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Last Review Date: 01/04/2024

Date of Origin: 06/24/2014

Dates Reviewed: 06/2014, 01/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 01/2019, 01/2020, 01/2021, 01/2022, 01/2023, 1/2024

1. Length of Authorization ^2,6

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

• Management of CAR T-Cell-Related Toxicities: Coverage will be provided for 1 dose only and may NOT be renewed

2. Dosing Limits

Quantity Limit (max daily dose) [NDC Unit]:

• Sylvant 100 mg single-dose vial: 3 vials per 21-day supply
• Sylvant 400 mg single-dose vial: 3 vials per 21-day supply

Max Units (per dose and over time) [HCPCS Unit]:

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient is human immunodeficiency virus (HIV) negative; AND
• Patient is human herpesvirus-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) † Ф ^1-4

Unicentric Castleman’s Disease (UCD) ‡ ²

• Used as second-line therapy for relapsed or refractory disease

Management of CAR T-Cell-Related Toxicities ‡ ^2,6

• Patient has received or will be receiving chimeric antigen receptor (CAR)-T cell therapy (e.g., axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, ciltacabtagene autoleucel, etc.); AND
  • Used for the management of Grade 4 cytokine release syndrome (CRS); AND
    • Patient is refractory to high-dose corticosteroids and anti-interleukin-6 therapy (e.g., tocilizumab); OR
  • Used as a replacement for the second dose of tocilizumab when supplies are limited or unavailable; AND
    • Used for Grade 1-4 CRS; OR
    • Used for Grade 1-4 neurotoxicity as additional therapy if the patient has concurrent CRS

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,2,6

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; 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 hypersensitivity, etc.

Management of CAR T-Cell-Related Toxicities

• May not be renewed

5. Dosage/Administration^1,3,4,6

6. Billing Code/Availability Information

HCPCS code:

• J2860 - Injection, siltuximab, 10 mg; 10 mg = 1 billable unit

NDC(s):

• Sylvant 100 mg lyophilized powder in a single-dose vial: 73090-0420-xx
• Sylvant 400 mg lyophilized powder in a single-dose vial: 73090-0421-xx

7. References

1. Sylvant [package insert]. Hemel Hempstead, Hertfordshire, U.K.; EUSA Pharma (UK), Ltd; December 2019. Accessed December 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for siltuximab. National Comprehensive Cancer Network, 2023. 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 2023.
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. Chen F, Teachey DT, Pequignot E, et al. Measuring IL-6 and sIL-6R in serum from patients treated with tocilizumab and/or siltuximab following CAR T cell therapy. J Immunol Methods. 2016 Jul;434:1-8. doi: 10.1016/j.jim.2016.03.005.
6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Management of Immunotherapy-Related Toxicities Version 1.2024. National Comprehensive Cancer Network, 2023. 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 Guidelines, go online to NCCN.org. Accessed December 2023.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A

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