CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Margenza (margetuximab-cmkb) — Coverage Criteria

Defines accepted indications, exclusion criteria, and coding for Margenza (margetuximab-cmkb) for cancer treatment requests processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMargenza (margetuximab-cmkb) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionexclusion and verbiage updates

Effective DateN/A

Next Review DateFeb 1, 2025

Key ActionSubmit prior authorization requests to Evolent with evidence per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or supportive peer-reviewed literature and ensure dosing does not exceed 15 mg/kg per single dose.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1420 Margenza policy.

Updated exclusion criteria and updated NCH verbiage to Evolent.

15 mg/kgsingle dose maximum for Margenza

J9353HCPCS code (5 mg)

Phase 3 SOPHIAtrial cited

Commercial, Exchange, Medicaidlines of business

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Coverage Criteria

Covered when ALL of the following are met:

General authorization requirements: Use must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS standards; Evolent must process and authorize medication requests; continuation requests are permitted only when prior authorization is active within the past year without >30-day lapse and there is no disease progression or addition of new medications.

sources: chunk 1

Metastatic HER2+ breast cancer: Margenza (margetuximab-cmkb), with or without chemotherapy, is not supported by Evolent policy for the treatment of metastatic HER2-positive breast cancer based on Phase 3 SOPHIA trial data showing no significant overall survival benefit versus trastuzumab plus chemotherapy.

sources: chunk 3

Requests for Margenza (margetuximab-cmkb) that propose dosing above the single dose limit of 15 mg/kg will be excluded and may be denied. In addition, uses that are investigational or off-label without sufficient evidence are not approvable. The policy defines sufficient evidence as support from FDA labeling, CMS-recognized compendia, or acceptable peer-reviewed literature; evidence is considered insufficient when patient or regimen characteristics are not represented, outcomes are not clinically meaningful (for example, lacking an expected hazard ratio < 0.80 or at least a 3-month survival benefit for OS/PFS where applicable), study design is inappropriate for the question, or when supporting information consists only of case reports or abstracts without full peer-reviewed articles.

Margenza (margetuximab-cmkb) for treatment of metastatic HER2-positive breast cancer is not supported by Evolent. This position is based on the Phase 3 SOPHIA trial, which showed no significant overall survival benefit for margetuximab (with or without chemotherapy) versus trastuzumab plus chemotherapy. Providers should refer to alternative agents and regimens recommended by Evolent (for example, via Evolent Pathways) rather than seeking approval for Margenza in this indication.

Regimen evaluated	Comparator	Evidence source	Policy coverage stance
Margetuximab (Margenza) with or without chemotherapy
Trastuzumab plus chemotherapy
Phase 3 SOPHIA trial (Rugo HS, et al.)
Not supported for treatment of metastatic HER2-positive breast cancer based on SOPHIA showing no significant overall survival benefit versus trastuzumab + chemotherapy

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Margenza (margetuximab-cmkb) and is processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island. Requests must be submitted prior to drug administration and will be reviewed against evidentiary support, dosing limits, and policy criteria. Continuation requests may be exempt when the member has not progressed, the prior authorization has been active within the past year with no lapse greater than 30 days, and no additional medications are being added to the regimen.

Evolent processes all medication prior authorization requests for this agent.
Continuation requests exempt from full review when: no disease progression; prior authorization active within last year with <=30-day lapse; no additional medications added.

Documentation Required

Required Supporting Documentation

Support for use must include one or more of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Requests lacking adequate supporting evidence or relying solely on uncontrolled case reports or abstracts without full peer-reviewed articles may be denied.

Acceptable evidence: FDA labeling; CMS-recognized compendia; NCCN or ASCO guidelines; peer-reviewed literature meeting CMS criteria.
Insufficient evidence examples: case reports, meeting abstracts without full peer-reviewed publication, or evidence that does not adequately represent patient clinical characteristics, regimen, or clinically meaningful outcomes.

Note

Preferred Alternatives

Evolent recommends alternative agents/regimens per Evolent Pathways. Margenza is not supported by Evolent policy for metastatic HER2-positive breast cancer based on the Phase 3 SOPHIA trial which showed no significant overall survival benefit compared with trastuzumab plus chemotherapy. Refer to Evolent Pathways for preferred alternatives.

Margenza use in metastatic HER2+ breast cancer is not supported; consider alternative trastuzumab-based regimens per Evolent Pathways.
Consult Evolent Pathways for recommended alternative agents/regimens.

Drug Background and Context

Margenza (margetuximab-cmkb) is an anti-HER2 monoclonal antibody used in oncology. Evolent reviews requests for Margenza against FDA labeling, CMS-recognized compendia, national guidelines, and peer-reviewed literature. For metastatic HER2-positive breast cancer, the Phase 3 SOPHIA trial did not demonstrate a significant overall survival advantage versus trastuzumab plus chemotherapy, which informs the policy stance. Authorization decisions also incorporate dosing limits (notably a 15 mg/kg single dose maximum) and the requirement for adequate supporting evidence for off-label uses.

Evidence and Terminology

Sufficient evidence — acceptable evidence sources

Primary acceptable evidenceFDA approved product labeling (prescribing information)

Recognized compendia and guidelinesCMS‑recognized compendia, NCCN, and ASCO clinical guidelines

Peer‑reviewed literature standardsPeer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements; excludes abstracts without full articles and uncontrolled case reports

Evidence quality considerationsAssessment includes representativeness of patient/cancer characteristics, regimen representation, clinically meaningful outcomes (e.g., ASCO definitions), and appropriate study design

Regimens and Comparative Evidence

Covered regimen	Notes / rationale	Action for providers
Margetuximab (Margenza) with or without chemotherapy vs trastuzumab + chemotherapy (SOPHIA trial)
Phase 3 SOPHIA demonstrated no significant overall survival benefit of margetuximab ± chemotherapy compared with trastuzumab + chemotherapy; Evolent does not support this use for metastatic HER2+ breast cancer.
Refer to Evolent-recommended alternative agents/regimens (Evolent Pathways); do not submit requests expecting approval for Margenza in this indication absent compelling new evidence.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMargenza (margetuximab-cmkb) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionexclusion and verbiage updates

Effective DateN/A

Next Review DateFeb 1, 2025

SourceLink

On This Page

OpenPayer

Margenza (margetuximab-cmkb) — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing Codes and Dose Limits

Prior Authorization, Documentation, and Provider Guidance

Drug Background and Context

Evidence and Terminology

Line of Therapy Applicability

Biomarker and Test Requirements

Regimens and Comparative Evidence