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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:119
Effective Date: 01/17/2020
Original Policy Date:04/08/2016
Last Review Date:12/10/2019
Date Published to Web: 04/09/2016
Subject:
Siltuximab (Sylvant)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Siltuximab (Sylvant) is a human-mouse chimeric monoclonal antibody that binds human interleukin-6 (IL-6). It is produced by Chinese hamster ovary cells. Overproduction of IL-6 has been linked to systemic manifestations in patients with multicentric Castleman’s disease (MCD).

Castleman disease (CD) is a lymphoproliferative disorder, a disease of lymph nodes and related tissues. It was previously called Castleman’s disease. CD is also known as giant lymph node hyperplasia and angiofollicular lymph node hyperplasia. CD is not officially a cancer, but the multicentric form acts very much like lymphoma; many people with CD eventually develop lymphomas.

The two main forms of CD are localized and multicentric. MCD affects more than a single group of lymph nodes and can also affect other organs containing lymphoid tissue. Symptoms include serious infections, fevers, weight loss, fatigue, night sweats, and nerve damage that can cause weakness and numbness. There is no standard of therapy for MCD as no single treatment works for all patients. Corticosteroids, chemotherapy, and immunotherapy may produce long remissions for some patients. In other patients, the benefit does not last long and the symptoms worsen after the course of therapy is done. Some patients may not be helped by these drugs at all.

Siltuximab received FDA approval on April 22, 2014 for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab was not studied in patients with MCD who are HIV positive or HHV-8 positive because siltuximab did not bind to virally produced IL-6 in a nonclinical study.

The clinical efficacy and safety of SYLVANT for the treatment of patients with MCD was established in a phase 2, multinational, randomized (2:1) double blind, placebo controlled study. In this study 53 patients were randomized to Best Supportive Care (BSC) and SYLVANT at a dose of 11 mg/kg every 3 weeks and 26 patients were randomized to BSC and placebo. The major efficacy outcome of the study was durable tumor and symptomatic response, defined as tumor response (PR and CR based on modified International Working Group response criteria for malignant lymphoma) assessed by independent review and complete resolution or stabilization of MCD symptoms. Thirty-four MCD related symptoms were prospectively identified were collected and graded according to the NCI-CTCAE v 4 (National Cancer Institute-Common Terminology Criteria for Adverse Events), by investigator. A durable response was defined as tumor and symptomatic response that persisted for a minimum of 18 weeks without treatment failure. The durable tumor and symptomatic response in the SYLVANT arm 34% compared to 0% in the placebo arm (95% CI: 11.1, 54.8; p=0.0012). A consistent treatment effect was confirmed on subgroup analysis for all parameters evaluated with the exception of the hyaline vascular histological subtype. There were no patients with hyaline vascular histology who demonstrated a durable tumor and symptomatic response. However, activity was suggested in this subtype based on change in hemoglobin and median time to treatment failure. At the time of the analysis, overall survival data were not mature. One year survival rate was 100% in the SYLVANT arm and 92% in the placebo arm.

Policy:
[(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

The requirements of the Horizon BCBSNJ Siltuximab (Sylvant) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).]

I. Siltuximab (Sylvant) is medically necessary for the following FDA-approved indications:
    • Multicentric Castleman’s disease (MCD) who also meet the following criteria:
        • human immunodeficiency virus (HIV) negative; and
        • human herpesvirus-8 (HHV-8) negative
    • Patient is currently free of all clinically significant infections; AND
    • Patient will NOT receive any live vaccines while being treated with Sylvant AND
    • Patient has an absolute neutrophil count >1.0 x 109/L, a platelet count >75 x 109/L, and a hemoglobin level <17 g/dL
II. Siltuximab (Sylvant) is medically necessary for the following off-label indications:
    A. Second-line therapy as a single agent for relapsed or refractory unicentric Castleman’s disease (UCD) who also meet the following criteria:
      • Patient is:
          • human immunodeficiency virus (HIV) negative; and
          • human herpesvirus-8 (HHV-8) negative
      • Patient is currently free of all clinically significant infections; AND
      • Patient will NOT receive any live vaccines while being treated with Sylvant; AND
      • Patient has an absolute neutrophil count >1.0 x 109/L, a platelet count >75 x 109/L, and a hemoglobin level <17 g/dL
      B. Single-agent therapy for active multicentric Castleman's disease with no organ failure for patients who are human immunodeficiency virus-negative and human herpesvirus-8-negative
        • as primary treatment
        • for relapsed disease
        • if no response to primary treatment

III. When medically necessary, siltuximab (Sylvant) will be approved at the following FDA-recommended dose for 6 months:
    · 11 mg/kg dose given over 1 hour by intravenous infusion every 3 weeks

IV. Continued therapy will be authorized every 6 months when the following criteria are met:
    · Patient continues to meet criteria identified in section I; AND
    · Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND
    · Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: GI perforation, hyperuricemia, severe hypersensitivity and/or hematologic toxicity (neutropenia, thrombocytopenia) for which therapy should be interrupted; AND
    · Patient is currently free of all clinically significant infections; AND
    · Patient has an absolute neutrophil count >1.0 x 109/L, a platelet count >50 x 109/L, and a hemoglobin level <17 g/dL

V. Siltuximab (Sylvant) is considered investigational in conditions including, but not limited to, multiple myeloma, myelodysplastic syndrome, solid tumors, prostate cancer, and kidney cancer.

Medicare Coverage

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Siltuximab (Sylvant)
Sylvant (Siltuximab)

References:
1. Sylvant (siltuximab) [prescribing information]. Janssen Biotech, Inc. Horsham, PA. May 2018.

2. American Cancer Society. Castleman Disease. 11 June 2012. Available at: http://www.cancer.org/cancer/castlemandisease/detailedguide/index. Accessed May 2015.

3. National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Siltuximab. Available at: https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=417 [Accessed 11/25/2019]

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    HCPCS

        J2860

    * CPT only copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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