CurrentmhnPolicy CP.PHAR.522

Clinical Policy: Margetuximab-cmkb (Margenza)

Policy governs medical necessity criteria, initial and continuation approval, dosing limits, documentation and approval durations for margetuximab-cmkb (Margenza) across Commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Margetuximab-cmkb (Margenza)

Policy CodePolicy CP.PHAR.522

Change TypeMaterial and non-material revisions

Effective Date03.01.21

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

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 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 2022 and subsequent annual reviews: template changes applied to other diagnoses/indications and continued therapy section; references reviewed.

1FDA Approved Indication (breast cancer)

≤15 mg/kgMax dose every 3 weeks

6 months

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Coverage Summary

Coverage stance: covered_with_criteria for margetuximab-cmkb (Margenza) when used for metastatic HER2-positive breast cancer per the FDA label and NCCN guidance. The policy requires use in combination with chemotherapy and defines specific prior anti-HER2 regimen failure thresholds for line-of-therapy determination. Scope: governs medical necessity criteria, initial and continuation approval, dosing limits, documentation and approval durations across Commercial, HIM and Medicaid lines of business. Effective date: 03.01.21. Last review date: 02.25.

Thresholds & Approval Durations

Maximum Dose15 mg/kg every 3 weeks

Continuation minimum exposureMember has received medication for at least 30 days

Initial approval duration (Medicaid/HIM)6 months

Continued approval duration (Medicaid/HIM)12 months

Dose requirementDose must not exceed 15 mg/kg every 3 weeks unless supported by guidelines or literature (prescriber must provide evidence)

I. Initial Approval Criteria - Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Diagnosis of metastatic HER2-positive breast cancer
Prescribed by or in consultation with an oncologist
Age >= 18 years
Member meets one of the following (a or b)
- a: For metastatic disease: failure of two anti-HER2-based regimens, at least one of which was for metastatic disease, unless contraindicated or clinically significant adverse effects are experienced

I. Initial Approval Criteria - Other diagnoses/indications

If not meeting primary criteria or policy not up to date, follow formulary/non-formulary or off-label policies:

ANY of the following

If drug underwent label change within last 6 months not reflected in this policy, follow appropriate no-coverage or non-formulary policy for the relevant line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.190)
See policy for line-of-business specifics
If requested use is not listed under section III and criterion 1 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)

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II. Continued Therapy (Breast Cancer)

Covered when ALL of the following are met:

ALL of the following

Member currently receiving medication via Centene benefit, or documentation supports member has been receiving Margenza for a covered indication for at least 30 days
Continuation minimum exposure
Member is responding positively to therapy
If request is for dose increase, must meet one:
- New dose does not exceed 15 mg/kg every 3 weeks≤ 15 mg/kg every 3 weeks
  Maximum approved dose for breast cancer

III. Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

See off-label policies for required documentation

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Provider Actions

Prior Authorization

Prior authorization for Margenza

Prior authorization may be required for Margenza. Requests will be evaluated against the policy criteria and prescriber must provide evidence if the dose exceeds 15 mg/kg every 3 weeks or if the requested use is off-label and not FDA- or NCCN-recommended.

Affected HCPCS code: J9353

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation such as office notes, lab results, or other clinical information demonstrating that the member has met all approval criteria.

Documentation Required

Oncologist involvement

Applicable Codes

Primary HCPCS code for drugHCPCSCovered

J9353

Injection, margetuximab-cmkb, 5 mg

Clinical Evidence & References

Primary evidence references listed in the policy: Margenza Prescribing Information May 2023 and NCCN Breast Cancer Version 6.2024. The policy references the FDA label and NCCN guidance and provides a list of therapeutic alternatives in Appendix B (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine, fam-trastuzumab-deruxtecan).

Background

Background: Margetuximab-cmkb (Margenza) is a HER2 receptor antagonist indicated, in combination with chemotherapy, for adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens (at least one for metastatic disease).

Definitions & Policy Metadata

HER2 definitionhuman epidermal growth factor receptor 2

Policy numberCP.PHAR.522

Payermhn

Policy title & effective dateClinical Policy: Margetuximab-cmkb (Margenza) — Effective Date: 03.01.21

Revision History

2025-01-01materialLatest

1Q 2025 annual review: added criterion requiring failure of three anti-HER2 regimens for recurrent unresectable disease or for patients with no response to preoperative systemic therapy (aligns with NCCN 2A); references reviewed and updated.

2022-01-01material

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

2023-01-01