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.
Brentuximab vedotin (Adcetris) may be considered medical necessary for ANY ONE of the following indications:
Food and Drug Administration (FDA) Indications:
Classical Hodgkin Lymphoma (cHL)
- Brentuximab vedotin (Adcetris) is considered in previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine; or
- Brentuximab vedotin (Adcetris) is considered in cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation; or
- Brentuximab vedotin (Adcetris) is considered in cHL after failure of auto-HSCT or after failure of at least two prior multi agent chemotherapy regimens in patients who are not auto-HSCT candidates; or
Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL)
- Brentuximab vedotin (Adcetris) is considered in pcALCL or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy; or
Systemic Anaplastic Large Cell Lymphoma (sALCL)
- Brentuximab vedotin (Adcetris) is considered in previously untreated sALCL or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone; or
- Brentuximab vedotin (Adcetris) is considered in sALCL after failure of at least one prior multi-agent chemotherapy regimen; or
- Brentuximab vedotin (Adcetris) is considered in systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen; or
- Brentuximab vedotin (Adcetris) is considered in primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy; or
National Comprehensive Cancer Network (NCCN) Recommendations:
B-Cell Lymphomas- AIDS-Related B-Cell Lymphoma
- Second-line or subsequent therapy for relapse of CD30 positive AIDS-related diffuse large B-cell. Can be used for lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) in non-candidates for transplant; or
B-Cell Lymphomas-Diffuse Large B-Cell Lymphoma
- Second-line or subsequent therapy for CD30+ disease with partial response, no response, relapsed, progressive, or refractory in non-candidates for transplant; or
- When used in combination with nivolumab for relapsed or refractory primary mediastinal large B-cell lymphoma; or
B-Cell Lymphomas-Follicular Lymphoma (grade 1-2)
- Treatment of histologic transformation to CD30+ diffuse large B-cell lymphoma in individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease; or
B-Cell Lyphomas-High-Grade B-Cell Lymphomas
- Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory CD30+ disease in non-candidates for transplant; or
B-Cell Lymphomas-Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
- Treatment of histologic transformation to CD30+ diffuse large B-cell lymphoma in individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease; or
B-Cell Lymphomas-Post-Transplant Lymphoproliferative Disorders (PTLD)
- Second-line and subsequent therapy for individuals with partial response, persistent, or progressive disease after receiving chemoimmunotherapy as first-line treatment for CD30 positive monomorphic PTLD B-cell type; or
- Consider as treatment for CD30+ monomorphic PTLD (T-cell type) as a component of brentuximab + CHP (cyclophosphamide, doxorubicin, prednisone) regimen; or
Classical Hodgkin Lymphoma
- Primary treatment for individuals 18 years or older in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III-IV disease (useful in certain circumstances); or
- Second-line or subsequent systemic therapy for individuals 18 years or older (if not previously used) for relapsed or refractory disease:
- As a single agent; or
- In combination with bendamustine; or
- In combination with nivolumab; or
- Maintenance therapy following high-dose therapy (HDT) and autologous stem cell rescue (ASCR) for relapsed or refractory disease individuals 18 years or older with high risk* of relapse (if Deauville one (1)-three (3) prior to transplant or Deauville four (4) prior to transplant);or
- Primary treatment as a component of brentuximab vedotin followed by AVD (doxorubicin, vinblastine, dacarbazine) regimen conditionally followed by brentuximab vedotin in responding patients with a complete or partial response for stage I-II unfavorable or stage III-IV disease, for older individuals (age greater than 60); or
- Primary treatment in combination with dacarbazine for stage I-II unfavorable or stage III-IV disease, for older individuals (age greater than 60); or
- As palliative therapy as a single agent for relapsed or refractory disease in older individuals (age greater than 60); or
Primary Cuntaeous Lymphomas-Mycosis Fungoides (MF)/Sezary Syndrome (SS)
- 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 (eg, predominantly plaque disease), with or without skin-directed therapy; or
- Stage IIB MF with limited tumor lesions, with or without local radiation 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 IV Sezary syndrome; or
- 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 (eg, 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 Sezary syndrome, with or without skin-directed therapy; or
- Stage IV non-Sezary 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
- Preferred 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 (eg, predominantly plaque disease), with or without skin-directed therapy; or
- Relapsed or persistent stage IIB MF with limited tumor lesions, with or without local radiation therapy; or
- Stage IIB MF with limited tumor lesions refractory to multiple previous therapies, with or without skin-directed therapy; or
- Relapsed or persistent stage IIB MF with generalized tumor lesions, with or without skin-directed therapy; or
- Stage IIB MF with generalized tumor lesions refractory to multiple previous therapies
- 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 Sezary syndrome; or
- Relapsed or persistent stage IV non Sezary or visceral disease (solid organ), with or without radiation therapy for local control; 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
Primary Cutaneous Lymphomas-Primary Cutaneous CD30 Positive T-Cell Lymphoproliferative Disorders
- As a single-agent therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions or cutaneous ALCL with regional nodes (N1) (excludes systemic ALCL) as
- Primary treatment;or
- Therapy for relapsed or refractory disease,or
- Therapy for lymphomatoid papulosis (LyP) with extensive lesions as a single agent for relapsed/refractory disease following clinical trial, observation, retreatment with primary treatment, or treatment with alternative regimen not used for primary treatment; or
- Therapy for cutaneous anaplastic large cell lymphoma (ALCL) with regional node (N1) (excludes systemic ALCL) as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) for:
- Primary treatment; or
- Relapsed/refractory disease; or
T-Cell Lymphomas-Adult T-Cell Leukemia/Lymphoma
- Used as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) (**preferred) for CD30+ cases as;
- Chemotherapy in nonresponders to first-line therapy for chronic/smoldering subtype; or
- First-line therapy for acute subtype; or
- Continued treatment in responders to first-line therapy for acute subtype; or
- First-line therapy for lymphoma subtype; or
- Continued treatment in responders to first-line therapy for lymphoma subtype; or
- Preferred second-line or subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes (for CD30 expressing cases); or
T-Cell Lymphomas-Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)
- Adjuvant systemic therapy for localized disease to capsule/implant/breast following incomplete excision or partial capsulectomy with residual disease if node positive or radiation therapy is not feasible, or consider for extended disease (stage II-IV):
- As a single agent; or
- As a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone); or
T-Cell Lymphomas-Extranodal NK/T-Cell Lymphoma, nasal type
- Therapy as a single agent for CD30+ relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used; or
T-Cell Lymphomas-Hepatosplenic Gamma-Delta T-Cell Lymphoma
- Used as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) for CD30+ cases (useful under certain circumstances):
- As preferred primary treatment; or
- Consider as an alternate induction regimen if not used in primary treatment; or
- Preferred second-line and subsequent therapy as a single agent for CD30+ refractory disease after two (2) primary treatment regimens; or
T-Cell Lymphomas-Peripheral T-Cell Lymphomas
- As second-line or initial palliative intent therapy and subsequent therapy for relapsed or refractory systemic anaplastic large cell lymphoma CD30 positive peripheral T-cell lymphoma or CD30 positive angioimmunoblastic T-cell lymphoma; or
- Preferred first-line therapy for stage I, II ALK-positive anaplastic large cell lymphoma (ALCL) or ALK-negative ALCL with a DUSP22 rearrangement as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone); or
- Preferred first-line therapy for stage III, IV ALK-positive anaplastic large cell lymphoma (ALCL) or ALK-negative ALCL with a DUSP22 rearrangement as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone); or
- Preferred first-line therapy for CD30+ stage I-IV peripheral T-cell lymphoma not otherwise specified, ALK-negative anaplastic large cell lymphoma, 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, as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone); or
- Preferred second-line or initial palliative intent therapy and subsequent therapy for relapsed/refractory anaplastic large cell lymphoma, CD30+ peripheral T-cell lymphoma, or CD30+ angioimmunoblastic T-cell lymphoma, as a single agent.
The use of brentuximab vedotin (Adcetris)is considered experimental/investigational and therefore non-covered for any other indications. Scientific evidence does not support the use for all other indications.
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