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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All Indications 1.8 mg/kg (up to 180 mg) infused every 3 weeks

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 

No controlled studies were found in the published literature that validate the use of brentuximab vedotin for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2017, March). AHFS DI. Brentuximab vedotin. Retrieved March 30, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, February). Brentuximab vedotin. Retrieved March 30, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Brentuximab vedotin. Retrieved March 30, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, September). Center for Drug Evaluation and Research. Adcetris® (brentuximab vedotin) for injection, for intravenous use. Retrieved March 30, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/6/2011

MOST RECENT REVIEW DATE:  6/6/2017

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.

Pharmaceutical Decision Support Tree

Brentuximab Vedotin (Adcetris ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #15

  1. Is the individual 18 years of age with CD30-positive disease and NOT receiving concomitant bleomycin therapy?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of Hodgkin Lymphoma diagnosed as classical disease (cHL)?

If yes, go to question #4

If no, go to question #8

  1. Is the request for treatment as a single agent for ANY ONE of the following?

If yes, go to question #14

If no, go to question #5

  1. Is the request for use as second-line therapy prior to high-dose therapy with autologous stem cell rescue (HDT-ASCR) to minimize use of more intensive chemotherapy?

If yes, go to question #14

If no, go to question #6

  1. Is the request for treatment as a single agent for maintenance therapy if ALL of the following?

If yes, go to question #14

If no, go to question #7

  1. Is the request for palliative therapy as a single agent for an individual older than 60 years of age?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a diagnosis of Non-Hodgkin Lymphoma?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the NHL further classified as Adult T-Cell Leukemia/Lymphoma requesting single agent therapy for ANY ONE of the following?

If yes, go to question #14

If no, go to question #10

  1. Is the NHL further classified as Breast Implant-Associated Anaplastic Large Cell Lymphoma if ANY ONE of the following?

If yes, go to question #14

If no, go to question #11

  1. Is the NHL further classified as Mycosis Fungoides (MF)/Sézary Syndrome (SS) as first-line therapy for disease diagnosed as ANY ONE of the following?

If yes, go to question #14

If no, go to question #12

  1. Is the NHL further classified as Peripheral T-cell Lymphoma (PTCL) if individual has failed at least 1 prior multi-agent chemotherapy regimen for relapsed or refractory systemic anaplastic large cell lymphoma (sALCL), CD30+peripheral T-cell lymphoma or angioimmunoblastic T-Cell Lymphoma?

If yes, go to question #14

If no, go to question #13

  1. Is the NHL further classified as Primary Cutaneous T-Cell Lymphoproliferative Disorder if the request is for ANY ONE of the following?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 200 billable units or less per 21 days for dosage of 1.8 mg/kg (up to 180 mg) infused every 3 weeks up to 6 months authorization period (up to a maximum treatment of 16 cycles for Hodgkin Lymphoma post autologous stem cell transplant)

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet initial approval criteria in questions 2 through 14?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response evident as defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms?

If yes, go to question #17

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity from the agent, e.g., neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, peripheral motor neuropathy, vomiting, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.