57894-0420-XX - Sylvant 100 MG SOLR (JANSSEN BIOTECH)
57894-0421-XX - Sylvant 400 MG SOLR (JANSSEN BIOTECH)
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.
Siltuximab for the treatment of Castleman’s disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Siltuximab for the treatment of other conditions/diseases is considered investigational.
Siltuximab is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of Castleman’s disease (CD)
Individual is human immunodeficiency virus (HIV) negative
Individual is human herpes virus-8 (HHV-8) negative
Individual is currently free of all clinically significant infections
Individual will NOT receive ANY live vaccines while receiving treatment with this agent
Treatment is single agent therapy for ANY ONE of the following:
Multicentric Castleman’s Disease
Unicentric Castleman’s Disease as second-line therapy for relapsed or refractory disease
Siltuximab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent such as GI perforation and severe infusion related reactions (hypersensitivity), etc.
DOSAGE & ADMINISTRATION
11 mg/kg intravenously every 21 days
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Refer to DOSAGE LIMITS below
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).
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.
Lexicomp Online. (2018). AHFS DI. Siltuximab. Retrieved June 12, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, June). Siltuximab. Retrieved June 12, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Siltuximab. Retrieved June 12, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration, (2018, May). Center for Drug Evaluation and Research. Sylvant™ (siltuximab) for injection, for intravenous infusion. Retrieved June 11, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/14/2014
MOST RECENT REVIEW DATE: 8/14/2018
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 10 mg = 1 billable unit