CurrentIndependent HealthPolicy M20200508037

Zevalin (ibritumomab tiuxetan) Policy

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

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

1Required prior authorization

>=18Minimum age (years)

Coverage Summary & Medical Necessity

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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) intravenously0.3 mCi/kg (11.1 MBq/kg); platelet 100,000-149,000 cells/mm3
Do not exceed the maximum dose of 32.0 mCi (1184 MBq)max 32.0 mCi (1184 MBq)

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

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.