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:
Mycosis Fungoides (MF)/Sezary Syndrome (SS)
- 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 a higher disease burden (e.g., predominantly plaque disease), with or without skin-directed therapy; 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 or without skin-directed therapy; or
- Stage IV SS, with or without skin-directed therapy; or
- Systemic therapy as treatment for:
- Stage IA MF with blood B1 involvement that is relapsed, persistent, or refractory to multiple previous therapies, with or without skin-directed therapy; or
- Relapsed or persistent stage IB-IIA MF with a higher disease burden (e.g., predominantly plaque disease), with or without skin-directed therapy; or
- Stage IIB MF with limited tumor lesions in EITHER of the following:
- Relapsed or persistent disease, with or without local radiation; or
- Refractory to multiple previous therapies, with or without skin-directed therapy; or
- Stage IIB MF relapsed or persistent disease with generalized tumor lesions, with or without skin-directed therapy; or
- Stage III MF that is EITHER of the following:
- Relapsed or persistent disease, with or without skin-directed therapy; or
- Refractory to multiple previous therapies, with or without skin-directed therapy; or
- Stage IV SS that is relapsed or persistent, with or without skin-directed therapy; or
- As second-line therapy or subsequent therapy 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
