CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sylvant (siltuximab) — Coverage Criteria for Idiopathic Multicentric Castleman's Disease (iMCD)

Defines accepted indications, continuation and exclusion criteria, and utilization management requirements for Sylvant (siltuximab) for network providers requesting medication authorization. Affects providers submitting prior authorizations for this drug.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySylvant (siltuximab) — Coverage Criteria for iMCD

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 26, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent Utilization Management with supporting FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11 mg/kgsingle dose maximum listed

HIV-1 negative; HHV-8 negativerequired virology status for iMCD coverage

3 conditionscontinuation exemption conditions

7reference sources listed

Coverage Criteria for Sylvant (siltuximab)

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inv-01: Indication: Idiopathic Multicentric Castleman's Disease (iMCD)

Covered when ALL of the following are met

iMCD coverage criteria: Member has active multicentric Castleman's disease as defined in Attachment A; member is HIV-1 negative AND HHV-8 negative; Sylvant (siltuximab) is being prescribed as monotherapy as first- or second-line therapy for iMCD.

Request must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per policy.

inv-02: Continuation therapy exemption

Continuation exemption (for otherwise not-approvable medication)

Continuation exemption: Requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance to the requested medication AND additional medication(s) are not being added to the continuation request.

Continuation requests meeting all three conditions are exempt from the Evolent policy limitations.

Coverage does not apply when Sylvant (siltuximab) is being used after disease progression with the same regimen or after progression on another interleukin‑6 receptor targeted therapy (for example, tocilizumab). Requests for therapy in members who are HIV‑1 positive or HHV‑8 positive are excluded. Concurrent administration with live vaccines or other anticancer therapies is not permitted under this policy. Additionally, dosing that exceeds the single‑dose limit of 11 mg/kg is an exclusion trigger. These criteria are used to identify situations where the medication is not medically appropriate under the plan.

Requests for Sylvant for investigational or off‑label indications will be denied when the supporting evidence is insufficient or not generally accepted by the medical community. Documentation must include citations from CMS‑recognized compendia or acceptable peer‑reviewed literature. Abstracts or meeting summaries without the full published article are inadequate supporting evidence. The policy considers whether the published evidence adequately represents the patient and disease characteristics, the specific regimen used, and whether outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as a hazard ratio < 0.80 or survival benefit of at least 3 months for OS/PFS). Case reports alone are generally insufficient; nonrandomized trials with substantial subject numbers may be supportive, whereas uncontrolled anecdotal reports are not.

Regimen	Indication	Coverage status
Sylvant (siltuximab) monotherapy
Monotherapy for idiopathic multicentric Castleman's disease (iMCD) in patients who are HIV-1 negative and HHV-8 negative; may be used as first- or second-line therapy.
Covered with criteria

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Medication requests for Sylvant (siltuximab) must be submitted to and processed by Evolent Utilization Management. Final approval authority rests with the Utilization Management Committee.

All medication requests processed by Evolent Utilization Management
Final approval by the Utilization Management Committee

Documentation Required

Required Supporting Evidence and Attachments

Requests must be supported by one or more of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards (see Medicare Benefit Policy Manual Chapter 15). Attachments must include relevant documentation such as FDA labeling, guideline citations, compendia references, and any peer-reviewed articles used to justify the request. See Attachment A for criteria for active disease when applicable.

Support with FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature
Include Attachment A: Criteria for Active Disease when applicable
Documentation should demonstrate that the evidence adequately represents the patient population, regimen, and clinically meaningful outcomes per CMS/ASCO standards

Denial Risk

Exclusion Triggers for Denial

Use of Sylvant (siltuximab) in the following situations will trigger denial:

Use after disease progression on the same regimen or after another IL-6 receptor–targeted therapy (e.g., tocilizumab/Actemra).
Use in members who are HIV-1 positive or HHV-8 positive.
Concurrent use with live vaccines or concurrent anticancer therapies when not permitted.
Dosing that exceeds the single-dose limit of 11 mg/kg.
Investigational or off-label use lacking sufficient evidence (not supported by CMS compendia or acceptable peer-reviewed literature).

Required Biomarker/Virology Status

inv-13: HIV-1, HHV-8 — must be negative

Required virology statusMember must be HIV-1 negative AND HHV-8 (human herpesvirus-8) negative

Coverage implicationUse in HIV-1 positive or HHV-8 positive members is an exclusion for coverage

Location in policyStated under iMCD coverage criteria and reinforced in exclusion criteria

inv-11: Active multicentric Castleman's disease (iMCD) — Definition referenced in Attachment A (Criteria for Active Disease)

Definition referenceActive multicentric Castleman's disease (iMCD) is defined in Attachment A: Criteria for Active Disease

Use for eligibilityAttachment A is used to determine eligibility for Sylvant therapy for iMCD

Policy locationReferenced in the iMCD coverage criteria section (see Attachment A)

Background

Sylvant (siltuximab) is a monoclonal antibody that targets interleukin‑6 and is indicated for treatment of idiopathic multicentric Castleman disease (iMCD) in patients who meet the policy criteria. Use must align with FDA labeling and acceptable compendia or peer‑reviewed literature; eligibility requires documentation of active iMCD per the Attachment A criteria and demonstration that the member is HIV‑1 negative and HHV‑8 negative. Per the policy, Sylvant may be used as monotherapy in the first‑ or second‑line setting for appropriately selected iMCD patients.

Policy Revision History

2024-07-26policy_effectiveLatest

Policy effective date established for Sylvant (siltuximab).

2024-07-10committee_approval

Committee approved the Sylvant (siltuximab) policy.

2023-07-12committee_review