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.
Belinostat (Beleodaq) may be considered medically necessary for ANY of the following conditions:
Food and Drug Administration (FDA) Indications:
Peripheral T-Cell Lymphoma
- As treatment of individuals 18 years of age and older with relapsed or refractory peripheral T-cell lymphoma; or
National Comprehensive Cancer Network (NCCN) Recommendations
Primary Cutaneous Lymphomas:
Mycosis Fungoides (MF)/Sezary Syndrome (SS)
- As primary systemic therapy for ANY of the following:
- Stage IV non-Sezary or visceral disease, 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
- As systemic therapy for ANY of the following:
- Relapsed or persistent stage IA MF with B1 blood involvement, with or without skin-directed therapy; or
- Relapsed or persistent stage IB-IIA MF with B1 blood involvement, 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; or
- Relapsed or refractory stage IIB MF with generalized tumor lesions, with or without skin-directed therapies; or
- Stage IIB MF with generalized tumor lesions that is refractory to multiple previous therapies or progression; or
- Relapsed or persistent stage III MF, with or without skin-directed therapies; 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-Sezary or visceral disease, with or without radiation therapy for local control; or
- 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 therapies; 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 node (N1) as a single agent for relapsed or refractory disease; or
T-Cell Lymphomas:
Adult T-Cell Leukemia/Lymphoma
- 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
- As single agent therapy 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
- As second-line and subsequent therapy as a single agent for refractory disease after 2 primary treatment regimens; or
Peripheral T-Cell Lymphomas
- As second-line or initial palliative intent therapy and subsequent therapy as a single agent for relapsed/refractory ALCL, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, or follicular T-cell lymphoma.
The use of belinostat (Beleodaq) for all other indications is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use for all other indications.
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