CurrentNeighborhood Health Plan of Rhode IslandPolicy 1892-A

Erbitux

This policy defines coverage, prior authorization documentation, authorization durations, and continuation criteria for Erbitux (cetuximab) across FDA-approved indications and specified compendial uses for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErbitux

Policy CodePolicy 1892-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization required; submit documentation of RAS (KRAS/NRAS) status or KRAS G12C mutation where applicable, BRAF mutation status where applicable, and EGFR expression where applicable to initiate review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

6Covered Indications (listed)

6Authorization Duration (months)

3Required Mutation Tests Mentioned

Coverage Summary & Covered Indications

Erbitux (cetuximab) is an anti-EGFR monoclonal antibody. It has FDA‑approved indications in head and neck cancer (including use with radiation for initial treatment of locally or regionally advanced SCCHN, with platinum/fluorouracil for first‑line recurrent/metastatic SCCHN, and as a single agent after platinum failure) and in certain colorectal cancers (for K‑Ras wild‑type, EGFR‑expressing metastatic colorectal cancer in combination with FOLFIRI for first‑line treatment, with irinotecan for irinotecan‑refractory disease, and as a single agent for patients who have failed oxaliplatin‑ and irinotecan‑based chemotherapy). The policy references the Erbitux package insert and the NCCN Drugs & Biologics Compendium as background references.

General Covered Indications

Erbitux is covered for the following FDA-approved indications and compendial uses when all approval criteria are met and member has no exclusions:

ANY of the following

Head and neck cancer - combination with radiation: In combination with radiation therapy for initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).
Head and neck cancer - first-line with platinum/5-FU: In combination with platinum-based therapy with fluorouracil for first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN.
Head and neck cancer - single agent after platinum failure: As a single agent for treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
mCRC - K-Ras wild-type EGFR-expressing: For K-Ras wild-type, EGFR-expressing metastatic colorectal cancer (mCRC) as determined by an FDA-approved test: in combination with FOLFIRI for first-line treatment; in combination with irinotecan in patients refractory to irinotecan-based chemotherapy; or as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
mCRC - BRAF V600E combination: In combination with encorafenib for treatment of adult patients with metastatic colorectal cancer with BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Compendial uses: colorectal cancer, head and neck cancer, penile cancer, squamous cell skin cancer, non-small cell lung cancer per listed criteria.

Initial Therapy Criteria by Disease State

Colorectal Cancer Coverage Criteria

Authorization of 6 months may be granted when the following are met:

ALL of the following

Indication: unresectable/inoperable, advanced, or metastatic colorectal cancer (including appendiceal adenocarcinoma and anal adenocarcinoma).
Panitumumab clinical failure: Member has not previously experienced clinical failure on panitumumab unless other listed criteria apply.
Genomic/line-specific options
- RAS wild-type requirement: RAS (KRAS and NRAS) mutation status is negative (wild-type).
- BRAF V600E combination: If tumor is positive for BRAF V600E mutation, Erbitux will be used in combination with encorafenib (Braftovi).
- KRAS G12C-specific: Disease is KRAS G12C mutation positive AND requested medication will be used in combination with sotorasib (Lumakras) or adagrasib (Krazati) AND member previously received treatment with chemotherapy.
- First-line left-sided tumor requirement: For first-line treatment of colon cancer, the tumor is left-sided only.

Penile Cancer Coverage Criteria

Authorization of 6 months may be granted when the following is met:

Penile cancer subsequent treatment: Use as a single agent for subsequent treatment of metastatic/recurrent penile cancer.

Squamous Cell Skin Cancer Coverage Criteria

Authorization of 6 months may be granted when any of the following disease states apply:

Squamous cell skin cancer options: Use as a single agent or in combination with carboplatin and paclitaxel for unresectable/inoperable/incompletely resected, locally advanced, regional, recurrent, or distant metastatic squamous cell skin cancer.

Non-Small Cell Lung Cancer (NSCLC) Coverage Criteria

Authorization of 6 months may be granted for subsequent treatment when ALL of the following are met:

NSCLC combination and mutation requirement: Requested medication will be used in combination with afatinib (Gilotrif) AND member has a known sensitizing EGFR mutation (e.g., EGFR exon 19 deletion or L858R mutation, or EGFR S768I, L861Q, and/or G719X mutation) following disease progression on EGFR tyrosine kinase inhibitor therapy.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization and documentation required

Prior authorization required to initiate therapy. Submit documentation of RAS (KRAS and NRAS) status or KRAS G12C mutation where applicable, BRAF mutation status where applicable, and EGFR expression where applicable to initiate prior authorization review.

Prior Authorization

Authorization duration

Initial and continuation authorizations may be granted for up to 6 months for covered indications. Reauthorization requires there be no evidence of unacceptable toxicity or disease progression while on the current regimen.

Denial Risk

Denial if mutation results incompatible

Claims for colorectal cancer may be denied/not authorized if a RAS mutation is present or if Ras mutation test results are unknown.

Documentation Required for Prior Authorization

Submission requirements to initiate prior authorization review:

Required documentation: Documentation of RAS wild-type status or KRAS G12C mutation, where applicable; documentation of BRAF mutation status, where applicable; documentation of EGFR expression, where applicable.

Background & Evidence References

Key background references cited by the policy include the Erbitux package insert and the NCCN Drugs & Biologics Compendium. The package insert provides the FDA‑approved indications for head and neck cancer and colorectal cancer. The NCCN compendia and guidelines are cited for supported compendial uses (colorectal cancer, head and neck cancer, penile cancer, squamous cell skin cancer, and non‑small cell lung cancer) and for clinical guidance referenced in the policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErbitux

Policy CodePolicy 1892-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Erbitux

Coverage Summary & Covered Indications

Initial Therapy Criteria by Disease State

Continuation / Reauthorization Criteria

Limitations, Exclusions, & Not Covered Uses

Prior Authorization & Documentation Requirements

Drugs Referenced / Coding

Definitions

Background & Evidence References

Revision History

Erbitux	cetuximab (brand)
cetuximab	generic name