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.
INITIAL APPROVAL CRITERIA
Patient is at least 18 years of age;AND
Patient is human immunodeficiency virus (HIV) negative; AND
Patient is human herpes virus-8 (HHV-8) negative; AND
Patient is currently free of all clinically significant active infections; AND
Patient will NOT receive any live vaccines during treatment with siltuximab; AND
Must be used as a single agent; AND
Multicentric Castleman’s Disease (MCD)
Unicentric Castleman’s Disease (UCD)
Must be used second-line therapy for relapsed or refractory disease; AND
Patient has plasmacytic/mixed histology
Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in initial approval criteria; AND
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: gastrointestinal perforation, severe infusion related reactions and severe hypersensitivity, etc.
DOSAGE & ADMINISTRATION
Administer 11 mg/kg intravenously every 21 days until treatment failure
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Max Units (per dose and over time) [HCPCS Unit]:
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).
1. Sylvant [package insert]. Hemel Hempstead, Hertfordshire, U.K.; EUSA Pharma (UK), Ltd; December 2019. Accessed December 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for siltuximab. National Comprehensive Cancer Network, 2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2020.
3. van Rhee F, Wong RS, Munshi N, et al. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. doi: 10.1016/S1470-2045(14)70319-5. Epub 2014 Jul 17.
4. Kurzrock R, Voorhees PM, Casper C, et al. A phase I, open-label study of siltuximab, an anti-IL-6 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma, multiple myeloma, or Castleman disease. Clin Cancer Res. 2013 Jul 1;19(13):3659-70. doi: 10.1158/1078-0432.CCR-12-3349. Epub 2013 May 9.
5. Lexicomp Online. (2020, March). AHFS DI. Siltuximab. Retrieved January 20, 2021 from Lexicomp Online with AHFS.
6. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, December). Siltuximab. Retrieved January 20, 2021 from MICROMEDEX Healthcare Series.
ORIGINAL EFFECTIVE DATE: 6/14/2014
MOST RECENT REVIEW DATE: 6/2/2021
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.
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