Siltuximab (Sylvant)

Policy ID: I-170-005

Section: Injections

Effective Date: February 01, 2020

Revised Date: May 17, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: May 24, 2022

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 multi-centric 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.

Siltuximab (Sylvant) may be considered medically necessary for individuals 18 years of age or older when ALL of the following criteria are met:

Treatment of individual with multi-centric 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; or

Compendia Sources

Siltuximab (Sylvant) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of siltuximab (Sylvant) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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

D47.Z2

D89.831

D89.832

D89.833

D89.834

D89.839

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

Internal Medical Policy Committee 5-24-2022 Removed NCCN recommendations and added this statement "Siltuximab (Sylvant) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.", updated the experimental/investigational statement, updated dx codes

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.

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

Archived Date: June 30, 2022

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.

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

Diagnosis Codes

D36.0

D47.Z2

R59.0

R59.1

R59.9