CurrentmhnPolicy CP.PHAR.321

Panitumumab (Vectibix)

Defines medical necessity criteria, initial and continued authorization rules, dosing, limitations, and coding implications for panitumumab (Vectibix) for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPanitumumab (Vectibix)

Policy CodePolicy CP.PHAR.321

Change TypeMultiple material revisions (2021-2025)

Effective Date03.01.17

Next Review Date

Key ActionPrior authorization may be required; provider must submit documentation (office notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added combination treatment with Vectibix and Braftovi for advanced or metastatic disease (8/09/2021; P&T 11/21).

Added BRAF V600E mutation positive option and simplified prior/combination therapy requirements per NCCN (4Q2022; P&T 11/22).

Removed reference to formulary exception for HIM Vectibix 400 mg to apply policy to all formulations; added CapeOX; required left-sided only for certain wild-type colon cancers (4Q2023; P&T 11/23).

Per NCCN added pathways for KRAS G12C, dMMR/MSI-H, and POLE/POLD1 mutations with combination/prior therapy requirements; removed prior therapy requirement when requested as single agent; modified left-sided requirement to apply only to unresectable synchronous/metachronous disease; extended HIM/Medicaid initial approval duration to 12 months; commercial authorization standardized (4Q2024; P&T 11/24).

Added new FDA-approved indication for KRAS G12C-mutated mCRC and updated combinations and left-sided criteria (2025 revisions).

Specified POLE/POLD1 mutation positive disease must have ultrahypermutated phenotype (TMB > 50 mut/Mb) (4Q2025; P&T 11/25).

Approval durations revised: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer.

5Covered molecular indications listed

Coverage Summary

Coverage stance: covered with criteria for panitumumab (Vectibix) for adult patients with metastatic, recurrent, or advanced colorectal cancer per the policy.

High-level coverage requirements (bullets):

- Genomic testing: documentation of KRAS/NRAS and relevant mutation status (e.g., BRAF V600E, KRAS G12C, dMMR/MSI-H, POLE/POLD1) as applicable is required.

- Tumor location: for KRAS/NRAS/BRAF wild-type colon cancer with unresectable synchronous or metachronous liver and/or lung metastases, tumor must be left-sided (left side defined as splenic flexure to rectum).

- Dosing: maximum recommended dosing is 6 mg/kg every 14 days (dose limits and administration per policy/dosing section).

- Prior therapy/combination constraints: use may be as single agent or in specific combinations (e.g., with FOLFOX, CapeOX, FOLFIRI, irinotecan after prior therapy, with Braftovi for BRAF V600E, with sotorasib for KRAS G12C per FDA); some genotypes (dMMR/MSI-H, POLE/POLD1) require ineligibility for or progression on checkpoint inhibitor therapy.

Key thresholds & quick facts

Maximum dose6 mg/kg every 14 days

POLE/POLD1 ultrahypermutated phenotypeTumor mutation burden (TMB) > 50 mut/Mb

Approval durationsMedicaid/HIM: 12 months; Commercial: 6 months (or to member renewal date)

Primary HCPCS codeJ9303

Initial Therapy Criteria — Colorectal Cancer

Initial Approval Criteria - Colorectal Cancer

Covered when ALL of the following are met:

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Initial Therapy Criteria — Other Diagnoses/Indications

Initial Approval Criteria - Other diagnoses/indications

Covered when ONE of the following is met:

ANY of the following

If the drug has had a recent label change (within last 6 months) not reflected in this policy, follow the no coverage criteria policy or non-formulary policy referenced for the relevant line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable).
If requested use is not listed under section III (not-covered) and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Continuation Therapy Criteria — Colorectal Cancer

Continued Therapy - Colorectal Cancer

Continued coverage when ALL of the following are met:

ALL of the following

Member is currently receiving Vectibix via Centene benefit or documentation supports current receipt for a covered indication and has received medication for at least 30 days.
Member is responding positively to therapy.
If request is for a dose increase
- New dose does not exceed 6 mg/kg every 14 days.Maximum dose 6 mg/kg q14d

Continuation Therapy Criteria — Other Diagnoses/Indications

Not Authorized / Exclusions

Provider Actions & Requirements

Prior Authorization

Prior authorization may be required

Prior authorization may be required; provider must submit documentation (office notes, lab results or other clinical information) supporting that member meets all approval criteria.

Documentation Required

Genomic testing documentation

Genomic testing documentation — Provider must document RAS (KRAS/NRAS) and BRAF mutation status or other mutation status (KRAS G12C, BRAF V600E, dMMR/MSI-H, POLE/POLD1) as applicable; if POLE/POLD1, document ultrahypermutated phenotype (TMB > 50 mut/Mb).

Applicable Codes

HCPCS - Drug J-codeHCPCSCovered

J9303

Injection, panitumumab, 10 mg

Clinical Evidence & References

Primary evidence sources: Vectibix Prescribing Information (Amgen), June 2025 (primary reference).

Guideline sources: NCCN Colon Cancer Version 4.2025 and NCCN Colon/Rectal compendium entries (accessed July 2025).

The policy notes that combination regimens and mutation-specific pathways align with FDA labeling and NCCN updates through 2025.

Background

Panitumumab (Vectibix) is an EGFR antagonist indicated for adult patients with wild-type RAS metastatic colorectal cancer (wild-type KRAS and NRAS as determined by an FDA-approved test).

Additional FDA- and NCCN-supported uses include combinations for specific mutations (for example, combination with sotorasib for KRAS G12C-mutated mCRC, and combination with Braftovi ± FOLFOX for BRAF V600E), and other genotype-directed pathways included in the policy.

This policy aligns coverage with FDA labeling and NCCN recommendations and requires appropriate genomic testing, tumor location considerations (left-sided requirement for certain wild-type colon cancer scenarios), dosing limits, and prior therapy documentation where specified.

Quick reference

Covered molecular indications listed5

Maximum recommended dosing6 mg/kg q14d

Approval durationsMedicaid/HIM 12 months; Commercial 6 months

Primary HCPCS code

Definitions

Left-sided colon: defined as the colon from the splenic flexure to the rectum (per NCCN Appendix D).

dMMR/MSI-H: defined as deficient mismatch repair / microsatellite instability-high.

POLE/POLD1 ultrahypermutated phenotype: defined as tumor mutation burden (TMB > 50 mutations per megabase).

Revision History

08/09/2021added

Added combination treatment with Vectibix and Braftovi for advanced or metastatic disease; documented in revision log (P&T 11/21).

4Q2022revised

Added BRAF V600E mutation positive option and simplified prior/combination therapy requirements per NCCN; aligned qualifiers that CRC is advanced, recurrent, or metastatic.

4Q2023revised

Removed reference to formulary exception for HIM Vectibix 400 mg formulation to apply policy to all formulations; added CapeOX as a combination regimen; required left-sided only for certain KRAS/NRAS/BRAF wild-type colon cancers.