CurrentViva HealthPolicy IC-0200

Sylvant (siltuximab) coverage

Policy governing prior authorization, coverage criteria, dosing, and coding for intravenous siltuximab (Sylvant) for Viva Health members, including indications like multicentric and unicentric Castleman's disease and management of CAR T-cell–related toxicities.

Policy Summary

PayerViva Health

PolicySylvant (siltuximab) coverage

Policy CodePolicy IC-0200

Change TypeNo material change

Effective DateMar 4, 2025

Next Review DateMar 4, 2025

Key ActionObtain prior authorization and document age ≥18, HIV/HHV-8 negative status, absence of active infections, and appropriate diagnosis to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsstandard initial authorization length

11 mg/kgrecommended dose

J2860HCPCS code

130max billable units

≥18min patient age

Coverage Criteria for Siltuximab (Sylvant)

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Initial Therapy — Covered when ALL of the following are met for the selected indication

Covered when ALL of the following are met for the selected indication

Universal eligibility: Patient is at least 18 years of age; Patient is HIV-negative; Patient is HHV-8 negative; Patient is currently free of all clinically significant active infections; Patient will NOT receive any live vaccines during treatment with siltuximab; Siltuximab must be used as a single agent.

From Universal Criteria (policy section III/Universal Criteria)

Indication-specific criteria: One of the following indications must be documented: (1) Multicentric Castleman's Disease (MCD) — FDA approved; (2) Unicentric Castleman's Disease (UCD) — used as subsequent therapy for relapsed/refractory or progressive unresectable disease; (3) Management of CAR T-Cell–Related Toxicities per criteria below.

Indications listed in policy

CAR T-cell–related toxicity specifics: Patient has received or will be receiving CAR-T cell therapy; AND one of the following CAR T-related uses is met: (a) Used for management of Grade 4 cytokine release syndrome (CRS) when patient is refractory to high-dose corticosteroids and anti-IL-6 therapy (e.g., tocilizumab); OR (b) Used as a replacement for the second dose of tocilizumab when supplies are limited or unavailable for Grade 1-4 CRS; OR (c) Used for Grade 1-4 neurotoxicity as additional therapy if the patient has concurrent CRS.

From Management of CAR T-Cell-Related Toxicities section

Continuation/Renewal Therapy — Covered when ALL of the following are met for renewal

Covered when ALL of the following are met for renewal

Renewal requirements: Patient continues to meet the universal and indication-specific criteria; Duration of prior authorization has not been exceeded (see Length of Authorization); Disease response demonstrated by stabilization of disease or decrease in tumor size or spread; Absence of unacceptable toxicity from siltuximab (examples include gastrointestinal perforation, severe infusion-related reactions, hypersensitivity).

From Renewal Criteria (policy section IV) and Length of Authorization

Coverage is excluded for patients who do not meet the policy's Universal Criteria. Specifically, the patient must be HIV‑negative and HHV‑8‑negative, and must be currently free of all clinically significant active infections. Failure to document these negative viral statuses or presence of active infection may render the request ineligible for coverage.

Administration of live vaccines is not allowed during siltuximab therapy. The policy requires that the patient will NOT receive any live vaccines during treatment with siltuximab; concomitant live vaccination is therefore an exclusion to coverage.

Regimen	Indication	Coverage
11 mg/kg IV every 21 days until treatment failure
Multicentric Castleman's disease (MCD); Unicentric Castleman's disease (UCD)
Covered with criteria (see policy for universal and indication-specific requirements)

Regimen	Indication	Coverage
11 mg/kg IV one time only
Management of CAR T-cell–related toxicities (per policy criteria)
Covered with criteria (used after/replacement for tocilizumab or for refractory severe CRS/CRS with neurotoxicity per criteria)

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J2860

Injection, siltuximab, 10 mg; 10 mg = 1 billable unit

NDCsNDC

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

Covered Diagnosis CodesICD-10Covered

D47.Z2	Castleman disease
D89.831	Cytokine release syndrome, grade 1
D89.832	Cytokine release syndrome, grade 2
D89.833	Cytokine release syndrome, grade 3
D89.834	Cytokine release syndrome, grade 4
D89.839	Cytokine release syndrome, grade unspecified
G92.00	Immune effector cell-associated neurotoxicity syndrome, grade unspecified
G92.01	Immune effector cell-associated neurotoxicity syndrome, grade 1
G92.02	Immune effector cell-associated neurotoxicity syndrome, grade 2
G92.03	Immune effector cell-associated neurotoxicity syndrome, grade 3

1–10 of 15

1/2

HCPCS billable unit interval — MCD/UCD

MCD/UCD billable units130 units per HCPCS entry

Interval (MCD/UCD)21 days between administrations

Management of immunotherapy-related toxicities units130 units per HCPCS entry

Interval (CAR T-related toxicities)One course of therapy only (single administration interval)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Coverage is provided when all clinical criteria are met and documentation is submitted as outlined below.

Prior authorization required prior to initiation of therapy.

Documentation Required

Eligibility and Safety Documentation

Document the following to support eligibility and safety: patient age, HIV and HHV-8 negative status, absence of clinically significant active infections, and that the patient is not expected to receive live vaccines during treatment. Also document absence of unacceptable risk for therapy.

Document patient age (≥ 18 years when applicable).
Document HIV-negative and HHV-8-negative test results or clinical evidence.
Document absence of clinically significant active infections.
Document that live vaccines will not be administered during treatment.
Document assessment of unacceptable toxicity risk and rationale for treatment decision.

Step Therapy

Prerequisite Therapies and CAR T–Related Use

For CAR T‑cell–related use, document prior therapies and specific clinical circumstances: confirm receipt of CAR‑T therapy, grade of cytokine release syndrome (CRS) or neurotoxicity, and that the patient is refractory to prerequisite therapies when indicated. If used for CRS management, document failure or refractoriness to high‑dose corticosteroids and anti–IL‑6 therapy (e.g., tocilizumab) before use for refractory Grade 4 CRS. If used as replacement for a second tocilizumab dose due to supply limitations, document the supply issue and the grade of CRS or concurrent neurotoxicity.

Confirm patient has received or will receive CAR‑T cell therapy.
For Grade 4 CRS management: document refractoriness to high‑dose corticosteroids AND anti‑IL‑6 therapy (e.g., tocilizumab).
If used as replacement for second tocilizumab dose: document limited/unavailable tocilizumab supply and indication (Grade 1–4 CRS or Grade 1–4 neurotoxicity with concurrent CRS).
Document grade of CRS or neurotoxicity and prior interventions attempted.

Definitions

Cytokine release syndrome (CRS)

CRS gradingCRS grades 1–4 as listed in policy (use NCCN guidance for grade definitions)

ICD-10 codes for CRS (grade-specific)D89.831 (grade 1); D89.832 (grade 2); D89.833 (grade 3); D89.834 (grade 4); D89.839 (grade unspecified)

Context for useSiltuximab may be used for management of Grade 4 CRS refractory to steroids and anti-IL-6 therapy, or as replacement for second tocilizumab dose when supplies limited (per CAR T-cell toxicity criteria)

Immune effector cell-associated neurotoxicity syndrome (ICANS)

ICANS grade-specific codesG92.01 (grade 1); G92.02 (grade 2); G92.03 (grade 3); G92.04 (grade 4); G92.00 (grade unspecified)

Related complication codesT80.82XA, T80.82XS, T80.89XA, T80.89XS — complications of immune effector cellular therapy or other infusion-related complications

Clinical contextICANS coverage applies when used as additional therapy for neurotoxicity concurrent with CRS in CAR T-cell recipients (per CAR T-cell toxicity criteria)

OpenPayer

Sylvant (siltuximab) coverage

Coverage Criteria for Siltuximab (Sylvant)

Billing and Coding

Provider Actions and Documentation Requirements

Line of Therapy

Definitions

Background

Revision History