Mogamulizumab-kpkc (Poteligeo)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019

Description

Mogamulizumab-kpkc (Poteligeo ) is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. CCR4 is expressed on the surface of some T-cell malignancies. Mogamulizumab-kpkc (Poteligeo) binding targets a cell for antibody-dependent cellular cytotoxicity and results in depletion of the target cells. 

Criteria

Coverage is subject to the specific terms of the member's benefit plan. 

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website. 

Food and Drug Administration (FDA) Indications

Mogamulizumab-kpkc (Poteligeo) may be considered medically necessary for the treatment of relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy when ALL of the following criteria are met: 

  • Individual is 18 years of age or older; and
  • Documentation by clinician of at least one prior systemic therapy. 

National Comprehensive Cancer Network (NCCN) Recommendations

Mogamulizumab-kpkc (Poteligeo) may be considered medically necessary for ANY of the following conditions: 

  • Systemic therapy as primary treatment for: 
    • Stage IA MF with blood B1 involvement, with or without skin-directed therapy; or
    • Stage IB-IIA MF with blood B1 involvement, with or without skin-directed therapy; or
    • Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation therapy for: 
      • Limited tumor lesions; or
      • Generalized tumor lesions; or
    • Stage IIB MF with: 
      • Limited tumor lesions, with or without local radiation therapy; or
      • Generalized tumor lesions, with or without skin-directed therapy; or
    • Stage III MF with blood B1 involvement, with or without skin-directed therapy; or
    • Stage IV SS; or
  • Systemic therapy as treatment for: 
    • Stage IA MF with blood B1 involvement refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies, with or without skin-directed therapy; or
    • Stage IA MF refractory to multiple previous therapies or progression to > Stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation for limited tumor lesions; or
    • Stage IA MF refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies; with histologic evidence of folliculotropic or large-cell transformed MF, with or without skin-directed therapy for generalized tumor lesions; or
    • Stage IB-IIA MF refractory to multiple previous therapies or progression > stage IB-IIA; or
    • Stage IIB MF with limited tumor lesions that is relapsed with T3 limited extent disease or has persistent T3 limited extent disease, with or without local radiation therapy; or
    • Stage IIB MF with limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapies; or
    • Stage IIB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapy; or
    • Stage III MF with blood B1 involvement that is relapsed or persistent, with or without skin-directed therapy; or
    • Stage IV SS that is relapsed or persistent; or
  • Preferred second-line therapy with intention to proceed to high-dose therapy/allogeneic stem cell rescue (HDT/ASCR) or subsequent therapy to HDT/ASCR as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes. 

The use of mogamulizumab-kpkc (Poteligeo) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications. 

Procedure Codes 

J9204

   

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes

C84.00  C84.01  C84.02  C84.03  C84.04  C84.05  C84.06 
C84.07  C84.08  C84.09  C84.10  C84.11  C84.12  C84.13 
C84.14  C84.15  C85.16  C84.17  C84.18  C84.19  C91.50 
C91.52

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