Medical Policy
Effective Date:01/01/2022 Title:Margenza (margettuximab-cmkb)
Revision Date: Document:BI690:00
CPT Code(s):J9353
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Margenza (margetuximab-cmkb) requires prior authorization.

2)    Margenza is a specialty drug covered under the medical benefit.

3)    Margenza is used to treat metastatic breast cancer.
Medical Statement

Margenza (margetuximab-cmkb) is considered medically necessary for members meeting the following criteria:

 

Breast Cancer – Initial

1)    Diagnosis of metastatic HER2-positive breast cancer; AND

2)    Prescribed by or in consultation with an oncologist; AND

3)    Age > 18 years; AND

4)    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; AND

5)    Request meets one of the following (a or b)*:

a.    Dose does not exceed 15mg/kg  every 3 weeks;

b.    Dos 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.

 

Initial approval duration: 6 months

 

Reauthorization Criteria

Breast Cancer

1)     Currently receiving the medication via QualChoice benefit or documentation supports that member is currently receiving Margenza for a covered indication and has received this medication for at least 30 days; AND

2)    Member is responding positively to therapy; AND

3)    If new request is for a dose increase, request meets one of the following (a or b)*:

a.    New dose does not exceed 15mg/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.

 

 

Codes Used In This BI:

 

J9353 Injection, margetuximab-cmkb, 5mg
Limits
Intentially left empty
Reference

1)    Margenza Prescribing Information. Rockville, MD: MacroGenics, Inc.; December 2020.

2)    National Comprehensive Cancer Network. Breast Cancer Version 1.2021.

3)    DRUGDEX System. Greenwood Village, CO: Thomson Healthcare. Updated periodically,. Accessed January 7, 2021.

Addendum:

Effective 01-01-2022: New Policy
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.