ModifiedmhnPolicy CP.PHAR.522

Margetuximab-cmkb (Margenza) coverage

Medical necessity and prior authorization criteria for margetuximab-cmkb (Margenza) for treatment of metastatic HER2-positive breast cancer and related coverage guidance for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyMargetuximab-cmkb (Margenza) coverage

Policy CodePolicy CP.PHAR.522

Change TypeAuthorization duration revised (Commercial 6 mo → Medicaid/HIM 12 mo) — material

Effective Date03.01.21

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, prior anti‑HER2 regimen history, prescriber specialty, dosing (≤15 mg/kg Q3W unless supported) and documentation that regimen includes combination with chemotherapy.

SourceLink

POLICY UPDATE CHANGES

Changed initial authorization duration from 6 months to 12 months for Medicaid/HIM.

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.

Added requirement for use in combination with chemotherapy per FDA label and NCCN recommendations.

15 mg/kg Q3WMax dose

J9353HCPCS

250 mgVial size

12 moInitial approval (Medicaid/HIM)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

inv-01: Initial Therapy - Breast Cancer

Covered when ALL of the following are met:

Breast Cancer initial: 1. Diagnosis of metastatic HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. 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 intolerant; (b) For recurrent unresectable (local or regional) or metastatic disease or for patients with no response to preoperative systemic therapy: failure of three anti-HER2-based regimens unless contraindicated or intolerant; 5. Prescribed in combination with chemotherapy (e.g., capecitabine, eribulin, gemcitabine, vinorelbine); 6. Request meets one of the following (a or b): (a) Dose does not exceed 15 mg/kg every 3 weeks; (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Prescribed regimen must be FDA-approved or recommended by NCCN

See Appendix B for therapeutic alternatives

inv-02: Continuation Therapy - Breast Cancer

Continued therapy covered when ALL of the following are met:

Breast Cancer continued: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Margenza for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the request meets one of the following (a or b): (a) New dose does not exceed 15 mg/kg every 3 weeks; (b) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Prescribed regimen must be FDA-approved or recommended by NCCN

Approval durations: Medicaid/HIM - 12 months; Commercial - 6 months or to the member's renewal date

Requests for use of margetuximab-cmkb (Margenza) for indications that are not FDA‑approved and not specifically addressed in this policy will be excluded from coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage determinations for margetuximab-cmkb are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This clinical policy is a guide to medical necessity and does not guarantee payment; applicable state and federal requirements and Health Plan administrative policies also apply.

Uses of margetuximab-cmkb that are non‑FDA approved and that do not meet the policy criteria or the off‑label evidence requirements described in the referenced off‑label use policies are considered not authorized for coverage and will be denied.

Coding

HCPCS CodesHCPCS

J9353

Injection, margetuximab-cmkb, 5 mg

inv-07: Maximum dose — 15 mg/kg every 3 weeks

Maximum dose15 mg/kg every 3 weeks (IV)

Dose contextListed as the dosing regimen and maximum dose for breast cancer indication

Dosing cyclePer 3-week dosing cycle

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Margetuximab (Margetuximab-cmkb). Requests must document the diagnosis, prior anti‑HER2 therapy history (see Appendix B), prescriber specialty (oncologist or consultation with oncologist), age, planned dosing and schedule (dose must not exceed 15 mg/kg every 3 weeks unless supported by practice guidelines or peer‑reviewed literature), and that the drug will be used in combination with an appropriate chemotherapy agent. Prior authorization requests should include supporting clinical documentation (office notes, labs, pathology reports, treatment history) demonstrating that the member meets the specific approval criteria for the requested indication.

Request must document diagnosis and prescriber specialty
Document prior anti‑HER2 regimens and reason for discontinuation (see Appendix B)
Dose ≤ 15 mg/kg every 3 weeks unless guideline-supported
Include supporting clinical documentation (office notes, labs, treatment history)

Background

Margetuximab-cmkb (Margenza) is a human epidermal growth factor receptor 2 (HER2) antagonist indicated in combination with chemotherapy for the treatment of adult patients with metastatic HER2‑positive breast cancer after specified prior anti‑HER2 regimens. The policy aligns with the FDA label and guideline recommendations and notes important safety considerations including boxed warnings for left ventricular dysfunction and embryo‑fetal toxicity.

Definitions

inv-17: Margetuximab-cmkb (Margenza) — key drug definition and indication

Drug name (generic; brand)Margetuximab-cmkb (Margenza)

Drug classHuman epidermal growth factor receptor 2 (HER2) receptor antagonist

FDA indicationIndicated, in combination with chemotherapy, for treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one for metastatic disease.

inv-18: Definitions — additional definition entries (blank label in inventory)

Policy purposeProvides a guide to medical necessity to assist in coverage decisions; not a guarantee of payment.

Development basisDeveloped by licensed health care professionals using standards of medical practice, peer-reviewed literature, agency approvals, guidelines, and expert opinion.

Initial Therapy

inv-19: Initial Therapy — Initial authorization criteria (detailed nested criteria)

Initial authorization criteria

Initial Margenza: 1. Adult (≥18 years) with metastatic HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Member has failed required prior anti-HER2 regimens as applicable: failure of two anti-HER2-based regimens for metastatic disease (at least one for metastatic disease) unless contraindicated or intolerant, OR failure of three anti-HER2-based regimens for recurrent unresectable or metastatic disease or for no response to preoperative systemic therapy unless contraindicated or intolerant; 4. Prescribed in combination with chemotherapy (examples: capecitabine, eribulin, gemcitabine, vinorelbine); 5. Dose does not exceed 15 mg/kg every 3 weeks OR dose is supported by practice guidelines or peer-reviewed literature with submitted evidence; 6. Prescribed regimen must be FDA-approved or recommended by NCCN

Approval durations vary by line of business (see continuation criteria)

Continued Therapy

inv-20: Continued Therapy — Requirements for continued coverage

Requirements for continued coverage

Continued Margenza: 1. Member has been receiving Margenza via the Centene benefit or has documentation showing receipt of Margenza for at least 30 days; 2. Member is responding positively to therapy; 3. For any requested dose increase, new dose must either not exceed 15 mg/kg every 3 weeks or be supported by practice guidelines or peer-reviewed literature with submitted evidence; 4. Prescribed regimen must be FDA-approved or recommended by NCCN

Approval durations: Medicaid/HIM 12 months; Commercial 6 months or to renewal date

Step Therapy / Prior Regimen Documentation

Requirement	Details / acceptable documentation
Failure of prior anti-HER2 regimens for metastatic disease
Member must have failed two anti-HER2–based regimens, at least one of which was for metastatic disease, unless contraindicated or intolerant; see Appendix B for therapeutic alternatives
Failure of prior anti-HER2 regimens for recurrent unresectable or certain other settings
For recurrent unresectable (local or regional) or metastatic disease, or for patients with no response to preoperative systemic therapy: failure of three anti-HER2–based regimens unless contraindicated or intolerant; see Appendix B for therapeutic alternatives
Documented contraindication or intolerance to prior anti-HER2 therapy
Medical record documentation (e.g., office notes, treatment history, adverse event records) supporting contraindication or clinically significant adverse effects to prior anti-HER2 regimens

Quantity Limits

inv-22: Margetuximab-cmkb (Margenza) — quantity/dose limit 15 mg/kg

Quantity / dose limit15 mg/kg per 3-week dosing cycle

Vial sizeSingle-dose vial: 250 mg/10 mL

Billing unitDose expressed as mg/kg; HCPCS billing uses J9353 (5 mg) per policy coding guidance)

Site of Care

Step Therapy

Administered by infusion and must be combined with chemotherapy

Margenza must be administered by infusion per the dosing regimen and is required to be prescribed in combination with chemotherapy to meet the clinical policy criteria.

Administered in an infusion center per dosing regimen
Prescribed in combination with chemotherapy