CurrentHealth NetPolicy CP PHAR.329

Clinical Policy: Siltuximab (Sylvant)

Clinical coverage policy for siltuximab (Sylvant) detailing initial and continued therapy criteria for multicentric Castleman's disease (MCD), off-label use for unicentric Castleman's disease (UCD) and cytokine release syndrome (CRS), contraindications, dosing limits, required documentation, and coding implications for Health Net / Centene lines of business (HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Siltuximab (Sylvant)

Policy CodePolicy CP PHAR.329

Change TypeAdded/Updated criteria (material and non-material)

Effective DateMar 1, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added NCCN-supported use for CRS to allow Sylvant as replacement for second dose of Actemra or Tofidence; later added Tyenne and Carvykti examples.

Lab parameters removed from criteria sets as they do not represent treatment contraindication.

Added criteria set for NCCN compendium-supported use for CRS associated with CAR or autologous T cell therapy.

Minor template and reference updates with no significant clinical policy changes in 1Q2023 review.

1FDA approved indications (MCD HIV-/HHV-8-)

2Off-label indications referenced (UCD, CRS)

11 mg/kgMaximum recommended dose

4Max CRS doses (continued therapy)

Coverage Summary

Policy stance: covered with criteria for on-label multicentric Castleman's disease (MCD) in patients who are HIV negative and HHV-8 negative, and for select NCCN-supported off‑label uses (unicentric Castleman's disease [UCD] in limited circumstances and cytokine release syndrome [CRS] associated with CAR‑T therapy). Scope: clinical coverage policy for siltuximab (Sylvant) detailing initial and continued therapy criteria, dosing limits, required documentation, and coding implications for Health Net / Centene lines of business. Effective date: 03.01.17. Last review / P&T approval: 02.25.

Key thresholds

Policy numberCP PHAR.329

Effective date03.01.17

Maximum dose11 mg/kg every 3 weeks

CRS total doses limit (continued therapy)Up to 4 doses total

Minimum treatment duration prior to continued review>= 30 days

Initial Therapy Criteria - Castleman's Disease (CD)

Initial Therapy Criteria - Cytokine Release Syndrome (CRS, off-label)

Continued Therapy - General

Continued Therapy - Castleman's Disease

Continued Therapy - Cytokine Release Syndrome (CRS)

Other Diagnoses / Off‑Label Referrals

Provider Actions & Prior Authorization Requirements

Prior Authorization

Documentation submission required

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Prior Authorization

Prescriber specialty requirement

Sylvant must be prescribed by or in consultation with an oncologist for Castleman's disease indications.

Applicable Codes

HCPCS referencedHCPCS

J2860

Injection, siltuximab, 10 mg

Clinical Evidence & Guidelines

Key evidence sources include the Sylvant Prescribing Information (Janssen Biotech, December 2019) and relevant NCCN guidance: Castleman Disease Version 1.2024 and Management of Immunotherapy-Related Toxicities Version 2.2024. These documents underpin the on-label MCD indication and the NCCN-supported off-label uses (UCD, CRS).

Background

Background: Siltuximab (Sylvant) is an interleukin-6 (IL-6) antagonist approved for treatment of multicentric Castleman's disease (MCD) in patients who are HIV negative and HHV-8 negative. The agent was not studied in MCD patients who are HIV positive or HHV-8 positive. The policy includes coverage criteria for on‑label MCD and for NCCN‑supported off‑label uses, including CRS associated with CAR‑T therapy and limited off‑label UCD.

Definitions

MCD (term)Multicentric Castleman's disease

UCD (term)Unicentric Castleman's disease

CRS (term)Cytokine release syndrome

CAR (term)Chimeric antigen receptor

HHV-8 (term)Human herpesvirus-8

HIV (term)

Revision History

1Q2021 (P&T Approval 02.21)revised

Annual review: lab parameters removed from criteria sets; references updated and HIM.PA.21 revised to HIM.PA.154.

1Q2022 (P&T Approval 02.22)revised

Annual review: added criteria set for NCCN compendium–supported use for CRS associated with CAR or autologous T cell therapy; references reviewed and updated.

1Q2023 (P&T Approval 02.23)revised

Annual review: minor template and reference updates with no significant clinical policy changes.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Siltuximab (Sylvant)

Policy CodePolicy CP PHAR.329

Change TypeAdded/Updated criteria (material and non-material)

Effective DateMar 1, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria.

SourceLink

On This Page

Prior Authorization

Off-label use supporting evidence

For off-label uses (for example UCD or CRS replacement), the prescriber must submit supporting evidence that the dose and regimen are supported by practice guidelines or peer‑reviewed literature.

Billing Rule

Dose limitation

HCPCS J2860. Dose must not exceed 11 mg/kg every 3 weeks unless supported by practice guidelines or peer‑reviewed literature; document and justify any dose increase.

Affected code: J2860
Maximum dose: 11 mg/kg every 3 weeks (unless supported and documented)

Documentation Required

HIV and HHV-8 testing required for MCD

Documented negative tests for HIV and HHV-8 are required for the MCD indication.

Prior Authorization

Approval durations

Initial approval durations: Castleman's disease — 6 months. For cytokine release syndrome (CRS) — approval up to a total of 4 doses.

Human immunodeficiency virus

1Q2024 (P&T Approval 02.24)added

In CRS initial criteria, added that Sylvant may be used to replace the second dose of Actemra (tocilizumab) or Tofidence per NCCN; references reviewed and updated.

1Q2025 (P&T Approval 02.25)addedLatest

In CRS initial criteria, added replacement for the second dose of Tyenne per NCCN and added Carvykti as an additional example of a CAR‑T therapy; later wording captured adding Tyenne and Carvykti as additional CAR‑T example.