51144-0050-XX Adcetris 50 MG SOLR (SEATTLE GENETICS)
Brentuximab vedotin is an antibody-drug conjugate (ADC). ADCs consist of three parts, a monoclonal antibody, a linker and a cytotoxic agent. Together these three parts function as more specifically targeted therapy and potentiate a greater effect on the target cells. The components of brentuximab vedotin consist of the chimeric IgG1 antibody cAC10 specific for the CD30 antigen, a protease-cleavable linker and the microtubule disrupting agent MMAE.
The anticancer activity of brentuximab vedotin likely begins with the binding of the antibody cAC10 to cells expressing the CD30 antigen. The entire ADC-CD30 complex is then internalized in the cell where the MMAE is released. The MMAE then binds to tubulin which disrupts the microtubule network inducing cell cycle arrest and apoptotic death of the cell.
Brentuximab vedotin for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Brentuximab vedotin for the treatment of other conditions/diseases is considered investigational.
Brentuximab vedotin is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Disease is CD30-positive
Individual must NOT be receiving concomitant bleomycin
Diagnosis of ANY ONE of the following:
Hodgkin Lymphoma (HL) that is further diagnosed as classical HL (cHL) for ANY ONE of the following:
Used as single agent therapy for ANY ONE of the following:
Post-autologous hematopoietic stem cell transplant consolidation (auto-HSCT) in individual at high risk for relapse or progression
Individual with relapsed disease after failure of auto-HSCT or at least 2 prior multi-agent chemotherapy regimens who are not auto-HSCT candidates
Subsequent systemic therapy for relapsed or refractory disease
Maintenance therapy following high-dose therapy and autologous stem cell rescue (HDT/ASCR) for relapsed or refractory disease with high risk for relapse
Used in combinations with cytotoxic chemotherapy as subsequent systemic therapy for relapsed or refractory disease
Used in combination with doxorubicin, vinblastine, and dacarbazine as initial therapy for previously untreated Stage III or IV disease
Non-Hodgkin lymphoma (NHL) for ANY ONE of the following:
Used as single agent for relapsed or refractory disease as subsequent therapy for ANY ONE of the following:
Systemic Anaplastic Large Cell Lymphoma (sALCL)
Peripheral T-Cell Lymphoma (PTCL)
Angioimmunoblastic T-cell Lymphoma (ATCL)
Used in combination with cyclophosphamide, doxorubicin, and prednisone as initial therapy for previous untreated disease for ANY ONE of the following:
Systemic Anaplastic Large Cell Lymphoma (sALCL) †
Peripheral T-Cell Lymphoma (PTCL) †
Angioimmunoblastic T-cell Lymphoma (ATCL)
Enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, or follicular T-cell lymphoma
Adult T-Cell Leukemia/Lymphoma for ANY ONE of the following:
Used as single agent therapy for acute disease or lymphoma as subsequent therapy for nonresponders to first-line therapy
Used as a component of CHP (cyclophosphamide, doxorubicin, prednisone) for ANY ONE of the following:
Used for acute disease or lymphoma
Used subsequent therapy for non-responders to first-line therapy
Breast Implant-Associated Anaplastic Large Cell Lymphoma for ALL of the following:
Used as single agent or in combination with CHP (cyclophosphamide, doxorubicin, prednisone) for adjuvant therapy of localized disease to the capsule or implant or breast
Individual had incomplete excision or partial capsulectomy with residual or extended disease
Extranodal NK/T-Cell Lymphoma for ALL of the following:
Individual has nasal type disease;
Used as a single agent preferred therapy for relapsed refractory disease
Used after previous asparaginase based chemotherapy regimen if not previously used
Hepatosplenic Gamma-Delta T-Cell Lymphoma for ANY ONE of the following:
Used as single-agent therapy for refractory disease as subsequent therapy after progression on two primary treatment regimens
Used as a component of CHP (cyclophosphamide, doxorubicin, prednisone) as preferred primary treatment or as an alternate induction regimen if not used during primary treatment
Mycosis Fungoides (MF)/Sézary Syndrome (SS)
Primary cutaneous CD30+ T-cell lymphoproliferative disorder for ANY ONE of the following:
Used as a single agent if ANY ONE of the following:
Primary cutaneous anaplastic large cell lymphoma (pcALCL)
Cutaneous ALCL with regional nodes (excludes systemic ALCL)
Lymphomatoid papulosis (LyP) relapsed or refractory to all treatment options
Used as a component of CHP (cyclophosphamide, doxorubicin, prednisone) and individual has cutaneous ALCL with regional nodes (excludes systemic ALCL)
B-Cell Lymphomas for ANY ONE of the following:
Used for histologic transformation of follicular lymphoma or marginal zone lymphoma to Diffuse Large B-Cell Lymphoma (DLBCL) in individuals who have received multiple lines of therapy for transformed or indolent disease
Individual is not a candidate for transplant and ANY ONE of the following:
Used as subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease and individual has ANY ONE of the following:
Primary Cutaneous DLBCL
High grade B-cell lymphoma
Used as subsequent therapy for relapse of AIDS-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL
Used as subsequent therapy for individuals with partial response, persistent or progressive disease after receiving chemoimmunotherapy as first-line treatment for CD30+ monomorphic PTLD (B-cell type)
Brentuximab vedotin is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response with treatment defined by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent, e.g., progressive multifocal leukoencephalopathy, peripheral neuropathy, anaphylaxis and infusion reactions, hematologic toxicities (thrombocytopenia, neutropenia and anemia),serious infections, tumor lysis syndrome, increased toxicity in patients with severe renal (CrCl < 30 ml/min) and hepatic impairment (Child-Pugh B or C), hepatotoxicity, pulmonary toxicity, serious dermatologic reactions, gastrointestinal complications, etc.
DOSAGE & ADMINISTRATION
Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
1.2 mg/kg (up to 120 mg) by intravenous infusion every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity
cHL post-auto HSCT, MF/SS, Primary cutaneous CD30+ T Cell Lymphoproliferative Disorders
1.8 mg/kg (up to 180 mg) by intravenous infusion every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity
Previously Untreated sALCL or Other CD30-expressing PTCL
1.8 mg/kg (up to 180 mg) by intravenous infusion every 3 weeks with each cycle of chemotherapy for a maximum of 6 to 8 doses
Breast-Implant Associated Anaplastic Large Cell Lymphoma (ALCL)
1.8 mg/kg (up to 180 mg) by intravenous infusion every 3 weeks until a maximum of 6 cycles, disease progression, or unacceptable toxicity
All other indications
1.8 mg/kg (up to 180 mg) by intravenous infusion every 3 weeks until disease progression or unacceptable toxicity
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Treatment for cHL post-auto HSCT, primary cutaneous anaplastic large cell lymphoma (pcALCL), Mycosis Fungoides (MG)/Sezary Syndrome (SS) and Primary cutaneous CD30+ T Cell Lymphoproliferative Disorders has a maximum of 16 cycles.
Treatment of previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL) has a maximum of 12 doses.
Treatment of previously untreated Systemic Anaplastic Large Cell Lymphoma (sALCL) or other CD30-expressing Peripheral T-Cell Lymphomas (PTCL) has a maximum of 8 doses
Treatment of Breast-Implant Associated Anaplastic Large Cell Lymphoma (ALCL) has a maximum of 6 cycles as adjuvant therapy.
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.
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, the express terms of the health plan will govern.
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).
Lexi-Comp Online. (2018, February). AHFS DI. Brentuximab vedotin. Retrieved January 23, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Brentuximab vedotin. Retrieved January 23, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Brentuximab vedotin. Retrieved January 23, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, November) Center for Drug Evaluation and Research. Adcetris® (brentuximab vedotin) for injection, for intravenous use. Retrieved January 23, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s088lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/6/2011
MOST RECENT REVIEW DATE: 6/30/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 1 mg