ModifiedCentenePolicy CP.PHAR.321

Panitumumab (Vectibix) coverage

Defines medical necessity criteria, dosing, and authorization requirements for panitumumab (Vectibix) for members under Centene lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage for Vectibix.

Policy Summary

PayerCentene

PolicyPanitumumab (Vectibix) coverage

Policy CodePolicy CP.PHAR.321

Change TypeCriteria and pathway updates (mutation-specific additions and approval duration adjustments)

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with clinical documentation (office notes, labs, biomarker results) demonstrating the member meets the specific initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

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

Added BRAF V600E mutation positive criterion option to wild-type options and simplified prior/combination therapy requirements per NCCN.

Added pathways for KRAS G12C, dMMR/MSI-H, and POLE/POLD1 mutations with corresponding requirements and removed prior therapy requirement when requested as single agent.

Specified that POLE/POLD1 mutation positive disease must have ultra-hypermutated phenotype and added FDA indication for KRAS G12C-mutated CRC; clarified combination use with Braftovi +/- FOLFOX for BRAF V600E.

6 mg/kgstandard maximum dose every 14 days

Adults ≥18minimum age for coverage

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Coverage Criteria

inv-01: Initial Therapy - Colorectal Cancer

Covered when ALL of the following are met

Initial approval - colorectal cancer: 1. Diagnosis of advanced, recurrent, or metastatic colorectal cancer (CRC). 2. Prescribed by or in consultation with an oncologist. 3. Patient age ≥ 18 years. 4. Tumor meets one of the following molecular statuses: a) KRAS/NRAS/BRAF wild-type (no mutations in KRAS, NRAS, or BRAF); b) BRAF V600E mutation positive; c) KRAS G12C mutation positive; d) deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H); e) POLE/POLD1 mutation positive with ultrahypermutated phenotype (e.g., tumor mutation burden > 50 mut/Mb). 5. Prescribed regimen is ONE of the following: a) single-agent panitumumab; b) panitumumab in combination with FOLFOX, CapeOX, or FOLFIRI; c) panitumumab in combination with irinotecan following prior therapy; d) if BRAF V600E mutation positive: panitumumab in combination with Braftovi with or without FOLFOX; e) if KRAS G12C mutation positive: panitumumab 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 disease: member is ineligible for or has progressed on checkpoint inhibitor immunotherapy (see Appendix B). 8. Requested dose meets ONE of the following: a) does not exceed 6 mg/kg every 14 days; or b) 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.

Items correspond to numbered criteria in policy I.A.

inv-02: Continuation Therapy - Colorectal Cancer

Covered when ALL of the following are met

Continued therapy - colorectal cancer: 1. Member is currently receiving panitumumab via the Centene benefit or documentation supports that the member has received panitumumab for at least 30 days for a covered indication. 2. Member is responding positively to therapy (clinical benefit documented). 3. If request is for a dose increase, the request meets ONE of the following: a) new dose does not exceed 6 mg/kg every 14 days; or b) 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 is FDA‑approved or recommended by NCCN.

Continuation criteria per section II.A.

inv-03: Updated coverage criteria (summary)

Coverage criteria have been updated over time to reflect NCCN and FDA changes and include mutation-specific pathways and combination regimen clarifications.

mutation-pathways: Policy includes distinct pathways for KRAS G12C, BRAF V600E (including combination with Braftovi with or without FOLFOX), dMMR/MSI-H, and POLE/POLD1 (POLE/POLD1 must be ultra‑hypermutated).

Derived from coding implications and revision notes in document.

disease-state-and-regimen: Policy restricts certain combinations to advanced, recurrent, or metastatic colorectal cancer and specifies that left‑sided colon requirement applies only in defined molecular contexts and for unresectable synchronous and metachronous metastases (liver and/or lung).

See 4Q2022–4Q2025 revisions.

prior-therapy-requirement: Prior therapy requirements were removed for certain single‑agent uses and for BRAF V600E combinations; prior/combination therapy requirements otherwise were simplified to align with NCCN and New Century Health guidance.

Policy revision history indicates removal/simplification.

Non-FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off-label use policies (e.g., CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for off-label uses must include supporting clinical evidence to justify medical necessity.

For colon cancer, the policy’s left-sided tumor requirement applies only when the tumor is KRAS/NRAS/BRAF wild-type, consistent with NCCN and New Century Health guidance. The left-sided definition follows NCCN (splenic flexure to rectum) and the sidedness restriction was modified to apply to colon cancer with unresectable synchronous (and where noted later, metachronous) liver and/or lung metastases in the contexts specified by the policy.

Per the FDA prescribing information and the policy updates, Vectibix (panitumumab) is not indicated for treatment of patients with RAS-mutant metastatic colorectal cancer except when used in combination with a KRAS G12C-targeted agent (e.g., sotorasib) for patients with confirmed KRAS G12C mutation. The policy includes a KRAS G12C-specific pathway aligning with the FDA-approved combination indication following prior chemotherapy.

Inclusion of procedure or billing codes in this policy (for example, J9303 for panitumumab) is provided for information only and does not guarantee coverage. If the clinical request does not meet the written approval criteria in this policy, the service may be considered not medically necessary and claims may be denied; providers should confirm coding guidance and ensure the request meets all policy criteria and documentation requirements prior to submission.

Coding

HCPCS CodesHCPCS

J9303

Injection, panitumumab, 10 mg

Referenced HCPCS CodesHCPCS

J9303

Injection, panitumumab, 10 mg

inv-10: Maximum dose — standard maximum dose every 14 days (6 mg/kg)

Maximum dose6 mg/kg every 14 days (maximum 6 mg/kg)

Administration intervalEvery 14 days (IV infusion)

Maximum single‑dose guidance6 mg/kg IV over 60 minutes (≤1,000 mg) or 90 minutes (>1,000 mg)

Dose justificationDose limit consistent with product dosing for RAS wild-type and KRAS G12C‑mutated CRC (policy and PI)

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required / Documentation

Prior authorization is required for Vectibix (panitumumab). Requests must document that the member meets the specific initial or continued therapy criteria in this policy. Provider must submit supporting clinical documentation (for example, office chart notes, labs, pathology reports, imaging, prior therapy records) demonstrating the member meets all approval criteria. Failure to submit supporting documentation may result in denial of the request.

Prior authorization may be required for certain indications and line-of-therapy requests.
For continued therapy, documentation must show the member has received Vectibix for at least 30 days and is responding to therapy (see Continued Therapy criteria).
If requesting a dose increase, provide documentation that the new dose does not exceed 6 mg/kg every 14 days or is supported by practice guidelines or peer-reviewed literature.

Documentation Required

Required Documentation

Background

Panitumumab (Vectibix) is a monoclonal antibody that antagonizes the epidermal growth factor receptor (EGFR). Its clinical activity in metastatic colorectal cancer is dependent on tumor molecular characteristics and sidedness: the FDA label and policy specify use in tumors that are RAS wild-type (wild-type in both KRAS and NRAS) and include additional, mutation-directed pathways (for example, BRAF V600E combinations and the FDA-recognized KRAS G12C indication). The policy notes that certain mutation-defined subgroups (such as dMMR/MSI-H or POLE/POLD1 with an ultra-hypermutated phenotype) have specific prior-therapy or combination requirements and that regimen choices and approvals align with NCCN and FDA guidance.

Definitions

inv-20: dMMR/MSI-H definition

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

Clinical implicationPresence qualifies for specific coverage pathway when member is ineligible for or has progressed on checkpoint inhibitor immunotherapy

Appendix referenceDefined in Appendix A of the policy's general information

inv-21: Tumor sidedness — left vs right colon definitions per NCCN

Left‑sided colon definitionLeft side defined by NCCN as splenic flexure to rectum

Right‑sided colon definitionRight side defined as hepatic flexure through cecum

Line of Therapy

inv-23: first-line | second-line | subsequent

Line of therapy: First‑line: panitumumab in combination with FOLFOX for RAS (KRAS/NRAS) wild‑type metastatic CRC; Subsequent lines: panitumumab monotherapy following progression after fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑containing chemotherapy; Additional subsequent‑line pathway: panitumumab in combination with sotorasib for KRAS G12C‑mutated CRC after prior chemotherapy (per FDA indication).

Line‑of‑therapy options summarized from FDA indications and policy criteria.

inv-24: first-line | second-line (historical references)

line-of-therapy-summary: Historically the policy referenced 'first‑line' and subsequent‑line regimens; criteria were simplified by removing the overlapping 'first‑line treatment' qualifier to better align with New Century Health and NCCN guidance and to avoid overlap with subsequent‑line regimens. CapeOx was added as an option for combination regimens per NCCN. Left‑sided colon requirement was added for KRAS/NRAS/BRAF wild‑type colon cancer in the context of unresectable disease (see Appendix D).

See 4Q2022–4Q2024 policy revisions.

Biomarker Requirements

inv-25: KRAS/NRAS — wild-type in both KRAS and NRAS as determined by an FDA-approved test

RequirementWild-type in both KRAS and NRAS as determined by an FDA‑approved test

Indication contextRequired to qualify for treatment of adult patients with wild-type RAS metastatic colorectal cancer

DocumentationTesting must be by an FDA‑approved test per the FDA indication language

inv-26: BRAF V600E — presence of BRAF V600E mutation

MutationPresence of BRAF V600E mutation

Coverage implicationAllows panitumumab use with Braftovi ± FOLFOX per NCCN; added as an option to wild-type pathway

Covered Regimens and Dosing

Regimen	Indication	Dose / Schedule	Coverage
Panitumumab in combination with FOLFOX	RAS (KRAS/NRAS) wild-type metastatic colorectal cancer; first-line per NCCN/FDA	Panitumumab 6 mg/kg IV every 14 days (maximum 6 mg/kg); administered per FOLFOX regimen	Covered with criteria

Regimen	Indication	Dose / Schedule	Coverage
Panitumumab as single agent (monotherapy)	Metastatic colorectal cancer following progression after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy	Panitumumab 6 mg/kg IV every 14 days (maximum 6 mg/kg)	Covered with criteria

Regimen	Indication	Dose / Schedule	Coverage
Panitumumab in combination with sotorasib (Lumakras/Krazati)	KRAS G12C-mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy	Panitumumab 6 mg/kg IV every 14 days in combination with sotorasib (per dosing guidance); maximum panitumumab dose 6 mg/kg	Covered with criteria

Regimen	Indication	Notes	Coverage
Panitumumab in combination with Braftovi (encorafenib) — with or without FOLFOX	BRAF V600E-mutated colorectal cancer (advanced, recurrent, or metastatic)	Combination per NCCN guidance; regimen may be with or without FOLFOX per policy updates	Covered with criteria

Regimen	Indication / Context	Dose / Schedule	Coverage
Vectibix (panitumumab) monotherapy	Metastatic colorectal cancer as monotherapy per FDA/NCCN (includes single-agent use after prior chemotherapy)	Panitumumab 6 mg/kg IV every 14 days (maximum 6 mg/kg)	Covered with criteria
Vectibix + irinotecan	mCRC in combination regimens per NCCN; option when used following prior therapy as specified in policy	Panitumumab 6 mg/kg IV every 14 days plus irinotecan per regimen-specific dosing	Covered with criteria
Vectibix + FOLFOX	mCRC; combination per NCCN and FDA for RAS wild-type first-line and other contexts per policy updates	Panitumumab 6 mg/kg IV every 14 days with FOLFOX regimen-based dosing	Covered with criteria
Vectibix + CapeOx	mCRC as combination regimen option per NCCN (CapeOx = capecitabine + oxaliplatin)	Panitumumab 6 mg/kg IV every 14 days with CapeOx regimen dosing	Covered with criteria
Vectibix + Braftovi (± FOLFOX)	BRAF V600E-mutated advanced, recurrent, or metastatic CRC; regimen may be with or without FOLFOX per NCCN and policy clarifications	Panitumumab dosing per standard 6 mg/kg every 14 days when used in combination with Braftovi; follow regimen-specific schedules for Braftovi and FOLFOX	Covered with criteria

Revision History

2021-04-01material_update

Recorded in 4Q2021 annual review: added that combination treatment with Vectibix and Braftovi is for advanced or metastatic disease and referenced coding implications.

2022-08-09annual_review

4Q2022 annual review: added qualifiers that CRC is advanced, recurrent, or metastatic; added BRAF V600E as a criterion option; simplified prior and combination therapy requirements to align with New Century Health; updated combination regimens per NCCN.

2023-08-17annual_review

Policy Summary

PayerCentene

PolicyPanitumumab (Vectibix) coverage

Policy CodePolicy CP.PHAR.321

Change TypeCriteria and pathway updates (mutation-specific additions and approval duration adjustments)

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with clinical documentation (office notes, labs, biomarker results) demonstrating the member meets the specific initial or continued therapy criteria.

SourceLink

On This Page

Providers must submit clinical documentation (office notes, lab results, pathology/immunohistochemistry reports, mutation testing results, radiology reports, and prior treatment records) to support that the member meets the policy criteria. Documentation should include, as applicable, mutation status (KRAS/NRAS/BRAF, KRAS G12C, dMMR/MSI-H, POLE/POLD1 and tumor mutation burden), prior systemic regimens, dates and responses to prior therapies, and rationale for combination or off-label regimens.

Billing Rule

Coding Inclusion Disclaimer

Inclusion of HCPCS code J9303 (Injection, panitumumab, 10 mg) and other codes in this clinical policy is for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference current professional coding guidance prior to claim submission. Incorrect coding may lead to claim denial.

HCPCS: J9303 = Injection, panitumumab, 10 mg.
Codes referenced are informational and not a guarantee of coverage.

Step Therapy

Step / Sequence Therapy Alignment

Step/sequence therapy requirements have been simplified to align with New Century Health (NCH) and NCCN recommendations. The policy allows Vectibix as a single agent or in combination with recommended regimens (for example, FOLFOX, CapeOX, FOLFIRI) and includes specific pathways for molecular subtypes (e.g., BRAF V600E, KRAS G12C, dMMR/MSI-H, POLE/POLD1) with corresponding prior-therapy or combination requirements. Prescribers must document prior therapies or rationale per the criteria when applicable.

Permitted combinations include FOLFOX, CapeOX, FOLFIRI, and irinotecan-containing regimens per NCCN.
BRAF V600E: Vectibix allowed in combination with Braftovi (with or without FOLFOX) per NCCN.
KRAS G12C and other mutation-specific pathways: follow policy criteria for required prior therapies or combination agents.