CurrentCentenePolicy CP.PHAR.522

Margetuximab-cmkb (Margenza) (PDF)

Defines medical necessity, initial and continuation approval criteria, dosing limits, duration of approval, excluded indications, coding implications and administrative requirements for margetuximab-cmkb (Margenza) across Commercial, HIM, and Medicaid lines of business for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyMargetuximab-cmkb (Margenza) (PDF)

Policy CodePolicy CP.PHAR.522

Change TypeAnnual review updates

Effective Date03.01.21

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2022 annual review: added requirement for use in combination with chemotherapy per FDA label and NCCN recommendations; updated HCPCS codes; references reviewed and updated.

1Q 2025 annual review: added criteria for fourth-line use for recurrent unresectable disease and for patients with no response to preoperative systemic therapy to align with NCCN 2A recommendations; references reviewed and updated.

1Q 2026 annual review: changed initial authorization duration from 6 months to 12 months for Medicaid/HIM; references reviewed and updated.

Multiple annual reviews (2023-2024) noted no significant clinical changes; references updated.

1FDA Approved Indication (metastatic HER2-positive breast cancer)

15 mg/kg q3wLabel Dose Limit

J9353

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Coverage Summary

Policy stance: covered_with_criteria for margetuximab-cmkb (Margenza) for the treatment of adult patients with metastatic HER2-positive breast cancer per the FDA-approved indication. The policy requires use in combination with chemotherapy and aligns with NCCN recommendations. Initial authorization durations vary by line of business: Commercial: 6 months (or to the member's renewal date, whichever is longer) and Medicaid/HIM: 12 months. The policy specifies a dosing limit of 15 mg/kg every 3 weeks per the label.

Thresholds and Quick Facts

Maximum Dose per Label15 mg/kg every 3 weeks

Minimum age≥ 18 years

Primary HCPCS CodeJ9353 (Injection, margetuximab-cmkb, 5 mg)

Medicaid/HIM Initial Approval Duration12 months

Commercial Initial Approval Duration6 months (or to member's renewal date, whichever is longer)

Indication Quick FactIndicated in combination with chemotherapy for adult patients with metastatic HER2-positive breast cancer after ≥2 prior anti-HER2 regimens (≥1 for metastatic disease)

Initial Therapy Criteria (Breast Cancer)

Initial Approval Criteria - Breast Cancer

Covered when ALL of the following are met:

Initial Therapy Criteria (Other Diagnoses/Indications)

Initial Approval Criteria - Other diagnoses/indications

If the request does not meet the breast cancer criteria:

ANY of the following

If drug recently (within last 6 months) underwent a label change not reflected in this policy, follow formulary/no-coverage or non-formulary policies as directed (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is NOT listed under section III and no recent label change, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Continuation / Renewal Criteria

Continuation/Renewal Criteria - Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports member has received Margenza for a covered indication for at least 30 days
Member is responding positively to therapy
If request is for a dose increase, must meet one of
- New dose does not exceed 15 mg/kg every 3 weeks15 mg/kg every 3 weeks
  Label maximum dose

Not Authorized / Exclusions

Not Authorized

Coverage is not authorized for:

ALL of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation per off-label policies or evidence of coverage documents is provided

Applicable Codes

HCPCS - Drug Injection CodeHCPCSCovered

J9353

Injection, margetuximab-cmkb, 5 mg

Provider Actions

Prior Authorization

Prior authorization and prescribing specialty requirement

Prescribed by or in consultation with an oncologist; prior authorization may be required for anti-HER2-based regimens and Margenza per plan processes.

Documentation Required

Support clinical criteria with documentation

Provider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

Documentation Required

Continuation documentation

For renewal, documentation must show member has received Margenza for at least 30 days and is responding positively to therapy.

Clinical Evidence & References

Evidence cited in the policy includes: "Margenza Prescribing Information (MacroGenics), Feb 2025" and "NCCN Breast Cancer Version 5.2025". The policy states it aligns criteria with the FDA label and NCCN recommendations. Therapeutic alternatives are listed in the policy appendices (Appendix B) as noted in the background, but alternatives themselves are not reproduced here.

Background

Margetuximab-cmkb (Margenza) is a HER2 receptor antagonist indicated, in combination with chemotherapy, for adults with metastatic HER2-positive breast cancer who have received two or more prior anti‑HER2 regimens, at least one of which was for metastatic disease. The policy aligns its criteria with the FDA label and NCCN recommendations and notes that therapeutic alternatives are listed in the policy (Appendix B).

Definitions

HER2human epidermal growth factor receptor 2

Margetuximab-cmkb (definition context)A HER2/neu receptor antagonist (targets HER2)

Revision History

11.20.21material_change

1Q 2022 annual review: added requirement that Margenza be used in combination with chemotherapy per FDA label and NCCN recommendations; updated HCPCS codes; references reviewed and updated.

12.02.24material_change

11.06.25material_change