ModifiedmhnPolicy CP.PHAR.321

Panitumumab (Vectibix)

Defines medical necessity and coverage criteria for panitumumab (Vectibix) in adults with metastatic or advanced colorectal cancer and other cited indications; applies to providers submitting prior authorization for members under the payer's lines of business.

Policy Summary

Payermhn

PolicyPanitumumab (Vectibix) — coverage criteria for metastatic/advanced colorectal cancer

Policy CodePolicy CP.PHAR.321

Change TypeMaterial: new KRAS G12C indicationrevisions to biomarker, therapy, and authorization durations

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, biomarker results, prior therapies, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Added new FDA-approved indication of KRAS G12C-mutated CRC.

Specified that POLE/POLD1 mutation positive disease must have ultra-hypermutated phenotype.

Removed prior therapy requirement when prescribed for BRAF V600E mutation positive in combination with Braftovi.

Modified requirement for left-sided colon cancer to apply only to unresectable synchronous and metachronous disease (liver and/or lung) in specified contexts.

Extended initial approval duration for HIM/Medicaid from 6 to 12 months and adjusted Commercial authorization durations to standard injectable authorizations (Commercial: 6 months or to the member's renewal date).

Added that combination treatment with Vectibix and Braftovi is for advanced or metastatic disease.

6 mg/kg q14dDosing

12 moHIM/Medicaid approval

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Coverage Criteria for Panitumumab (Vectibix)

inv-01: Initial Therapy — Covered when ALL of the following are met for colorectal cancer

Covered when ALL of the following are met for colorectal cancer:

Initial Approval — Colorectal Cancer: 1. Diagnosis of advanced, recurrent, or metastatic colorectal cancer (CRC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease meets ONE of the following biomarker criteria: (a) KRAS/NRAS/BRAF wild-type (no mutations in KRAS, NRAS, or BRAF), (b) BRAF V600E mutation positive, (c) KRAS G12C mutation positive, (d) dMMR/MSI-H, or (e) POLE/POLD1 mutation positive with an ultrahypermutated phenotype (e.g., TMB > 50 mut/Mb); 5. Prescribed regimen is ONE of the following: (a) single agent, (b) in combination with FOLFOX, CapeOX, or FOLFIRI, (c) in combination with irinotecan following prior therapy, (d) if BRAF V600E mutation positive: in combination with Braftovi with or without FOLFOX, or (e) if KRAS G12C mutation positive: in combination with Lumakras or Krazati following prior therapy; 6. For colon cancer that is KRAS/NRAS/BRAF wild-type with unresectable synchronous or metachronous liver and/or lung metastases: tumor is left-sided only (see Appendix D); 7. For dMMR/MSI-H or POLE/POLD1 mutation positive tumors: member is ineligible for or has progressed on checkpoint inhibitor immunotherapy; 8. Dose does not exceed 6 mg/kg every 14 days OR dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 9. Prescribed regimen is FDA‑approved or recommended by NCCN.

Multiple nested biomarker and regimen conditions required.

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Continued Therapy — Colorectal Cancer: 1. Member is currently receiving Vectibix via the Centene benefit or documentation supports current receipt of Vectibix for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed 6 mg/kg every 14 days OR the new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 4. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued approvals require evidence of clinical benefit and adherence to dosing limits or guideline-supported justification.

inv-03: Biomarker and disease-site coverage pathways — Covered when meeting NCCN/FDA biomarker and disease-site criteria as specified

Covered when meeting NCCN/FDA biomarker and disease-site criteria as specified below

Biomarker-driven indications: Includes KRAS/NRAS/BRAF wild-type tumors; BRAF V600E mutation positive (may be given with Braftovi, with or without FOLFOX); KRAS G12C‑mutated CRC (new FDA indication); dMMR/MSI‑H; and POLE/POLD1 mutation positive with ultra‑hypermutated phenotype.see biomarker status

Specific prior therapy requirements vary by pathway; some prior therapy requirements removed for certain biomarker combinations.

Disease extent qualifiers: CRC must be advanced, recurrent, or metastatic for many pathways; left‑sided colon cancer requirement applies only to unresectable synchronous and metachronous metastases (liver and/or lung) in KRAS/NRAS/BRAF wild‑type contexts as specified.advanced/recurrent/metastatic

See full policy for line‑of‑therapy and regimen‑specific requirements.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient off‑label documentation demonstrating efficacy and safety. For commercial members, reference the off‑label use policy CP.CPA.09; for Medicaid, reference CP.PMN.53; and for Health Insurance Marketplace lines of business, reference HIM.PA.154 (or other applicable evidence of coverage documents) when submitting supporting evidence.

The inclusion or exclusion of procedure or billing codes in this policy does not guarantee coverage. Codes are provided for informational purposes only; providers must follow current professional coding guidance and the member’s benefit terms when submitting claims.

Use of panitumumab in patients with RAS‑mutant metastatic colorectal cancer is not indicated except when given in combination with sotorasib for patients with KRAS G12C‑mutated mCRC per the FDA‑approved indication. Panitumumab is also not indicated when RAS mutation status is unknown; documentation of biomarker testing is required to determine eligibility.

Coding references within this policy are provided for informational purposes and do not, by themselves, authorize coverage. Authorization decisions are based on the clinical criteria in the policy, documented clinical information, and the member’s benefit coverage.

Coding and Dosing Information

HCPCS CodesHCPCS

J9303

Injection, panitumumab, 10 mg

Referenced HCPCS for panitumumabHCPCS

J9303

Injection, panitumumab, 10 mg

inv-10: Dose limit — Dose does not exceed 6 mg/kg every 14 days

Dose limitDose does not exceed 6 mg/kg every 14 days

Alternate dosing supportDose above 6 mg/kg q14 days allowed if supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

Standard regimen referenceStandard dosing regimen listed as 6 mg/kg every 14 days for RAS wild-type CRC (see dosing section)

inv-11: Initial approval duration (HIM/Medicaid) — 12 months

Initial approval duration (HIM/Medicaid)12 months

Change noteExtended initial approval duration for HIM/Medicaid from 6 to 12 months per coding implications

Provider Responsibilities and Authorization Process

Billing Rule

Coding does not guarantee coverage

Coding referenced in this policy is provided for informational purposes only. Inclusion or exclusion of any codes (for example, HCPCS J9303) does not guarantee coverage. Providers must reference current professional coding guidance and payer billing rules prior to claim submission.

Codes are illustrative — verify up-to-date coding guidance before claim submission.
Inclusion/exclusion of codes does not ensure coverage.

Documentation Required

Clinical documentation required

Provider must submit documentation (such as office chart notes, diagnostic test results, pathology reports, biomarker testing, prior treatment records, and relevant laboratory data) that supports the member meets all approval criteria. Documentation should clearly support diagnosis, biomarker status, prior therapies, treatment intent, dosing rationale for off-label use, and clinical response when applicable.

Background on Panitumumab

Panitumumab (Vectibix) is a monoclonal antibody that acts as an EGFR antagonist. It is FDA‑approved for treatment of adult patients with wild‑type RAS metastatic colorectal cancer — in combination with FOLFOX for first‑line treatment and as monotherapy after progression on fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑containing chemotherapy. Additionally, panitumumab is FDA‑approved in combination with sotorasib for adults with KRAS G12C‑mutated mCRC following prior chemotherapy. The standard dosing regimen is 6 mg/kg IV every 14 days as described in the prescribing information.

Definitions and Abbreviations

inv-22: dMMR/MSI-H — deficient mismatch repair / microsatellite instability-high

DefinitiondMMR/MSI-H = deficient mismatch repair / microsatellite instability-high

Policy contextEligible when member is ineligible for or has progressed on checkpoint inhibitor immunotherapy for colorectal cancer

Abbreviation sourceListed in Appendix A (Abbreviation/Acronym Key)

inv-23: FOLFOX — fluorouracil, leucovorin, oxaliplatin

DefinitionFOLFOX = fluorouracil, leucovorin, oxaliplatin

Use in policyPanitumumab may be given in combination with FOLFOX for first-line treatment of wild-type RAS mCRC

Line of Therapy Specifications

inv-25: first-line | second-line — 1 top-level node

Line of therapy options: First‑line: in combination with FOLFOX; Second‑line (or subsequent): monotherapy following progression after fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑containing chemotherapy; combination with sotorasib for KRAS G12C‑mutated mCRC after prior chemotherapy.

Line‑of‑therapy selection varies by biomarker and regimen per FDA and NCCN indications.

inv-26: first-line | second-line (varies by biomarker/regimen) — 1 top-level node

Line of therapy specifics: Policy simplifies or varies first‑line/second‑line qualifiers by biomarker and regimen: prior therapy requirements have been modified or removed in certain biomarker contexts (e.g., BRAF V600E with Braftovi, KRAS G12C FDA approval) and combinations per NCCN/NCH guidance.see full policy

Refer to regimen‑specific criteria for application to individual patients.

Biomarker Testing and Required Status

inv-27: KRAS/NRAS — wild-type in both KRAS and NRAS as determined by an FDA-approved test

KRAS/NRAS status requiredWild-type in both KRAS and NRAS as determined by an FDA-approved test

Clinical roleDetermines eligibility for standard Vectibix indication in metastatic colorectal cancer

SourceFDA approved indication language and initial approval criteria

inv-28: BRAF V600E — biomarker entry (see policy for context and combinations)

BRAF V600E biomarkerBRAF V600E mutation positive is an included disease criterion allowing administration of Vectibix; may be given in combination with Braftovi with or without FOLFOX per NCCN

Prior therapyPrior therapy requirement removed when prescribed in combination with Braftovi per recent revisions

Covered Regimens and Regimen-specific Conditions

Regimen	Indication / Key criteria	Coverage status
Panitumumab in combination with FOLFOX	First-line treatment for metastatic colorectal cancer (RAS wild-type: wild-type in both KRAS and NRAS as determined by an FDA‑approved test). Dose per policy: 6 mg/kg IV every 14 days (maximum 6 mg/kg).	Covered

Regimen	Indication / Key criteria	Coverage status
Panitumumab monotherapy	Monotherapy after disease progression following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy (per FDA indication). Dose limit: does not exceed 6 mg/kg every 14 days unless supported by guidelines/literature with documentation.	Covered

Regimen	Indication / Key criteria	Coverage status
Panitumumab in combination with sotorasib	For adult patients with KRAS G12C‑mutated metastatic colorectal cancer as determined by an FDA‑approved test who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. Dose regimen: panitumumab 6 mg/kg IV every 14 days in combination with sotorasib per FDA‑approved dosing; maximum panitumumab dose 6 mg/kg.	Covered

Regimen	Indication / Key criteria	Coverage status
Panitumumab in combination with Braftovi with or without FOLFOX	For BRAF V600E mutation‑positive advanced, recurrent, or metastatic colorectal cancer. Policy allows panitumumab combined with Braftovi ± FOLFOX per NCCN‑recommended regimens; prior therapy requirements removed for this biomarker context as specified in the policy. Dose considerations: panitumumab dosing up to 6 mg/kg every 14 days unless guideline-supported off‑label dosing is provided.	Covered

Regimen	Indication / Key criteria	Coverage status
Vectibix (panitumumab) alone or with chemotherapy or targeted combinations	Single‑agent panitumumab or in combination with regimens such as irinotecan, FOLFOX, CapeOx, or targeted combinations (e.g., with Braftovi for BRAF V600E) per NCCN recommendations. Indications include advanced, recurrent, or metastatic CRC with appropriate biomarker context (e.g., wild‑type RAS, BRAF V600E) and other NCCN/FDA‑specified pathways. Dose per policy: 6 mg/kg IV every 14 days (maximum 6 mg/kg) unless guideline/literature justification provided.	Covered (with criteria)