Medical Drug Criteria (MDC)

MDC Num:     P1.001.006
MDC Name:   MARGENZA® (margetuximab-cmkb)
MDC ID:        [P1.001.006] [Ac /L / M+ / P+ ] [0.00.00]

Last Review:      September 17, 2024
Next Review:      September 20, 2025

Related MDC: None

MARGENZA® (margetuximab-cmkb)

Summary

Margenza is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.  Margetuximab-cmkb is a chimeric Fc-engineered IgG1 kappa monoclonal antibody, that binds to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). Upon binding to HER2-expressing tumor cells, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC)

POLICY STATEMENT

Margenza may be considered medically necessary in patients 18 years of age or older for the treatment of metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 regimens, and if the conditions indicated below are met. 
 

POLICY GUIDELINES

Coverage eligibility for margetuximab-cmk (Margenza) will be considered when the following criteria are met:

• Authorization of 12 months may be granted for treatment of of metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 regimens including:
  • Pertuzumab + trastuzumab + docetaxel 
  • Pertuzumab + trastuzumab + paclitaxe
  • Fam-trastuzumab deruxtecan-nxki
  • Tucatinib + trastuzumab + capecitabine
  • Ado-trastuzumab emtansine

DOSAGE/ADMINISTRATION:

The recommended dose of Margenza is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

a)    Diagnosis of metastatic breast cancer; AND 
b)    Prescribed by an oncologist or hematologist; AND 
c)    Age ≥ 18 years; AND
d)    Member has HER2-positive disease defined as ONE of the following: 

a.    Immunohistochemistry (IHC) is 3+
b.    Fluorescent in situ hybridization (FISH) HER2 gene copy is greater than or equal to 6 signals/cell
c.    FISH ratio of HER2 gene/chromosome 17 ratio is greater than or equal to 2.0

e)   Member has received two or more anti-HER2 treatments (ado-trastuzumab (Kadcyla), fam-trastuzumab deruxtecan-nxki injection (Enhertu), trastuzumab (Herceptin), pertuzumab (Perjeta) 
f)    Use will be in combination with chemotherapy
g)   Use will not be in combination with another anti-HER2 regimen 
h)   Dose does not exceed 15 mg/kg every 21 days
i)    Document: Patient’s actual body weight
 

Renewal Approval Criteria

a) The patient is currently receiving margetuximab-cmk and continues to meet initial criteria; AND  
b) The patient has continued clinical benefit on margetuximab-cmk therapy as demonstrated by tumor response or lack of disease progression, and an acceptable toxicity profile
 

EXCLUSION CRITERIA

None

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

Population Reference No. 1 Policy Statement

REFERENCES

1.    Margetuximab-cmkb. In: DRUGDEX [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2023 [cited 2023 September 14]. Available from: www.micromedexsolutions.com. Subscription required to view.
2.    MARGENZA(TM) intravenous injection, margetuximab-cmkb intravenous injection. MacroGenics Inc (per manufacturer), Rockville, MD, 2020.

Codes

Applicable Modifiers

N/A

Policy History