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.
Pralatrexate (Folotyn) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indications
- For the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL); or
National Comprehensive Cancer Network (NCCN) Recommendations
Adult T-Cell Leukemia/Lymphoma
- Used as second-line or subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes; or
Extranodal NK/T-cell lymphoma, nasal type
- Used as single agent for relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used; or
Hepatosplenic gamma-delta T-cell lymphoma
- Used as single agent for refractory disease after two (2) first-line therapy regimens (preferred); or
Mycosis Fungoides (MF)/Sézary syndrome (SS)
- Used as preferred** systemic therapy as primary treatment for
- Stage IA MF with B1 blood involvement, with or without skin-directed therapy; or
- Stage IB-IIA MF with a higher disease burden (e.g., predominantly plaque disease) and B1 blood involvement, with or without skin-directed therapy; or
- Stage IIB MF with generalized tumor lesions, with or without skin-directed therapy; or
- Stage III MF with or without skin-directed therapy; or
- Stage IVA1 or IVA2 Sezary syndrome, with or without skin-directed therapy
- Stage IVA2 non-Sézary or stage IVB visceral disease (solid organ) with or without radiation therapy for local control; or
- Large cell transformation (LCT) with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy; or
- Used as preferred systemic therapy as subsequent treatment for:
- Relapsed or persistent stage IA mycosis fungoides (MF) with T1 skin disease and B1 blood involvement, with or without skin-directed therapy; or
- Stage IB-IIA MF with a higher skin disease burden (eg, predominantly plaque disease) and B1 blood involvement that is relapsed or persistent with T1-T2 disease, with or without skin-directed therapy; or
- Relapsed stage IIB MF with T3 generalized tumor lesions, with or without skin-directed therapy; or
- Persistent stage IIB MF with T1-3 generalized tumor lesions, with or without skin-directed therapy; or
- Stage IIB MF with generalized tumor lesions refractory to multiple previous therapies; or
- Relapsed or persistent stage III MF, with or without skin-directed therapy; or
- Stage III MF that is refractory to multiple previous therapies; or
- Relapsed or persistent stage IVA1 or IVA2 Sezary syndrome; or
- Stage IVA1 or IVA2 Sezary syndrome that is refractory to multiple previous therapies; or
- Relapsed or persistent stage IVA2 non-Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control; or
- Stage IVA2 non-Sezary or stage IVB visceral disease (solid organ) that is refractory to multiple previous therapies; or
- Large cell transformation (LCT) with limited cutaneous lesions that is refractory to multiple previous therapies; or
- Relapsed or persistent LCT with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy; or
- LCT with generalized cutaneous or extracutaneous lesions that is refractory to multiple previous therapies; or
Peripheral T-cell lymphoma
- Used as second-line or initial palliative intent therapy and subsequent therapy for relapsed or refractory:
- Anaplastic large cell lymphoma; or
- Angioimmunoblastic T-cell lymphoma; or
- Peripheral T-cell lymphoma not otherwise specified (preferred**); or
- Enteropathy-associated T-cell lymphoma (preferred**); or
- Monomorphic epitheliotropic intestinal T-cell lymphoma (preferred**); or
- Nodal peripheral T-cell lymphoma with TFH phenotype (preferred**); or
- Follicular T-cell lymphoma (preferred**), as a single agent; or
Primary cutaneous CD30+ T-Cell lymphoproliferative disorders
- Used as therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional nodes (excludes systemic ALCL), as a single agent for EITHER of the following:
- Primary treatment; or
- Relapsed/refractory disease.
The use of pralatrexate (Folotyn) for any other indication is considered experimental/investigational and therefore, not covered. Scientific evidence does not support its use for any other indications.
Procedure Codes
