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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyIndependent Health Zevalin Coverage & Prior Auth |…
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    CurrentIndependent HealthPolicy M20200508037

    Zevalin (ibritumomab tiuxetan) Policy

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    Defines medical necessity criteria, dosing, and prior authorization requirement for Zevalin (ibritumomab tiuxetan) for treatment of non-Hodgkin's lymphoma across commercial, Medicare Advantage, MediSource, and Essential Plan lines of business.

    Policy Summary
    PayerIndependent Health
    PolicyZevalin (ibritumomab tiuxetan) Policy
    Policy CodePolicy M20200508037
    Change TypeFormatting / routine review
    Effective DateJul 1, 2020
    Last ReviewSep 1, 2025
    Next Review Date
    Key ActionObtain prior authorization before providing Zevalin and document age, platelet count, marrow cellularity, percent bone marrow involvement, prior therapies and prior response status to support medical necessity.
    SourceLink
    POLICY UPDATE CHANGES

    Notes indicate formatting revisions on 9/1/2025 and routine reviews on multiple prior dates; latest note 9/1/2025 states 'Revised Formatting only.'

    6Key clinical eligibility thresholds

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    1
    Required prior authorization
    >=18Minimum age (years)

    Coverage Summary & Medical Necessity

    Defines medical necessity criteria, dosing, and prior authorization requirements for Zevalin (ibritumomab tiuxetan) for treatment of non-Hodgkin's lymphoma across commercial, Medicare Advantage, MediSource, and Essential Plan lines of business; coverage status is covered with criteria when the policy's clinical eligibility requirements are met.

    Medical Necessity / Clinical Indications

    Zevalin is considered medically necessary when ALL of the following are met:

    ALL of the following

    • Patient is 18 years or older
    • Patient must not have a platelet count < 100,000 cells/mm3>= 100,000 cells/mm3
    • Must be used in combination with rituximab
    • Patient has adequate marrow cellularity of >15%>15%
    • Patient has <25% involvement of lymphoma in bone marrow<25%
    • Ibritumomab was not previously given

    • Indication types (one or more)

      • Relapsed, refractory or progressive, low-grade or follicular non-Hodgkin's lymphoma (NHL)
      • Previously Untreated Follicular NHL and patient achieved a partial or complete response to first-line chemotherapy
      • Treatment is used as second-line or subsequent therapy for relapsed or refractory primary cutaneous disease of the type leg
      • Diffuse Large B-cell Lymphoma (DLBCL) and 1 or more of the following:
      • Treatment is used as subsequent therapy in patients who have had histologic transformation from marginal zone lymphoma or follicular lymphoma and 1 or more of the following:
      • Histologic transformation from follicular lymphoma where patient experienced either a partial or no response or had progressive disease to treatment and received minimal or no treatment prior to histologic transformation (follicular lymphoma without translocations of MYC and BCL2 and/or BCL6)

    Dosage, Administration & Provider Requirements

    Dosage and Administration Constraints

    Dosing restrictions and maximums:

    ALL of the following

    • Administer rituximab 250 mg/m2 Day 1; repeat dose on Day 7, 8, or 9
    • Within 4 hours of the second dose of rituximab, administer ibritumomabwithin 4 hours
    • Normal platelet counts: 0.4 mCi/kg (14.8 MBq/kg) intravenously0.4 mCi/kg (14.8 MBq/kg)
    • Relapsed/refractory patients with platelet count of 100,000 to 149,000 cells/mm3: 0.3 mCi/kg (11.1 MBq/kg) intravenously

    Policy Identifiers & Codes

    Policy identifiermixed
    M20200508037Internal policy number listed in document header

    Clinical Evidence Summary

    60-80%Response rates in prospective trials (previously treated disease)
    Overall <1 yr; CR ~4 yrMedian progression-free survival: less than one year overall; patients with complete remission median approx. 4 years

    Zevalin is approved for patients with relapsed or refractory follicular non-Hodgkin lymphoma, including those with rituximab-refractory disease; prospective trials report overall response rates of approximately 60-80% in previously treated patients.

    Eligibility Thresholds

    Key eligibility thresholds and dosing
    Age>= 18 years
    Platelet count (eligibility)>= 100,000 cells/mm3 (policy states patient must not have platelet count < 100,000)
    Marrow cellularity> 15%
    Bone marrow involvement< 25% lymphoma involvement in bone marrow
    Dosage (normal platelet)0.4 mCi/kg (14.8 MBq/kg) IV
    Dosage (low platelet)0.3 mCi/kg (11.1 MBq/kg) IV for platelet 100,000-149,000 cells/mm3
    Maximum doseDo not exceed 32.0 mCi (1184 MBq)

    Background & Definitions

    Zevalin (ibritumomab tiuxetan) is a murine anti-CD20 monoclonal antibody conjugated to yttrium-90 used as a radiotherapeutic agent for recurring or refractory CD20+ non-Hodgkin's lymphoma. It is FDA-approved for relapsed or refractory follicular lymphoma, including rituximab-refractory disease.

    Definitions: - Non-Hodgkin's Lymphoma (NHL): a lymphoproliferative malignancy usually originating in lymphoid tissues and spreading to other organs. - Zevalin (ibritumomab tiuxetan): a radiotherapeutic murine anti-CD20 monoclonal antibody conjugated to yttrium-90 for treatment of recurring or refractory CD20+ NHL.

    Policy Revision History

    2025-09-01Formatting/ReviewLatest

    Revised Formatting only; formatting-only revision noted (non-material).

    2025-06-01Formatting/Review

    Routine review completed (non-material).

    2024-06-01Formatting/Review
    Policy Summary
    PayerIndependent Health
    PolicyZevalin (ibritumomab tiuxetan) Policy
    Policy CodePolicy M20200508037
    Change TypeFormatting / routine review
    Effective DateJul 1, 2020
    Last ReviewSep 1, 2025
    Next Review Date
    Key ActionObtain prior authorization before providing Zevalin and document age, platelet count, marrow cellularity, percent bone marrow involvement, prior therapies and prior response status to support medical necessity.
    SourceLink
    On This Page
    Coverage Summary & Medical NecessityDosage, Administration & Provider RequirementsPolicy Identifiers & CodesClinical Evidence SummaryEligibility ThresholdsBackground & DefinitionsPolicy Revision History
  1. Patient received multiple prior therapies including 22 lines of chemoimmunotherapy for indolent or transformed disease
    2. 0.3 mCi/kg (11.1 MBq/kg); platelet 100,000-149,000 cells/mm3
  2. Do not exceed the maximum dose of 32.0 mCi (1184 MBq)max 32.0 mCi (1184 MBq)
    3. Prior Authorization

    Pre-authorization required

    Pre-authorization is required for Zevalin; obtain prior authorization before service.

    Billing Rule

    Dosing and administration timing

    Report dosing consistent with protocol: rituximab 250 mg/m2 Day 1 and Day 7/8/9, ibritumomab administered within 4 hours of second rituximab dose; do not exceed max dose 32.0 mCi.

    • Rituximab 250 mg/m2 on Day 1 and repeat on Day 7, 8, or 9
    • Administer ibritumomab within 4 hours of the second rituximab dose
    • Normal platelet dosing: 0.4 mCi/kg (14.8 MBq/kg)
    • Platelet 100,000–149,000 cells/mm3 dosing: 0.3 mCi/kg (11.1 MBq/kg)
    • Do not exceed maximum dose of 32.0 mCi (1184 MBq)
    Documentation Required

    Clinical documentation to support medical necessity

    Document age, platelet count, marrow cellularity percentage, percent bone marrow involvement, prior therapies and prior response status to support criteria.

    • Patient age (>= 18 years)
    • Platelet count (must not be < 100,000 cells/mm3)
    • Marrow cellularity percentage (> 15%)
    • Percent bone marrow involvement (< 25%)
    • Prior therapies received and prior response status

    Routine review completed (non-material).

    2024-01-01Formatting/Review

    Revision recorded (non-material).

    2023-06-01Formatting/Review

    Routine review completed (non-material).

    2022-06-01Formatting/Review

    Routine review completed (non-material).

    2021-06-01Formatting/Review

    Routine review completed (non-material).

    2020-07-01Formatting/Review

    Policy effective date recorded.

    2025-09-01Formatting/ReviewLatest

    Last review date per policy header.