Pralatrexate (Folotyn^TM) is a cytotoxic neoplastic agent, which acts as a folate analogue metabolic inhibitor leading to interruption of DNA synthesis. It competitively inhibits dihydrofolate reductase, and is a competitive inhibitor for polyglutamylation via the folylpolyglutamyl synthetase enzyme. This results in thymidine and other biological molecule depletion, the synthesis of which depends on single carbon transfer.

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) Indications

• Adult T-Cell Leukemia/Lymphoma as:
  • Second-line or subsequent therapy as a single agent for nonresponders to first-line therapy for acute disease or lymphoma subtypes; or
• Extranodal NK/T-cell lymphoma, nasal type
  • Single agent for relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used (preferred); or
• Hepatosplenic gamma-delta T-cell lymphoma
  • Second-line and subsequent therapy as a single agent for refractory disease after two (2) primary treatment regimens (preferred); or
• Mycosis Fungoides (MF)/Sézary syndrome (SS) 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 (preferred); or
  • Stage III MF with or without skin-directed therapy; or
  • Stage IV non-Sézary or visceral disease (solid organ) with or without radiation therapy for local control (preferred); or
  • Large cell transformation (LCT) with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy (preferred); or

• MF/SS as systemic therapy as treatment for:
  • Stage IA MF with B1 blood 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 refractory to multiple previous therapies, with or without skin-directed therapy (preferred); or
  • Relapsed or persistent stage IIB MF with generalized tumor lesions, with or without skin-directed therapy (preferred); 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 IV SS; or
  • Relapsed or persistent stage IV non-Sézary or visceral disease (solid organ), with or without radiation therapy for local control (preferred); or
  • Large cell transformation (LCT) with limited cutaneous lesions that is refractory to multiple previous therapies (preferred); or
  • Relapsed or persistent LCT with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy (preferred); or

• Peripheral T-cell lymphoma as second-line or 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
  • Relapsed or refractory anaplastic large cell lymphoma; 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 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
  • 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

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

Professional Statements and Societal Positions Guidelines

NA