Siltuximab (Sylvant)

Policy ID: I-170-004

Section: Injections

Effective Date: February 01, 2020

Revised Date: November 03, 2020

Revision Effective Date: January 01, 2021

Last Reviewed: November 23, 2021

Applies To: Commercial and Medicaid Expansion

Description

Siltuximab (Sylvant®) is an interleukin-6 (IL-6) antagonist.It binds to human IL-6 and prevents the binding of IL-6 to both soluble and membrane-bound IL-6 receptors. IL-6 has been shown to be involved in diverse normal and physiologic processes such as induction of immunoglobulin secretion. Overproduction of IL-6 has been linked to systemic manifestations of multicentric Castleman’s Disease (CD).

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 individuals 18 years of age or older for any of the following indications:

Treatment of individual with multicentric Castleman’s disease (CD) who is human immunodeficiency virus-negative and human herpesvirus-8 (HHV-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
Individualsmust 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 platelet count is greater than or equal to 75 x10⁹/L; and
Individuals hemoglobin is less than or equal to 17g/dL; or

National Comprehensive Cancer Network (NCCN) Recommendations

B-Cell Lymphomas – Castleman’s Disease (CD)

Second-line therapy as a single agent for relapsed or refractory unicentric CD for individuals with plasmacytic/mixed histology who are human immunodeficiency virus-negative and human herpesvirus-8-negative; or
Single-agent therapy for active idiopathic multicentric CD with no organ failure for individuals with plasmacytic/mixed histology who are human immunodeficiency virus-negative and human herpes-virus-8-negative, when used as any of the following:
- As primary treatment; or
- As alternate treatment for relapsed disease; or
- If 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.

Diagnosis Codes

D36.0

D47.Z2

R59.0

R59.1

R59.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Adopt new pre-certification policy

Internal Medical Policy Committee 11-19-2020 Description updated, minor wording changes, no clinical content change

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Section: Injections

Effective Date: February 01, 2020

Revised Date: January 27, 2020

Last Reviewed: January 22, 2020

Archived Date: December 31, 2020

Applies To: Commercial Only

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.

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

Not Applicable

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