CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Erbitux (cetuximab) — Coverage Criteria

Governs prior authorization, coverage criteria, and continuation for Erbitux (cetuximab) for FDA‑approved and compendial oncology indications for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErbitux (cetuximab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation of RAS (KRAS/NRAS) status, BRAF and EGFR results when applicable; approvals are typically for 6 months if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical authorization period

FDA + compendialcovered indications

RAS/BRAF requiredmolecular documentation

Allowedreauthorization

Coverage Criteria for Erbitux (cetuximab)

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Path A: Member meets ALL of the following: (i) RAS (KRAS and NRAS) mutation status is negative (wild-type); (ii) if tumor is BRAF V600E mutation positive, cetuximab will be used in combination with encorafenib (Braftovi); (iii) for colon cancer, the tumor is left‑sided only.

Authorization of 6 months may be granted when criteria are met and member has not previously experienced clinical failure on panitumumab.

Path B: Member meets ALL of the following: (i) disease is KRAS G12C mutation positive; (ii) cetuximab will be used in combination with sotorasib (Lumakras) or adagrasib (Krazati); (iii) member previously received treatment with chemotherapy.

Authorization of 6 months may be granted when criteria are met and member has not previously experienced clinical failure on panitumumab.

Squamous Cell Carcinoma of the Head and Neck

Covered for squamous cell carcinoma of the head and neck when ANY of the following are met:

H&N Criteria: Any of the following: (1) disease is locally or regionally advanced, unresectable, recurrent, persistent, or metastatic; (2) member is unfit for surgery; (3) the requested medication will be used in combination with radiation.

Authorization of 6 months may be granted.

Squamous Cell Skin Cancer

Covered for squamous cell skin cancer when ALL of the following apply:

SCC Skin: Used as a single agent for unresectable, inoperable, incompletely resected, locally advanced, regional, recurrent, or distant metastatic squamous cell skin cancer.

Authorization of 6 months may be granted.

Non-Small Cell Lung Cancer (subsequent therapy)

Covered for non-small cell lung cancer (subsequent therapy) when ALL of the following are met:

NSCLC Criteria: Member meets ALL of the following: (1) cetuximab will be used in combination with afatinib (Gilotrif); (2) member has a known sensitizing EGFR mutation (e.g., exon 19 deletion, L858R, or EGFR S768I, L861Q, G719X) following disease progression on EGFR tyrosine kinase inhibitor therapy.

Authorization of 6 months may be granted for subsequent treatment.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Typical approvals are for 6 months for covered indications (see clinical criteria).

Prior authorization required
Typical approval duration: 6 months

Denial Risk

Experimental / Investigational Exclusion

Requests for indications not explicitly listed in the coverage criteria (Section III) are considered experimental/investigational and are not medically necessary; such requests will be denied.

Documentation Required

Required Molecular and Biomarker Documentation

Submit documentation of tumor molecular and biomarker testing to support medical necessity decisions. Provide the specific test results and reports.

RAS (KRAS and NRAS) wild-type status (required for most colorectal indications)
KRAS G12C mutation status when applicable
BRAF V600E mutation status when applicable (and if positive, note planned combination with encorafenib)
EGFR mutation/expression status when applicable

Documentation Required

Panitumumab Consideration

When the request is for colorectal cancer, note that authorization may require the member has not previously experienced clinical failure on panitumumab when applicable; ensure documentation of prior anti-EGFR therapies and response history is included.

Document prior exposure and clinical failure (or lack thereof) to panitumumab where applicable
If tumor is BRAF V600E positive, document plan to use encorafenib in combination
For KRAS G12C positive disease, document planned combination with sotorasib or adagrasib and prior chemotherapy

Regimens and Combination Therapies

Regimen	Indication	Coverage
Erbitux (cetuximab) + encorafenib (Braftovi)	BRAF V600E mutation–positive metastatic colorectal cancer after prior therapy	Covered when policy criteria are met (see colorectal cancer criteria: RAS wild-type path and BRAF V600E positive used with encorafenib); authorization typically 6 months

Regimen	Indication	Coverage
Erbitux (cetuximab) + sotorasib (Lumakras) or adagrasib (Krazati)	KRAS G12C–positive colorectal cancer in patients previously treated with chemotherapy	Covered when policy criteria are met (KRAS G12C positive disease, used in combination with sotorasib or adagrasib, and prior chemotherapy); authorization typically 6 months; member must not have had clinical failure on panitumumab as specified

Regimen	Indication	Coverage
Erbitux (cetuximab) + afatinib (Gilotrif)	Non–small cell lung cancer (recurrent, advanced, or metastatic) with a known sensitizing EGFR mutation following progression on EGFR tyrosine kinase inhibitor therapy	Covered when policy criteria are met (used in combination with afatinib for members with a sensitizing EGFR mutation after EGFR TKI progression); authorization typically 6 months

Required Biomarker and Molecular Documentation

inv-19: RAS (KRAS and NRAS) — negative (wild-type) required

Required statusRAS (KRAS and NRAS) mutation status must be negative (wild-type)

When requiredRequired for colorectal cancer coverage decisions (initial therapy path A)

DocumentationSubmit documentation of RAS wild-type status by an FDA-approved or validated test to initiate prior authorization

Clinical implicationErbitux is not indicated for Ras-mutant colorectal cancer; wild-type required for use

inv-20: KRAS G12C — positive

Required mutationKRAS G12C mutation positive

Indication contextAlternative colorectal cancer pathway (Path B) when disease is KRAS G12C positive

Combination therapyCetuximab will be used in combination with sotorasib (Lumakras) or adagrasib (Krazati)

DocumentationSubmit documentation of KRAS G12C mutation status when applicable

inv-21: BRAF V600E — V600E mutation positive

Required mutationBRAF V600E mutation positive

Indication contextUsed in metastatic colorectal cancer with BRAF V600E mutation after prior therapy in combination with encorafenib

DocumentationSubmit documentation of BRAF mutation status when applicable

inv-22: EGFR expression — biomarker entry

BiomarkerEGFR expression required where applicable (e.g., K-Ras wild-type, EGFR-expressing mCRC)

Indication contextEGFR expression is part of FDA indication for K-Ras wild-type metastatic colorectal cancer

DocumentationSubmit documentation of EGFR expression when applicable to initiate prior authorization

Line of Therapy Designations

first-line

First‑line use:

First‑line CRC (example): Use in combination with FOLFIRI for first‑line treatment of K‑RAS (KRAS) wild‑type, EGFR‑expressing metastatic colorectal cancer as per FDA indication.

Authorization typically granted for 6 months when criteria are met.

second-line

Second‑line use:

Second‑line CRC/Other: Use as single agent or in combination for patients refractory to irinotecan‑based chemotherapy or who have failed oxaliplatin/irinotecan regimens; includes use in BRAF V600E mutated CRC in combination with encorafenib after prior therapy.

Authorization typically granted for 6 months when criteria are met.

salvage

Salvage use:

Salvage (NSCLC): Use in combination with afatinib for members with known sensitizing EGFR mutations following progression on EGFR TKI therapy (subsequent/salvage setting).

Authorization typically granted for 6 months when criteria are met.

Key Definitions

inv-15: RAS wild-type — definition: absence of activating mutations in KRAS and NRAS

DefinitionRAS wild-type: absence of activating mutations in KRAS and NRAS genes as documented by an FDA-approved or validated test

Role in coverageRequired for certain colorectal cancer indications and determines eligibility for Erbitux therapy

Documentation requirementSubmission of RAS wild-type status is necessary to initiate prior authorization review

Erbitux (cetuximab) is a monoclonal antibody directed against the epidermal growth factor receptor (EGFR). It has FDA‑approved indications for certain squamous cell carcinomas of the head and neck and for EGFR‑expressing, KRAS wild‑type metastatic colorectal cancer, and it is used in specified combination regimens for molecularly defined colorectal cancer populations. Documentation of relevant molecular biomarkers (for example, RAS/KRAS/NRAS and BRAF mutation status) is required where noted in the coverage criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErbitux (cetuximab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation of RAS (KRAS/NRAS) status, BRAF and EGFR results when applicable; approvals are typically for 6 months if criteria are met.

SourceLink

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