Health Net Margenza Coverage Update

Coverage Criteria for Margetuximab-cmkb (Margenza)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1. Diagnosis of metastatic HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. 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; 5. For recurrent unresectable (local or regional) disease or for patients with no response to preoperative systemic therapy: failure of three anti-HER2-based regimens unless contraindicated or clinically significant adverse effects are experienced; 6. Prescribed in combination with chemotherapy (e.g., capecitabine, eribulin, gemcitabine, vinorelbine); 7. Dose does not exceed 15 mg/kg every 3 weeks (or dose supported by practice guidelines or peer-reviewed literature for relevant off-label use with supporting evidence submitted).

Must meet all listed elements

Continuation Therapy

Continued therapy — Covered when ALL of the following are met:

Continued Therapy Criteria: 1. Member is currently receiving Margenza via the Centene benefit or documentation shows the member has received Margenza for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. Current/new dose does not exceed 15 mg/kg every 3 weeks; 4. If request is for a dose increase, the request meets one of the following: dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with supporting evidence submitted; otherwise dose must not exceed 15 mg/kg q3w.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer

Updated coverage criteria (summary)

Policy alignment and criteria updates per review notes

Combination therapy requirement: Use in combination with chemotherapy is required as specified by the FDA label and NCCN recommendations.

Added in 1Q 2022

Fourth-line and preoperative nonresponse criteria: Added allowance for fourth-line use in recurrent unresectable disease and for patients with no response to preoperative systemic therapy to align with NCCN 2A recommendations.

Added in 1Q 2025

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies 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 unless coverage for the indication is supported by an evidence of coverage document.

The HCPCS and other codes shown in this policy are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers must reference current professional coding guidance and the member's plan contract when submitting claims for reimbursement.

Use of margetuximab‑cmkb (Margenza) for indications that are not FDA‑approved should follow the health plan's off‑label use requirements. Requests for off‑label use must include sufficient supporting documentation of efficacy and safety as described in the applicable off‑label policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53), or they may be denied.

This section of the policy does not contain explicit language declaring any listed indication or scenario as "not medically necessary." Determinations about medical necessity will be made based on the policy criteria, supporting documentation, and applicable off‑label use policies.

Coding and Dosing Information

HCPCS CodesHCPCS

J9353

Injection,margetuximab-cmkb_5 mg

HCPCS CodesHCPCS

J9353

Injection, margetuximab-cmkb, 5 mg

Maximum dose — 15 mg/kg every 3 weeks

Maximum dose15 mg/kg every 3 weeks

Dosing contextLimit applies to initial and continued therapy unless off-label dose is supported by guidelines or peer-reviewed literature with prescriber documentation

Related regimen notePrescribed regimen must be FDA‑approved or recommended by NCCN

Policy creation date — 01.07.21

Policy creation date01.07.21

First P&T approval recordedP&T Approval Date = 02.21

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for margetuximab-cmkb (HCPCS J9353). Approval will be granted only when the initial or continued therapy criteria in the policy are met and documentation supports medical necessity.

Prior authorization required for J9353 (margetuximab-cmkb).
Approval contingent on meeting policy clinical criteria (initial/continuation therapy).

Prior Authorization

Prior Authorization for margetuximab-cmkb (J9353)

Requests for margetuximab-cmkb billed under HCPCS code J9353 are expected to have prior authorization. Documentation should support that margetuximab is being used in combination with chemotherapy per FDA label and NCCN recommendations when applicable.

Ensure regimen documentation shows combination with chemotherapy (e.g., capecitabine, eribulin, gemcitabine, vinorelbine) when indicated.
If used off-label, prescriber must submit supporting literature or guideline evidence.

Background and Indication

Margenza (margetuximab‑cmkb) is indicated for adults with metastatic HER2‑positive breast cancer and, per this policy and FDA labeling, is to be used in combination with chemotherapy. The agent is intended for patients who have received prior anti‑HER2 therapy(s) as specified by the coverage criteria; boxed warnings include risks of left ventricular dysfunction and embryo‑fetal toxicity. The policy aligns coverage language with FDA labeling and NCCN recommendations and requires documentation that treatment is being given in combination with chemotherapy when applicable.

Definitions and Safety Notes

HER2 — Human epidermal growth factor receptor 2

HER2Human epidermal growth factor receptor 2

ContextTarget for anti‑HER2 monoclonal antibody therapies referenced in therapeutic alternatives

Abbreviation sourceDefined in Appendix A: Abbreviation/Acronym

Boxed warnings — left ventricular dysfunction and embryo-fetal toxicity

Boxed warningsLeft ventricular dysfunction; embryo-fetal toxicity

Monitoring implicationMonitor cardiac function due to risk of left ventricular dysfunction

Pregnancy implication

Initial Therapy Authorization Criteria

Initial Therapy

Initial authorization criteria for Margenza

Initial Therapy: 1. Diagnosis of metastatic HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Failure of two anti-HER2-based regimens for metastatic disease (unless contraindicated or clinically significant adverse effects); 5. For recurrent unresectable disease or patients with no response to preoperative systemic therapy: failure of three anti-HER2 regimens (fourth-line allowance as per NCCN 2A); 6. Prescribed in combination with chemotherapy (examples: capecitabine, eribulin, gemcitabine, vinorelbine); 7. Dose does not exceed 15 mg/kg every 3 weeks (or dose supported by guidelines/literature with evidence submitted).

Prior authorization may be required for anti-HER2-based regimens

Initial therapy (summary)

Initial therapy requirements referenced to FDA label and NCCN guidance

Initial therapy requirement: When initiating margetuximab-cmkb, the drug should be used in combination with chemotherapy per FDA label and NCCN recommendations; prior-line anti-HER2 regimen history must be documented and exceptions (contraindication or adverse effect) noted.

Continuation Therapy Authorization Criteria

Continuation

Continued therapy — Covered when ALL of the following are met:

Continued Therapy: 1. Member currently receiving Margenza via the Centene benefit or documentation shows at least 30 days of therapy; 2. Member is deriving clinical benefit or responding to therapy; 3. Dose remains within the 15 mg/kg every 3 weeks limit; 4. Any dose increase must be justified by guideline-supported rationale or peer-reviewed evidence submitted by prescriber.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer

Continuation therapy notes

Template changes applied to continued therapy section noted during reviews

Continuation wording: Template and wording changes were applied to the continued therapy section during routine reviews; no substantive clinical criteria were removed in these template revisions.

1Q 2022 and subsequent template updates

Step Therapy and Prior Regimen Requirements

Step	Requirement	Notes
1	Must document prior anti-HER2 regimen failures unless contraindicated or clinically significant adverse effects prevent use	For metastatic disease: failure of two anti-HER2–based regimens, at least one for metastatic disease; for recurrent unresectable disease or patients with no response to preoperative systemic therapy: failure of three anti-HER2–based regimens (see Appendix B).

Step	Requirement	Notes
0	Policy notes allow later-line (fourth-line) use and permit consideration for patients with no response to preoperative systemic therapy per NCCN 2A guidance	No explicit step-sequence or mandated prior-regimen failures are specified in this policy segment for these scenarios; alignment with NCCN and documentation supporting line-of-therapy rationale is required.

Quantity and Dosing Limits

Margetuximab-cmkb (Margenza) — Dose capped at 15 mg/kg

Dose capDose capped at 15 mg/kg

Vial sizeSingle‑dose vial: 250 mg/10 mL

ApplicationCap applies to initial and continued therapy per policy dosing and quantity limits

Site of Care and Administration

Note

Infusion administration implied (no site restriction)

Margetuximab-cmkb is implied to be administered in outpatient infusion settings when given in combination with chemotherapy; the policy does not impose an explicit site‑of‑care restriction.

Administered with chemotherapy agents (implies infusion center or outpatient infusion setting)
No explicit site restriction stated in policy

OpenPayer

Margetuximab-cmkb (Margenza) coverage