CurrentCentenePolicy CP PHAR.317

Cetuximab (Erbitux) coverage criteria

Defines medical necessity, prior authorization requirements, indications (FDA and selected off-label per NCCN) and continuation criteria for cetuximab (Erbitux) for Commercial, HIM, and Medicaid lines of business administered by Centene.

Policy Summary

PayerCentene

PolicyCetuximab (Erbitux) coverage criteria

Policy CodePolicy CP PHAR.317

Change TypeNo material change

Effective DateFeb 1, 2017

Next Review Date

Key ActionSubmit clinical documentation including office notes, lab and biomarker test results, prior therapy history, and supporting evidence for off-label uses to demonstrate the member meets indication-specific criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsTypical initial approval duration (selected off-label indications)

12 monthsContinued therapy approval duration

J9055HCPCS code for cetuximab (10 mg)

Medically Necessary Criteria for Cetuximab (Erbitux)

General requirements (applies to all indications)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ALL of the following

Provider must submit documentation (office notes, lab results, other clinical information) supporting that member has met all approval criteria.
Prescribed by or in consultation with an oncologist.
Patient age is ≥ 18 years.
Prescribed regimen must be FDA-approved or recommended by NCCN; for off-label uses, prescriber must submit supporting evidence from practice guidelines or peer-reviewed literature.
Dose must be within FDA maximum limits for any FDA-approved indication, or within limits supported by practice guidelines/peer-reviewed literature for off-label use.

Initial approval — Head and Neck Squamous Cell Carcinoma (HNSCC)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of HNSCC (see Appendix D for anatomic subtypes).
Disease is advanced, recurrent, unresectable, or metastatic.
Prescribed by or in consultation with an oncologist.
Prescribed in one of the following ways
- In combination with platinum-based therapy with fluorouracil (5-FU) for first-line treatment (or other platinum-based combos per policy).
- In combination with radiation therapy for locally or regionally advanced disease.
- As a single agent for recurrent or metastatic disease progressing after platinum-based therapy.
- In combination with Opdivo (nivolumab), Keytruda (pembrolizumab), paclitaxel, or docetaxel where appropriate (e.g., cisplatin-ineligible).
Dose limits (one of)
- Biweekly dosing: dose does not exceed 500 mg every 2 weeks.≤ 500 mg every 2 weeks
- Weekly dosing: initial dose 400 mg/m2 followed by 250 mg/m2 weekly.initial 400 mg/m2 then 250 mg/m2 weekly

Initial approval — Colorectal Cancer (CRC)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of advanced, unresectable, or metastatic colorectal cancer.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Molecular/biomarker requirements (one of)
- K-Ras wild-type, EGFR-expressing metastatic CRC as determined by an FDA-approved test.
- KRAS G12C mutation positive.
- BRAF V600E mutation positive.
- Deficient mismatch repair / microsatellite instability-high (dMMR/MSI-H).
- POLE/POLD1 mutation positive.
Permitted regimens (one of)
- As a single agent.
- In combination with FOLFIRI, FOLFOX, or CapeOX.
- In combination with irinotecan following prior therapy (limited to after therapy use).
- If BRAF V600E mutation positive: in combination with encorafenib (Braftovi) following prior therapy.
Dose limits (one of)
- Biweekly dosing: dose does not exceed 500 mg every 2 weeks.≤ 500 mg every 2 weeks
- Weekly dosing: initial dose 400 mg/m2 followed by 250 mg/m2 weekly.initial 400 mg/m2 then 250 mg/m2 weekly
- Dose supported by practice guidelines or peer-reviewed literature for the off-label use (prescriber must submit evidence).
For dMMR/MSI-H or POLE/POLD1 mutation positive cancers: member is ineligible for or has progressed on checkpoint inhibitor immunotherapy.
For colon cancer that is KRAS/NRAS/BRAF wild-type with unresectable synchronous liver and/or lung metastases: tumor must be left-sided only (see Appendix E).

Initial approval — Non-Small Cell Lung Cancer (NSCLC) (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Tumor mutation requirement (one of)
- Tumor is EGFR exon 19 deletion or exon 21 L858R, EGFR S768I, L861Q, and/or G719X mutation positive (sensitizing EGFR mutations).
- Tumor is T790M positive and disease has progressed on or after Tagrisso (osimertinib).
Permitted regimens (one of)
- Prescribed in combination with afatinib (Gilotrif) as subsequent therapy after progression on EGFR TKI; prior authorization may be required.
- Combination options per NCCN and supported literature.
Dose within FDA maximum limit for any FDA-approved indication or supported by practice guidelines/peer-reviewed literature for the off-label use (prescriber evidence required).
Approval duration: 6 months.

Initial approval — Penile Cancer (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of metastatic or recurrent penile cancer.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Prescribed as subsequent-line systemic therapy.
Prescribed as a single agent.
Dose is within FDA maximum limit for any FDA-approved indication or supported by practice guidelines/peer-reviewed literature (prescriber must submit evidence).
Prescribed regimen must be FDA-approved or recommended by NCCN.
Approval duration: 6 months.

Initial approval — Squamous Cell Skin Cancer (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of squamous cell skin cancer.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Permitted regimens (one of)
- As a single agent.
- If member is ineligible for or progressed on immune checkpoint inhibitors and clinical trials: in combination with carboplatin and paclitaxel.
Disease is advanced, unresectable, high-risk, recurrent, metastatic, inoperable, or not fully resectable.
Dose is within FDA maximum limit or supported by practice guidelines/peer-reviewed literature (prescriber must submit evidence).
Approval duration: 6 months.

Other diagnoses/indications (non-formulary / off-label)

Covered when ONE of the following applies:

ANY of the following

Use is addressed by the no coverage criteria policy or non-formulary policy for the relevant line of business.
See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If the requested use is not specifically listed and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business.
See CP.CPA.09, HIM.PA.154, CP.PMN.53

Continued therapy (renewal) criteria

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving cetuximab via Centene benefit or documentation supports member has received cetuximab for a covered indication for at least 30 days.
Member is responding positively to therapy.
If request is for a dose increase (one of)
- For HNSCC or CRC: new dose does not exceed 250 mg weekly or 500 mg every 2 weeks.≤ 250 mg weekly or ≤ 500 mg every 2 weeks
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Approval duration for continued therapy: 12 months.

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization required with documentation

Submit a prior authorization request with supporting clinical documentation (office notes, laboratory results, biomarker test reports, and prior therapy history) showing the member meets the indication-specific criteria and dosing limits. Prior authorization may also be required when cetuximab is prescribed concurrently with certain agents (e.g., platinum-based therapies, Gilotrif/afatinib, Tagrisso/osimertinib).

J9055

Documentation Required

Biomarker and prior therapy documentation

For the colorectal cancer and NSCLC pathways, include mutation testing results and documentation of prior therapies or disease progression when applicable (e.g., KRAS/NRAS/BRAF status, EGFR exon mutations including sensitizing EGFR mutations, dMMR/MSI-H, POLE/POLD1, and evidence of progression after prior therapies such as platinum-based or checkpoint inhibitor therapy).

Documentation Required

Off-label evidence submission

When requesting cetuximab for off-label indications or dosing outside FDA labeling that are supported by practice guidelines, the prescriber must submit the supporting practice guideline citation or peer-reviewed literature evidence to justify the use and dose.

Denial Risk

Denial for unsupported off-label use

Requests for non–FDA approved indications that are not addressed in this policy, or that lack sufficient documentation of efficacy and safety per the off-label use policies, may be denied.

Clinical Context

Cetuximab (Erbitux) is an epidermal growth factor receptor (EGFR) antagonist approved for certain head and neck squamous cell carcinomas (HNSCC) and for selected indications in colorectal cancer (CRC). FDA‑labeled HNSCC uses include first‑line treatment of recurrent locoregional or metastatic disease in combination with platinum‑based therapy and fluorouracil (5‑FU), concurrent use with radiation for locally or regionally advanced disease, and single‑agent therapy for recurrent/metastatic disease after platinum therapy. For CRC, cetuximab is indicated in K‑Ras wild‑type, EGFR‑expressing metastatic CRC and in combination regimens (e.g., with FOLFIRI) or as single agent in later lines; the label also supports use with encorafenib for BRAF V600E‑mutant metastatic CRC following prior therapy.

Molecular biomarkers significantly influence appropriateness of cetuximab. The policy requires testing and documentation of relevant mutations or biomarkers for certain pathways — for CRC this includes KRAS/NRAS and BRAF status and EGFR expression, and special pathways address BRAF V600E, KRAS G12C, dMMR/MSI‑H, and POLE/POLD1 alterations. For NSCLC off‑label use, specified sensitizing EGFR mutations (e.g., exon 19 deletions, exon 21 L858R, S768I, L861Q, G719X) and T790M status guide eligibility and sequencing with EGFR tyrosine kinase inhibitors.

Centene’s policy incorporates FDA‑approved indications and NCCN‑supported or other off‑label uses (e.g., certain NSCLC, penile cancer, and squamous cell skin cancer pathways) when supported by guideline or peer‑reviewed evidence. Off‑label requests must be supported by practice guidelines or literature and prescriber documentation; for some biomarker‑defined groups (for example dMMR/MSI‑H or POLE/POLD1 in CRC) patients must be ineligible for or have progressed on checkpoint inhibitor therapy prior to approval.

Dosing options in the policy reflect prescribing information and guideline updates: a weekly schedule (initial 400 mg/m2 then 250 mg/m2 weekly) and a biweekly option (≤ 500 mg every 2 weeks). Continued therapy criteria limit allowed dose increases for HNSCC and CRC to no more than 250 mg weekly or 500 mg every 2 weeks unless higher dosing is supported by guidelines or literature and documented by the prescriber.

Policy Summary

PayerCentene

PolicyCetuximab (Erbitux) coverage criteria

Policy CodePolicy CP PHAR.317

Change TypeNo material change

Effective DateFeb 1, 2017

Next Review Date

SourceLink

On This Page

OpenPayer

Cetuximab (Erbitux) coverage criteria

Medically Necessary Criteria for Cetuximab (Erbitux)

Relevant Billing Codes

Authorization, Documentation, and Denial Risks

Clinical Context

Terms and Abbreviations

At-a-Glance Policy Durations and Codes

Cetuximab (Erbitux) coverage criteria

Medically Necessary Criteria for Cetuximab (Erbitux)

Relevant Billing Codes

Authorization, Documentation, and Denial Risks

Clinical Context

Terms and Abbreviations

Additional Policies to Review

At-a-Glance Policy Durations and Codes