CurrentAetnaPolicy N/A

MARGENZA (margetuximab-cmkb) Precertification Request Form

Precertification notification and information form for Aetna providers requesting authorization for Margenza (margetuximab-cmkb), used primarily for breast cancer treatment; applies to Aetna members and their providers submitting prior authorization requests.

Policy Summary

PayerAetna

PolicyMARGENZA (margetuximab-cmkb) Precertification Request Form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form (or Medicare form for MA Part B) to Aetna for prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page(s) in document

1-866-752-7021Aetna precertification phone

1-888-267-3277Aetna precertification fax

Breast cancerindication listed for initiation requests

HER2 requiredbaseline tumor biomarker field

Coverage Criteria and Clinical Information

inv-01: Initiation Requests — criteria and data elements requested for initiation (breast cancer).

Information requested for initiation requests (breast cancer):

Initiation request information: Request must include indication (breast cancer); clinical setting (select one: recurrent unresectable disease, metastatic disease, disease had no response to preoperative systemic therapy, or other); HER2 status (positive, negative, or unknown); whether the drug will be used in combination with chemotherapy (yes/no); and whether the patient has received two or more prior regimens (yes/no).

Collected to inform medical necessity review

inv-02: Continuation Requests — criteria and data elements requested for continuation requests.

Information requested for continuation requests:

Continuation request information: Request must include documentation of whether there is evidence of unacceptable toxicity or disease progression while on the current regimen (yes/no).

Used to determine continuation appropriateness

Policy Summary

PayerAetna

PolicyMARGENZA (margetuximab-cmkb) Precertification Request Form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form (or Medicare form for MA Part B) to Aetna for prior authorization review.

SourceLink

On This Page

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.

The form does not list specific clinical exclusions. For initiation requests the form collects the indication (Breast cancer) and asks the provider to indicate the clinical setting in which Margenza will be used: recurrent unresectable disease, metastatic disease, disease with no response to preoperative systemic therapy, or other. The form also requires documentation of HER2 status (positive / negative / unknown), whether the drug will be used in combination with chemotherapy (yes/no), and whether the patient has received two or more prior regimens (yes/no) to inform the medical necessity review.

For continuation requests the form requires documentation of the date of last treatment and explicitly asks whether there is evidence of unacceptable toxicity or disease progression while on the current regimen (yes/no). The acknowledgement section also warns that knowingly providing materially false or incomplete information is a fraudulent insurance act and that the plan may request additional information or clarification if needed to evaluate the request; these provisions underscore that evidence of progression or toxicity may be solicited and can affect authorization decisions.

Initial Therapy Documentation Requirements

inv-13: Initiation therapy documentation — specific initiation data elements requested to assess initial coverage eligibility.

Initiation data elements requested to assess initial coverage eligibility.

Initiation documentation: Indication: breast cancer; Clinical setting: recurrent unresectable disease, metastatic disease, no response to preoperative systemic therapy, or other (select one); HER2 status: positive, negative, or unknown; Will be used in combination with chemotherapy: yes/no; History of two or more prior regimens: yes/no.

Collected for initial therapy authorization

Continuation Therapy Documentation Requirements

inv-14: Continuation therapy documentation — documentation regarding current regimen response or toxicity required for continuation requests.

For continuation requests the form requires documentation regarding current regimen response or toxicity.

Continuation documentation: Date of last treatment; Is there evidence of unacceptable toxicity or disease progression while on the current regimen? (yes/no).

Supports decision on continuing therapy

Coding and Billing

Administration/CPT codesCPT

Administration code(s) (CPT)

Field to indicate CPT administration codes

ICD codesICD-10

Primary ICD Code	Field to enter primary ICD diagnosis code
Secondary ICD Code	Field to enter secondary ICD diagnosis code
Other ICD Code	Field to enter other ICD diagnosis code

Provider Actions and Submission Requirements

Prior Authorization

Precertification Required

Prior authorization (precertification) is required via Aetna Precertification Notification for Margenza (margetuximab-cmkb). Requests may be submitted by phone or fax; use the Medicare Request Form for Medicare Advantage Part B.

Submit precertification via Aetna Precertification Notification
Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277

Documentation Required

Required Clinical Documentation — Initiation

For initiation requests, documentation must confirm the clinical setting (recurrent unresectable, metastatic, lack of response to preoperative systemic therapy, or other) and HER2 status, and whether Margenza will be used in combination with chemotherapy.

Clinical setting: recurrent unresectable disease, metastatic disease, no response to preoperative systemic therapy, or other (specify)
HER2 status: positive, negative, or unknown
Will drug be used with chemotherapy? Yes/No

Documentation Required

Required Clinical Documentation — Continuation

For continuation requests, documentation must include date of last treatment and whether there is evidence of unacceptable toxicity or disease progression while on the current regimen.

Date of last treatment
Document presence or absence of unacceptable toxicity or disease progression

Documentation Required

Prior Regimens Documentation

The form asks whether the patient has received two or more prior regimens; prior therapy history is required for initiation assessment and must be clearly documented.

Indicate if patient received ≥2 prior regimens (Yes/No)
Provide details of prior regimens and dates

Denial Risk

Incomplete or Fraudulent Information — Warnings

All required clinical information (including start of treatment date for initiation requests or date of last treatment for continuation) must be completed and legible. The plan may request additional information or clarification; knowingly providing false or incomplete information may lead to denial and could be subject to fraud penalties.

Include start date of treatment for initiation requests
Include date of last treatment for continuation requests
Complete all fields legibly to avoid delays or requests for additional information
Fraudulent or materially false information may result in denial and civil/criminal penalties

Place of Administration

Note

Specify place of administration

Specify the place of administration on the form by selecting the appropriate option: self-administered, physician's office, outpatient infusion center, or home infusion center.

Place of Administration options: Self-administered; Physician's Office; Outpatient Infusion Center; Home Infusion Center

Key Definitions

Human epidermal growth factor receptor 2 (HER2) status

HER2 positiveSelected when tumor testing indicates overexpression or amplification of HER2 (documented as HER2 positive on the form)

HER2 negativeSelected when tumor testing indicates no overexpression or amplification of HER2 (documented as HER2 negative on the form)

HER2 unknownSelected when HER2 status is not available or has not been determined (documented as Unknown on the form)

Background and Drug Information

Margetuximab-cmkb (Margenza) is requested on this precertification form for the indication of breast cancer. The form collects the drug name and dosing fields and specifically captures the patient’s HER2 status (positive, negative, or unknown) as a required baseline tumor biomarker to support medical necessity review.

Step Therapy and Prior Regimen History

Required prior regimen history	How information is used
Has the patient received treatment with two or more prior regimens? (Yes / No)
This response is used to inform step therapy requirements and initial authorization decisions; providers must indicate prior regimen history on the form.