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Siltuximab (Sylvant)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020

Description

Siltuximab (Sylvant®) is an interleukin-6 (IL-6) antagonist indicated for the treatment of individuals with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Food and Drug Administration (FDA) Indication

Siltuximab (Sylvant) may be considered medically necessary for the treatment of individuals 18 years of age and older with Multicentric Castleman disease (MCD) when ALL of the following criteria are met:

  • Individual is human immunodeficiency virus-negative and human herpesvirus-8-negative; and
  • Individual does not have organ failure; and
  • No concurrent clinically significant infection (for example, Hepatitis B or C); and
  • No concurrent lymphoma; and
  • Individuals must have hematology laboratory tests prior to first siltuximab (Sylvant) dose showing the following absolute neutrophil count: greater than or equal to 1.0 x109/L; and
  • Individuals whose platelet count: greater than or equal to 75 x109/L; and
  • Individuals whose hemoglobin less than or equal to 17g/dL.

 

National Comprehensive Cancer Network (NCCN) Indication:

Siltuximab (Sylvant) may be considered medically necessary for the following:

  • Unicentric Castleman disease (UCD):
    • When used as second-line therapy as a single agent for relapsed or refractory UCD for individuals who are human immunodeficiency virus-negative and human herpesvirus-8-negative; or
  • Multicentric Castleman’s Disease (MCD)
    • When used as a single-agent therapy for active MCD with no organ failure for individuals who are human immunodeficiency virus-negative and human herpes-virus-8-negative, when used as any of the following:
      • When used as a primary treatment; or
      • When used for relapsed disease; or
      • When no response to primary treatment.

Siltuximab (Sylvant) is considered experimental/investigational for any other indication and therefore non-covered.  Scientific evidence does not support its use for any other indications.

Procedure Codes

J2860

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

 

Covered Diagnosis Codes

D36.0 D47.Z2 R59.0 R59.1 R59.9

Professional Statements and Societal Positions Guidelines

NA

Links