RT in individuals who are cisplatin ineligible with any of the following:

Extranodal extension with or without positive margin for T1-3, N0-3; or T4a, N0-3 disease
With positive margins for T3, N0; T1-3, N1-3; or T4a, N0-3 disease
May be considered with positive margin in T1-2, N0 disease

Oropharynx Cancer

Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of cancer of the oropharynx for any of the following:

As primary concurrent systemic therapy/RT for either p16-negative disease:

T3-4a, N0-1 disease
T1-4a, N2-3 disease

As primary concurrent systemic therapy/RT for either p16 (human papillomavirus [HPV]-positive disease):

T0-2, N1 (single node >3 cm, or 2 or more ipsilateral nodes 6 cm or less), T0-2, N2 or T3, N0-2 disease (treatment modality preferred if clinical evidence of fixed or matted nodes or obvious extranodal extension)
T0-3, N3 or T4, N0-3 disease (National Comprehensive Cancer Network [NCCN] preferred)

As sequential systemic therapy/RT given weekly following induction chemotherapy for either p16-negative disease:

T3-4a, N0-1 disease
T1-4a, N2-3 disease

As sequential systemic therapy/RT given weekly following induction chemotherapy for either p16 (human papillomavirus [HPV])-positive disease:

T0-2, N1 (single node >3 cm, or two or more ipsilateral nodes 6 cm or less), T0-2, N2 or T3, N0-2 disease
T0-3, N3 or T4, N0-3 disease

Supraglottic Larynx Cancer

Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of cancer of the supraglottic larynx, in either of the following:

Following a partial response at the primary site to induction chemotherapy given weekly for any of the following:

T3, N0 and most T3, N1-3 disease requiring (amenable to) total laryngectomy
T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery
T4a, N0-3 disease for individuals who decline surgery

As postoperative systemic therapy/RT if cisplatin ineligible for either of the following:

Most individuals with T1-2, N0 and selected T3 disease amenable to larynx-preserving (conservation) surgery for either of the following:

Extranodal extension
May be considered for discovery of positive node for disease with a positive margin

For individuals with extranodal extension and/or positive margin for any of the following:

T3, N0 and most T3, N1-3 disease requiring (amenable to) total laryngectomy
T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery
T4a, N0-3 disease
T1-2, N+ and T3-4a, N0-3 disease following surgery with less than partial response at the primary site to induction chemotherapy

Glottic Larynx Cancer

Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of cancer of the glottic larynx, in either of the following:

Following partial response at the primary site to induction chemotherapy given weekly for either of the following:

T3, N0-3 disease requiring (amenable to) total laryngectomy
Selected individuals with T4a disease who decline surgery

As postoperative systemic therapy/RT in individuals ineligible for cisplatin with extranodal extension in any of the following:

For T1-2, N0 or select T3, N0 disease amenable to larynx-preserving (conservation) surgery
And/or positive margin for T3, N0-3 disease requiring (amenable to) total laryngectomy
And/or positive margin for T3, N0-3 disease following laryngectomy and less than partial response at the primary site to induction chemotherapy
And/or positive margin for T4a, N0-3 disease

Hypopharynx Cancer

Cetuximab (Erbitux) administered as a single agent is indicated for the treatment of cancer of the hypopharynx, in any of the following:

As primary concurrent systemic therapy/RT or induction chemotherapy for either of the following:

T1, N+ disease
T2-3, N0-3 disease requiring (amenable to) pharyngectomy with partial or total laryngectomy

As sequential systemic therapy/RT given weekly for T4a, N0-3 disease for either of the following:

A partial response at the primary site and stable or improved disease in the neck following induction chemotherapy
A complete response at the primary site and stable or improved disease in the neck following induction chemotherapy

As postoperative systemic therapy/RT in individuals who are cisplatin ineligible with any of the following:

Extranodal extension with or without positive margin for most T1, N0 or selected T2, N0 tumors amenable to larynx-preserving (conservation) surgery
May be considered with positive margin for T2, N0 tumors amenable to larynx-preserving (conservation) surgery
Extranodal extension and/or positive margin and any of the following:

T1, N+ or T2-3, N0-3 disease requiring (amenable to) pharyngectomy with partial or total laryngectomy
T1, N+ or T2-3, N0-3 disease with partial response and stable or improved disease in the neck or less than partial response at the primary site following induction chemotherapy
T4a, N0-3 disease
T4a, N0-3 disease with less than partial response at the primary site following induction chemotherapy

Occult Primary Head and Neck Cancer

Cetuximab (Erbitux) administered as a single agent for occult primary head and neck cancer, in any of the following:

For initial definitive treatment as sequential systemic therapy/RT given weekly following induction chemotherapy for N2-3 disease with any of the following histology:
- Poorly differentiated or nonkeratinizing squamous cell
- Anaplastic (not thyroid)
- Squamous cell carcinoma
- Not otherwise specified (NOS)
As primary concurrent systemic therapy/RT for p16 (HPV)-positive disease in any of the following:

N1 (single node >3 cm, or two or more ipsilateral nodes 6 cm or less) disease
N2 disease
N3 disease (NCCN preferred)

As postoperative systemic therapy/RT if cisplatin ineligible for disease with extranodal extension after neck dissection of disease in levels IV or V with adenocarcinoma histology of neck node, thyroglobulin and calcitonin negative
As sequential systemic therapy/RT given weekly following induction chemotherapy for p16 (HPV)-positive disease in either of the following:
- N1 (single node >3 cm, or two or more ipsilateral nodes 6 cm or less) disease
- N2-3 disease

NON-SMALL CELL LUNG CANCER (NSCLC)

Cetuximab (Erbitux) for the treatment of NSCLC is considered medically necessary and, therefore, covered, when the dosing and frequency requirements listed in Attachment A are met, and is used in combination with afatinib as subsequent therapy for recurrent (excluding locoregional recurrence or symptomatic local disease with no evidence of disseminated disease; however, including mediastinal lymph node recurrence with prior RT), advanced or metastatic disease in individuals with EGFR exon 19 deletion or exon 21 L858R or EGFR S768l, L861Q, and/or G719X mutation–positive disease, for any of the following:

Who have progressed on EGFR tyrosine kinase inhibitor therapy for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited progression
Who are T790M negative, have progressed on EGFR tyrosine kinase inhibitor therapy, and have multiple symptomatic systemic lesions
Who are T790M positive, who have progressed on osimertinib, and have multiple symptomatic systemic lesions

PENILE CANCER

Cetuximab (Erbitux) for the treatment of penile cancer is considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A are met and is used as a single agent as subsequent-line systemic therapy for metastatic/recurrent disease, especially if not treated with a similar class of agent.

SQUAMOUS CELL SKIN CANCER

Cetuximab (Erbitux) for the treatment of squamous cell skin cancer is considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A are met,and is used in either of the following:

As a single agent with concurrent RT for any of the following:

For locally advanced or unresectable disease as either of the following:

Primary treatment for nonsurgical candidates
Additional treatment if positive surgical margins and re-resection not feasible

Resected high-risk regional disease of the head and neck (pathologic extranodal extension [ENE] or incompletely excised nodal disease)
Regional disease that is unresectable, inoperable, or incompletely resected
Regional recurrence or distant metastatic disease

As a single agent or in combination with carboplatin and paclitaxel if ineligible for, or progressed on, immune checkpoint inhibitors and clinical trials as treatment in any of the following:

For locally advanced or unresectable disease as either of the following:

Primary treatment if curative surgery and curative RT are not feasible
Additional treatment if positive surgical margins and curative surgery and curative RT are not feasible

Regional disease that is unresectable, inoperable, or incompletely resected if curative RT not feasible
Regional recurrence or distant metastatic disease

ADDITIONAL INDICATIONS

In accordance with the Centers for Medicare & Medicaid Services (CMS) and in addition to the indications above, cetuximab (Erbitux), as a part of anti-cancer chemotherapy regimen, is covered for the following Micromedex Category IIb indications when the dosing and frequency requirements listed in Attachment A and any of the following indications are met:

As treatment of gastric and gastroesophageal junction cancer when either of the following indications are met:

In combination with CapeOX is indicated in individuals with untreated metastatic or locally advanced disease
In combination with FOLFIRI or FOLFOX in individuals with metastatic disease

In combination with FOLFOX or FOLFIRI used as first-line therapy for EGFR-expressing nonresectable advanced or metastatic CRC (no central nervous system metastases)
In combination with irinotecan for the treatment of mCRC, EGFR-expressing disease in individuals who failed both fluoropyrimidine- and oxaliplatin-based regimens
Either alone or in combination with irinotecan for the treatment of refractory mCRC, non-EGFR expressing disease
As treatment of advanced or metastatic NSCLC, in either of the following:
- As first-line treatment with any of the following:
- As subsequent-line treatment as monotherapy for individuals previously treated with a platinum-containing regimen who have not previously been treated with either anti-EGFR therapy or a monoclonal antibody
In combination with platinum-based therapy for the treatment of metastatic or recurrent squamous cell carcinoma of the head and neck in disease that is refractory to platinum-based therapy

EXPERIMENTAL/INVESTIGATIONAL

All other uses of cetuximab (Erbitux) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on Off-label Coverage for Prescription Drugs and Biologics.

DOSING AND FREQUENCY REQUIREMENTS

Refer to Attachment A for dosing and frequency requirements for cetuximab (Erbitux).

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of cetuximab (Erbitux). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of cetuximab (Erbitux) outside of the Dosing and Frequency Requirements listed in this Policy. For a list of Company-recognized pharmacology compendia, view our policy on Off-label Coverage for Prescription Drugs and Biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct postpayment review and audit procedures for any claims submitted for cetuximab (Erbitux).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of cetuximab (Erbitux) is requested outside of the Dosing and Frequency Guidelines listed in this Policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

Guidelines

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when cetuximab (Erbitux) is covered under a member's medical benefit (Part B benefit). It does not address instances when cetuximab (Erbitux) is covered under a member’s pharmacy benefit (Part D benefit).

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cetuximab (Erbitux) may be covered under the medical benefits of the Company’s Medicare Advantage products when medical necessity criteria and dosing and frequency requirements listed in this medical policy are met.

DRUG ADMINISTRATION

Cetuximab (Erbitux) is administered by intravenous (IV) infusion and should not be given as an IV push or bolus.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The ECOG has developed the ECOG Performance Status; it was originally published in 1982 in the American Journal of Clinical Oncology*. ECOG states, "These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. They are included here for health care professionals to access."

ECOG Performance Status
Grade	ECOG
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
2	Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3	Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self-care: Totally confined to bed or chair
5	Dead

*Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA's approval of cetuximab (Erbitux) was initially issued on February 12, 2004. Supplemental approvals have since been issued.

PEDIATRIC USE

The safety and effectiveness of cetuximab (Erbitux) in pediatric individuals have not been established.

Description

Cetuximab (Erbitux) is a recombinant monoclonal antibody and an antineoplastic agent that works differently than standard chemotherapy or hormonal therapy. It also has been shown to enhance the antitumor effects of other chemotherapy. Monoclonal antibodies may be used to target and destroy certain cancer cells while causing little harm to normal cells. Cetuximab (Erbitux) binds to the extracellular domain of the human epidermal growth factor receptor (EGFR), which is expressed in many human cancers, including head and neck cancer and colon and rectum cancer. Cetuximab (Erbitux), by attaching itself to the EGFR of cancer cells, is able to prevent the receptors from being activated. Through various mechanisms, it is able to inhibit cell division, promote cell death, and inhibit angiogenesis and metastasis.

METASTATIC COLORECTAL CANCER

The US Food and Drug Administration (FDA) has issued several approvals for its use in metastatic colorectal cancer (mCRC). Cetuximab (Erbitux) received initial FDA approval in 2004 for the treatment of EGFR-expressing mCRC either in combination with irinotecan or as a single agent, when there is an intolerance to irinotecan. An FDA approval in 2008 expanded the use of cetuximab (Erbitux) as a single agent in mCRC after failure of both irinotecan-based and oxaliplatin-based chemotherapy. A more recent FDA approval, in 2012, allows for the use of cetuximab (Erbitux) in combination with FOLFIRI (irinotecan, 5-fluorouracil [5-FU], leucovorin) for first-line treatment of mCRC.

Cetuximab (Erbitux) therapy in mCRC is further guided by the status of the Kirsten rat sarcoma viral oncogene homolog (KRAS) gene and neuroblastoma RAS (NRAS) gene. When KRAS or NRAS mutations exist, the genes are said to be abnormal or mutated. When no mutations exist, KRAS/NRAS are said to be normal or wild-type (nonmutated). An FDA-approved test has been developed to determine the KRAS/NRAS mutation status of mCRC. The FDA, in addition to the National Comprehensive Cancer Network (NCCN), warns that analysis should be performed "in laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results."

Van Cutsem et al. (2007, 2008) published literature detailing a clinical trial to evaluate the safety and efficacy of cetuximab (Erbitux) plus chemotherapy versus chemotherapy alone for individuals with untreated mCRC. The phase III multicenter study (NCT00154102) consisted of randomized, open-label, parallel assignment of individuals to receive either active treatment (cetuximab [Erbitux] 400 mg/m² as the initial dose followed by 250 mg/m² weekly for the duration of the study) with chemotherapy or chemotherapy alone until disease progression or toxicity developed. The chemotherapy consisted of FOLFIRI (5-fluorouracil [5-FU], leucovorin [LV], and irinotecan). A total of 1217 individuals were enrolled by the time of the 2007 publication with 608 assigned to receive active treatment with chemotherapy and 609 assigned to receive chemotherapy only. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), response rate (RR), duration of response (DOR), quality of life (QOL) measures, and safety measures. The median PFS for the active treatment arm was 8.9 months versus 8.1 months for the chemotherapy only arm (p=0.0358). The median OS for the active treatment arm was 19.6 months versus 18.5 months for the chemotherapy-only arm. The RR for the active treatment arm was 46.9 percent versus 38.7 percent for the chemotherapy-only arm (p=0.005). The grade 3 or higher reactions did not differ significantly between the two arms except for skin reactions, infusion-related reactions, and diarrhea, which occurred in the active treatment arm more frequently than the chemotherapy-only arm.

Jonker et al. (2007) conducted a clinical trial to evaluate the safety and efficacy of cetuximab (Erbitux) plus best supportive care versus best supportive care (BSC) alone for individuals with epidermal growth factor receptor (EGFR)-positive mCRC. The phase III multicenter study(NCT00079066) consisted of randomized, open-label, parallel assignment of individuals to receive either active treatment (cetuximab [Erbitux] 400 mg/m² as the initial dose followed by 250 mg/m² weekly for the duration of the study) with BSC or BSC alone until disease progression or toxicity developed. A total of 572 individuals were enrolled with 287 assigned to receive active treatment with BSC and 285 assigned to receive BSC only. The primary endpoint was OS. Secondary endpoints included PFS, RR, QOL measures, and safety measures. The median OS for the active treatment arm was 6.1 months versus 4.6 months for the BSC-only arm (p=0.0046). The PFS was statistically higher in the active treatment arm versus the BSC arm (p<0.001). The RR was statistically higher in the active treatment arm versus the BSC arm (p<0.001).

HEAD AND NECK CANCERS

In 2006, the FDA issued a supplemental approval for the use of cetuximab (Erbitux) in certain types of locally or regionally advanced, recurrent, or metastatic squamous cell head and neck cancers, either as a single agent or in combination with radiation therapy. In 2011, cetuximab (Erbitux) was indicated for use in combination with platinum-based therapy with 5-FU for the first-line treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck.

Bonner et al. (2006) conducted a clinical trial to evaluate the safety and efficacy of cetuximab (Erbitux) plus radiation therapy (RT) versus RT alone for individuals with locoregionally advanced head and neck cancer. The phase III multicenter study (NCT00004227) consisted of randomized, open-labeled, parallel assignment of individuals to receive either active treatment (cetuximab [Erbitux] 400 mg/m² as the initial dose followed by 250 mg/m² weekly for the duration of the RT) with RT or RT alone. For both arms, the RT dose was further randomized to one of three groups: 1.) RT once daily 5 days a week for 3.5 weeks followed by RT twice daily 5 days a week for 2.5 weeks. 2.) RT once daily 5 days a week for 7 weeks. 3.) RT twice daily 5 days a week for 6 to 6.5 weeks. A total of 424 individuals were enrolled with 211 assigned to receive active treatment with RT and 213 assigned to receive RT only. The primary endpoint was the DOR. Secondary endpoints were OS, PFS, RR, and safety measures. The median DOR was 24.4 months for the active treatment arm versus 14.9 months for the RT-only arm (p=0.005). The median OS was 49.0 months for the active treatment arm versus 29.3 months for the RT-only arm (p=0.03). The active treatment significantly prolonged PFS versus RT only (p=0.006). The incidence of grade 3 or higher reactions did not differ significantly between the active treatment arm versus RT-only except for acneiform rash and transfusion reactions.

Vermorken et al. (2007) conducted a clinical trial to evaluate the safety and efficacy of cetuximab (Erbitux) plus platinum-based chemotherapy versus chemotherapy alone for individuals who had not received treatment for recurrent or metastatic head and neck cancer. The phase III multicenter study (NCT00122460) consisted of randomized, open-label, parallel assignment of individuals to receive either active treatment (cetuximab [Erbitux] 400 mg/m² as the initial dose followed by 250 mg/m² weekly for the duration of the study) with chemotherapy or chemotherapy alone for a maximum of six cycles. If an individual in the active treatment arm achieved stable disease, they were able to continue to receive cetuximab (Erbitux) until disease progression or toxicity developed. The chemotherapy consisted of 5-FU along with either cisplatin or carboplatin. A total of 442 individuals were enrolled with 222 assigned to receive active treatment with chemotherapy and 220 assigned to receive chemotherapy only. The primary endpoint was OS. Secondary endpoints included PFS, RR, disease control, time to treatment failure, DOR, QOL measures, and safety measures. The median OS was 10.1 months for the active treatment arm versus 7.4 months for the chemotherapy-only arm (p=0.04). The median PFS was 5.6 months for the active treatment arm versus 3.3 months for the chemotherapy-only arm (p<0.001). The RR for the active treatment arm was 36 percent versus 20 percent for the chemotherapy-only arm (p<0.001). The incidence of grade 3 or 4 adverse events was similar in both arms except for the rate of sepsis in the active treatment arm.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

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Azzoli CG, Baker S Jr, Temin S, et al. American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non–small-cell lung cancer. J Clin Oncol. 2009;27(36):6251-6266.

Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F, et al. Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res. 2007;67(6):2643-2648.

Bokemeyer C, Bondarenko I, Hartmann JT, et al. KRAS status and efficacy of first-line treatment of patients with metastatic colorectal (mCRC) with FOLFOX with or without cetuximab: the OPUS experience. J Clin Oncol. 2008;26(15 suppl):abstract 4000.

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;354(6):567-578.

Butts CA, Bodkin D, Middleman EL, et al. Randomized phase II study of gemcitabine plus cisplatin or carboplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non small-cell lung cancer. J Clin Oncol. 2007;25(36):5777-5784.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for anti-cancer chemotherapy for colorectal cancer (110.17). Effective date: 01/28/2005. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=291&ncdver=1&bc=AAAAIAAAAAAA&. Accessed December 26, 2023.

De Roock W, Piessevaux H, De Schutter J, et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol. 2008;19(3):508-515.

Di Fiore F, Blanchard F, Charbonnier F, et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer. 2007;96(8):1166-1169.

ECOG-ACRIN Cancer Research Group. ECOG performance status. [ECOG Web site]. Available at: https://ecog-acrin.org/resources/ecog-performance-status. Accessed December 26, 2023.

Elsevier's Clinical Pharmacology Compendium. Cetuximab (Erbitux^®). [Clinical Key Web site]. 11/07/2023. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed December 26, 2023.

Erbitux^® (cetuximab) [prescribing information]. 09/2021. ImClone LLC, Eli Lilly and Company. Available at: https://uspl.lilly.com/erbitux/erbitux.html#pi. Accessed December 26, 2023.

Hanna N, Lilenbaum R, Ansari R, et al. Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer. J Clin Oncol. 2006;24(33):5253-5258.

Helwick C. Cetuximab confers survival benefit in all-RAS wild-type colorectal tumors. The ASCO Post. December 1, 2013. Available at: https://www.ascopost.com/issues/december-1,-2013/cetuximab-confers-survival-benefit-in-all-ras-wild-type-colorectal-tumors.aspx. Accessed December 26, 2023.

Helwick C. Time to think beyond KRAS in metastatic colorectal cancer. The ASCO Post. December 1, 2013. Available at: https://www.ascopost.com/issues/december-1,-2013/time-to-think-beyond-kras-in-metastatic-colorectal-cancer.aspx. Accessed December 26, 2023.

Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007;357(20):2040-2048.

Khambata-Ford S, Garrett CR, Meropol NJ, et al. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol. 2007;25(22):3230-3237.

Lexi-Drugs Compendium. Cetuximab (Erbitux^®). [LexiComp Web site]. 12/05/2023. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed December 26, 2023.

Lievre A, Bachet JB, Boige V, et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol. 2008;26(3):374-379.

Lynch TJ, Patel T, Dreisbach L, et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol. 2010;28(6):911-917.

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National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^® - Rectal Cancer. V6.2023. [NCCN website]. 11/16/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. Accessed December 26, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^® - Squamous Cell Skin Cancer. V1.2024. [NCCN website]. 11/09/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed December 26, 2023.

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Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009;373(9674):1525-1531.

Punt CJ, Tol J, Rodenburg CJ, et al. Randomized phase III study of capecitabine, oxaliplatin, and bevacizumab with or without cetuximab in advanced colorectal cancer (ACC), the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). J Clin Oncol. 2008;26(15 suppl);abstract LBA4011.

Rosell R, Robinet G, Szczesna A, et al. Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Ann Oncol. 2008;19(2):362-369.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Erbitux^® (cetuximab). Prescribing information. [FDA Web site]. 09/24/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed December 26, 2023.

Van Cutsem E, Lang I, D'haens G, et al. KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: the CRYSTAL experience. J Clin Oncol. 2008;26(15 suppl):abstract 2.

Van Cutsem E, Nowacki M, Lang I, et al. Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): the CRYSTAL trial. J Clin Oncol. 2007;25(18 suppl):abstract 4000.

Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007;25(13):1658-1664.

Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359(11):1116-1127.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment B.

HCPCS Level II Code Number(s)

J9055

Injection, cetuximab, 10 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

2/26/2024

Version Issued Date: