BlueCross BlueShield of Tennessee Medical Policy Manual

Siltuximab

NDC CODE(S)

57894-0420-XX - Sylvant 100mg single use vial (Janssen Biotech, Inc)

 

57894-0421-XX - Sylvant 400mg single use vial (Janssen Biotech, Inc)

DESCRIPTION

Siltuximab is a monoclonal antibody that binds the cytokine interleukin-6 (IL-6).  This prevents IL-6 from binding to both soluble and membrane-bound IL-6 receptors.  IL-6 is involved in diverse physiological processes, including coordination of the immune response to infection.  When IL-6 is overproduced by cells within the lymph nodes it contributes to overgrowth of lymphatic cells and other systemic symptoms.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

11 mg/kg every 21 days

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).

A review of the published literature found no controlled studies that validate the use of siltuximab for the treatment of any other conditions or diseases

SOURCES

Lexicomp Online. (2016). AHFS DI. Siltuximab. Retrieved November 28, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, November). Siltuximab. Retrieved November 28, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Siltuximab. Retrieved November 28, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration, (2014, April). Center for Drug Evaluation and Research. Sylvant™ (siltuximab) for injection, for intravenous infusion. Retrieved November 28, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/14/2014

MOST RECENT REVIEW DATE:  12/1/2016

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

Siltuximab (Sylvant ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a diagnosis of Castleman’s Disease with absence of ALL of the following?

If yes, go to question #3

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

  1. Is there documentation the individual will not receive ANY live vaccines while receiving treatment with this agent?

If yes, go to question #4

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

  1. Is treatment single agent therapy for ANY ONE of the following?

If yes, go to question #5

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

  1. Is the request for 130 billable units every 21 days for dosage of 11 mg/kg every 21 days with an authorization period of six months and possible renewal?

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 5?

If yes, go to question #7

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

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #8

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

  1. Is there absence of unacceptable toxicity from the agent such as GI perforation, hyperuricemia and/or hematologic toxicity (neutropenia, thrombocytopenia) for which therapy should be interrupted?

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.