Medical Policy

Effective Date:12/02/2009 Title:Erbitux (Cetuximab)
Revision Date:01/01/2024 Document:BI256:00
CPT Code(s):J9055
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Erbitux (Cetuximab) requires preauthorization.

2)    Erbitux is an intravenous medication used to treat advanced head and neck cancers, or colorectal cancer, non-small cell lung cancer (NSCLC), penile cancer, and squamous cell skin cancer.

3)    It has been shown that individuals with a certain gene mutation in colon cancers do not respond to Erbitux.

Medical Statement

1)    Erbitux (Cetuximab) is eligible for coverage if meeting the following criteria:

a)    Head and Neck Squamous Cell Cancer

i)     Diagnosis of HNSCC;

ii)    Prescribed by or in consultation with an oncologist;

iii)   Age > 18 years;

iv)   Disease is advanced, recurrent, or metastatic;

v)    Prescribed as one of the following:

(1)  As a single agent;

(2)  In combination with platinum-based therapy (e.g. cisplatin or carboplatin);

vi) Dosing consistent with FDA labeling or NCCN.

b)    Non small cell lung cancer (off label)

i)     Diagnosis of recurrent, advanced, or metastatic NSCLC;

ii)    Prescribed by or in consultation with an oncologist;

iii)   Age > 18 years;

iv)   Tumor is positive for a sensitizing EGFR mutation;

v)    Prescribed in combination with Gilotrif as subsequent therapy;

vi)   One of the following:

(1)  Disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy (e.g. Tarceva, Gilotrif, or Iressa);

(2)  Tumor is T790M positive and disease has progressed on or after Tagrisso;

vii) Dosing is consistent with FDA labeling or NCCN.

 

c)    Colorectal Cancer

i)     Diagnosis of CRC;

ii)    Prescribed by or in consultation with an oncologist;

iii)   Age > 18 years;

iv)   Disease is one of the following:

(1)  Wild-type RAS (defined as wild-type in both KRAS and NRAS);

(2)  BRAF wild-type;

(3)  BRAF V600E mutation positive;

v)    Member has advanced, unresectable or metastatic CRC and one of the following:

(1)  Request is for use as a single agent or in combination with FOLFIRI, FOLFOX, or irinotecan in the initial or subsequent line setting;

(2)  Prescribed in combination with Braftovi if BRAF V600E mutation positive after prior therapy;

vi)   Dosing is consistent with FDA labeling or NCCN.

d)    Penile Cancer (off label)

i)     Diagnosis of metastatic penile cancer;

ii)    Prescribed by or in consultation with an oncologist;

iii)   Age > 18 years;

iv)   Requests is for use as a single agent as subsequent-line systemic therapy;

v)    Dosing is consistent with FDA labeling or NCCN

e)    Squamous Cell Skin Cancer (off label)

i)     Diagnosis of squamous cell skin cancer;

ii)    Prescribed by or in consultation with an oncologist;

iii)   Age > 18 years;

iv)   Request is for use as a single agent;

v)    Disease is locally advanced, high-risk, very high-risk, metastatic, inoperable or not fully resectable;

vi)   Dosing is consistent with FDA labeling or NCCN.

 

Approval Duration: 6 months

  

 

Codes Used In This BI:

 

J9055 - Cetuximab injection

Limits
Intentially left empty
Reference

1. Erbitux Prescribing Information. Indianapolis, IN: Eli Lilly and Company; September 2021. Available at: http://uspl.lilly.com/erbitux/erbitux.html. Accessed August 11, 2022.

2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed August 11, 2022.

3. National Comprehensive Cancer Network. Head and Neck Cancer Version 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf. Accessed August 11, 2022.

4. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 11, 2022.

5. National Comprehensive Cancer Network. Squamous Cell Skin Cancer 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. August 11, 2022.

 

 

EOC Statement:

Supported under genetic testing.

Addendum:

Effective 01/01/2024: Updated criteria for Head and Neck CA, NSCLC, and colorectal cancer; added criteria for penile CA and squamous cell skin cancer.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.