BlueCross BlueShield of Tennessee Medical Policy Manual

Brentuximab Vedotin

NDC CODE(S)

51144-0050-XX Adcetris 50 MG SOLR (SEATTLE GENETICS)

DESCRIPTION

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.   

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

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.

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, the express terms of the health plan will govern.

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).

SOURCES  

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

ID_MRx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit   1 billable unit = 1 mg

DIAGNOSIS

MAXIMUM UNITS

All Indications

200 billable units per 21 days