CurrentmhnPolicy CP.PHAR.317

ERBITUX (PDF)

Medical necessity and prior authorization criteria for cetuximab (Erbitux) across Commercial, HIM, and Medicaid lines of business, including initial and continuation approval requirements, approved indications (FDA and selected off-label per NCCN), dosing limits, and approval durations.

Policy Summary

Payermhn

PolicyERBITUX (PDF)

Policy CodePolicy CP.PHAR.317

Change TypeAnnual clinical updates (2023-2025)

Effective Date02.01.17

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria; prior authorization may be required for some combination agents and generic trial may be required for brand requests.

SourceLink

POLICY UPDATE CHANGES

4Q 2025 annual review: added reirradiation with concurrent radiotherapy option for HNSCC; replaced 'unresectable' with 'recurrent' for CRC and clarified POLE/POLD1 ultrahypermutated requirement; removed prior therapy requirement for BRAF V600E when combined with Braftovi and allowed with or without FOLFOX; modified left-sided colon cancer requirement to include unresectable metachronous metastases; simplified NSCLC progression criterion; extended initial approval duration for HIM/Medicaid to 12 months and standardized commercial approval duration.

4Q 2024 annual review: per NCCN added unresectable qualifier and alternative combinations for HNSCC; added KRAS G12C, dMMR/MSI-H, and POLE/POLD1 pathways for CRC.

4Q 2023 annual review: added combination with Opdivo for HNSCC, added CapeOX for CRC, and limited cetuximab use to left-sided tumors for certain metastatic colon cancer cases.

5Primary Indications Covered (HNSCC, CRC, NSCLC, Penile, Skin)

≥18Minimum Age (years)

6/12Approval durations (Commercial/HIM-Medicaid months)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: medical necessity and prior authorization criteria for cetuximab (Erbitux) across Commercial, HIM, and Medicaid lines of business, including initial and continuation approval requirements, approved indications (FDA and selected off-label per NCCN), dosing limits, and approval durations. Primary indications summarized: Cetuximab is an EGFR antagonist with FDA-approved indications for head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC) (including biomarker-defined populations such as KRAS/NRAS/BRAF wild-type and BRAF V600E), and the policy also covers selected off-label indications (non‑small cell lung cancer with sensitizing EGFR mutations, penile cancer, squamous cell skin cancer) per NCCN when criteria are met. Key dosing thresholds: initial weekly dose 400 mg/m2 then 250 mg/m2 weekly or biweekly 500 mg/m2 every 2 weeks; continued therapy cap ≤ 250 mg/m2 weekly or ≤ 500 mg/m2 every 2 weeks. Approval durations: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer. Effective date: 02.01.17. Last review / P&T approval: 11.25.

Initial Therapy Criteria

Other Diagnoses / Initial

Other diagnoses/indications - Initial

If requested use not specifically listed:

ANY of the following

If drug had a recent label change (within last 6 months) not reflected here: follow formulary/no-coverage/non-formulary policies listed (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use not listed in section III and no recent label change applies: refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Continuation Therapy Criteria

Diagnoses / Indications Not Authorized

Provider Actions

Prior Authorization

Prior authorization required with documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) that the member meets all approval criteria. Prior authorization may be required for some combination agents and for brand-name requests may require trial of generic equivalent if available.

Affected code: J9055
Prior authorization may be required for combination agents (e.g., platinum therapies, Gilotrif)
Required documentation types: office chart notes, lab results, or other clinical information

Documentation Required

Genotype/biomarker documentation for CRC

For colorectal cancer indications, providers must document tumor genotype/biomarker status as applicable to support medical necessity.

Applicable Codes

HCPCS - Injection code for cetuximabHCPCSCovered

J9055

Injection, cetuximab, 10 mg

Clinical Evidence and References

Evidence summary: policy references the Erbitux Prescribing Information (FDA) and the NCCN Drugs & Biologics Compendium and disease-specific NCCN guidelines (Head & Neck, NSCLC, Colon, Skin) as cited. The policy incorporates FDA labeling and NCCN compendium/guideline recommendations to authorize selected off-label uses when the policy criteria (e.g., biomarker, prior therapy, regimen, and dosing requirements) are met.

Background

Background: Cetuximab is an epidermal growth factor receptor (EGFR) antagonist. FDA-approved indications include treatment of head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC), including certain biomarker-defined CRC populations (e.g., KRAS/NRAS/BRAF wild-type and BRAF V600E when combined with encorafenib). This policy incorporates FDA labeling and NCCN compendium guidance to authorize selected off-label uses (such as specific NSCLC, penile, and squamous cell skin cancer scenarios) when the policy's clinical criteria are satisfied.

Revision History

2025-11-25Policy revisionLatest

4Q 2025 annual review: added reirradiation with concurrent radiotherapy option for HNSCC; replaced 'unresectable' with 'recurrent' for CRC and specified POLE/POLD1 ultrahypermutated phenotype; removed prior therapy requirement for BRAF V600E when combined with Braftovi and allowed with or without FOLFOX; modified left-sided colon cancer requirement to include unresectable metachronous metastases; simplified NSCLC progression criterion; extended initial approval duration for HIM/Medicaid to 12 months and standardized commercial approval duration.

2024-11-24Policy revision

4Q 2024 annual review: per NCCN added unresectable qualifier and alternative combinations for HNSCC; added KRAS G12C, dMMR/MSI-H, and POLE/POLD1 pathways for CRC.

Policy Summary

Payermhn

PolicyERBITUX (PDF)

Policy CodePolicy CP.PHAR.317

Change TypeAnnual clinical updates (2023-2025)

Effective Date02.01.17

Next Review Date

SourceLink

On This Page

KRAS/NRAS/BRAF (wild-type — no mutations in KRAS, NRAS, or BRAF genes)
BRAF V600E
KRAS G12C
dMMR/MSI-H
POLE/POLD1 with ultrahypermutated phenotype (e.g., tumor mutation burden > 50 mut/Mb)

Billing Rule

Dose support for off-label regimens

If the requested dose or regimen is outside the standard dosing limits or is an off-label regimen, the prescriber must submit supporting evidence (practice guidelines or peer-reviewed literature) to justify the dosing. Reference the cetuximab HCPCS code for billing.

Prescriber must submit evidence for off-label dosing (guidelines or peer-reviewed literature)
Relevant billing code: J9055

Step Therapy

Checkpoint inhibitor requirement for certain CRC and skin cancer subtypes

Certain colorectal cancer biomarker-positive cases and squamous cell skin cancer require prior use of or progression on checkpoint inhibitor immunotherapy before cetuximab may be used in the specified combination regimens.

For dMMR/MSI-H or POLE/POLD1 CRC: member must be ineligible for or have progressed on checkpoint inhibitor immunotherapy before cetuximab is used as specified
For squamous cell skin cancer proposing combination therapy (e.g., with carboplatin and paclitaxel): member must be ineligible for or have progressed on immune checkpoint inhibitors

4Q 2023 annual review: added combination with Opdivo for HNSCC, added CapeOX for CRC, and limited cetuximab use to left-sided tumors for certain metastatic colon cancer cases.