BlueCross BlueShield of Tennessee Medical Policy Manual

Brentuximab Vedotin (Adcetris®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

• Classical Hodgkin Lymphoma (cHL)

• Treatment of adult patients with cHL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• Treatment of adult patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation
• Treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine
• Treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide

• Systemic anaplastic large cell lymphoma (sALCL)

• Treatment of adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
• Treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (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

• Treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) in patients who have received prior systemic therapy
• Treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product

Compendial Uses

• cHL stage I-II unfavorable
• CD30+ B-Cell Lymphomas

• Post-transplant lymphoproliferative disorders (B-cell type)
• Diffuse large B-cell lymphoma
• HIV-Related B-cell lymphomas
• High-grade B-Cell lymphomas
• Pediatric primary mediastinal large B-cell lymphoma

• CD30+ Primary Cutaneous Lymphomas

• Mycosis Fungoides (MF)/Sezary Syndrome (SS)
• Lymphomatoid papulosis (LyP)
• Cutaneous anaplastic large cell lymphoma

• CD30+ T-Cell Lymphomas

• Hepatosplenic T-cell lymphoma
• Adult T-cell leukemia/lymphoma
• Breast implant-associated anaplastic large cell lymphoma (ALCL)
• Peripheral T-cell lymphoma (PTCL)
• Extranodal NK/T-cell Lymphoma 
• Angioimmunoblastic T-cell lymphoma

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

Testing or analysis confirming CD30 expression on the surface of the cell (initial requests).

COVERAGE CRITERIA

Classic Hodgkin lymphoma (cHL)

Authorization of 12 months may be granted for treatment of CD30+ cHL when any of the following are met:

• The requested drug will be used as a single agent, or
• The requested drug will be used in combination with doxorubicin, vinblastine, and dacarbazine (BV + AVD), or
• The requested drug will be used in combination with bendamustine for re-induction or subsequent therapy, or
• The requested drug will be used in combination with dacarbazine, or
• The requested drug will be used in combination with nivolumab, or
• The requested drug will be used in combination with gemcitabine for re-induction or subsequent therapy, or
• The requested drug will be used in combination with ifosfamide, carboplatin and etoposide (ICE) for subsequent therapy, or
• The requested drug will be used in combination with etoposide, prednisone and doxorubicin (AEPA), or
• The requested drug will be used in combination with cyclophosphamide, prednisone, and dacarbazine (CAPDAC) for subsequent therapy, or
• The requested drug will be used in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide (Bv-AVE-PC), or
• The requested drug will be used in combination with cyclophosphamide, doxorubicin and prednisone (BV-CHP), or
• The requested drug will be used in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (BrECADD).

B-Cell Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ B-cell lymphomas with any of the following subtypes:

• Post-transplant lymphoproliferative disorders (B-cell type) as subsequent therapy.
• Diffuse large B-cell lymphoma as subsequent therapy.
• HIV-Related B-cell lymphomas (HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, human herpesvirus-8 (HHV8)-positive diffuse large B-cell lymphoma, or plasmablastic lymphoma) as subsequent therapy.
• Pediatric primary mediastinal large B-cell lymphoma when both of the following are met:

• The requested drug will be used for relapsed or refractory disease, and
• The requested drug will be used in combination with nivolumab or pembrolizumab

• High-grade B-cell lymphomas as subsequent therapy.

Primary Cutaneous Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ primary cutaneous lymphomas with any of the following subtypes:

• Mycosis fungoides (MF)/Sezary syndrome (SS)
• Lymphomatoid papulosis (LyP) when both of the following are met:

• The requested drug will be used as a single agent, and
• The disease is relapsed or refractory.

• Cutaneous anaplastic large cell lymphoma when either of the following are met:

• The requested drug will be used as a single agent, or
• The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

T-Cell Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ T-cell lymphomas with any of the following subtypes:

• Hepatosplenic T-cell lymphoma when the requested drug will be used as a single agent after two or more primary treatment regimens
• Adult T-cell leukemia/lymphoma when either of the following are met:

• The requested drug will be used as a single agent for subsequent therapy, or
• The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

• Breast implant associated anaplastic large cell lymphoma (ALCL) when either of the following are met:

• The requested drug will be used as a single agent, or
• The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

• Peripheral T-cell lymphoma (PTCL) [including the following subtypes: anaplastic large cell lymphoma, 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] when either of the following are met:

• The requested drug will be used as a single agent for subsequent or palliative therapy, or
• The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

• Extranodal NK/T-cell lymphoma when all of the following are met:

• The requested drug will be used as a single agent, and
• The member has relapsed or refractory disease, and
• The member has had an inadequate response or contraindication to asparaginase-based therapy (e.g., pegaspargase).

CONTINUATION OF THERAPY  

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

MEDICATION QUANTITY LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Adcetris [package insert]. Bothell, WA: Seagen, Inc.; February 2025.
2. The NCCN Drugs & Biologics Compendium^® © 2025 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed April 15, 2025. . 

ORIGINAL EFFECTIVE DATE: 9/6/2011

MOST RECENT REVIEW DATE: 1/30/2026

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.