CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization recommendation, covered indications, clinical criteria, dosing options and durations, prescribing specialist requirements, and nonrecommended uses for rituximab IV products (Rituxan and biosimilars) across FDA-approved and other supported indications.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision with multiple clinical updates

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for medical benefit coverage of rituximab IV products; requests for doses outside documented dosing are reviewed case-by-case by a clinician and specialist prescribing/consultation must be documented.

SourceLink

POLICY UPDATE CHANGES

ANCA-associated vasculitis dosing updated to specify a total of four doses for initial therapy and total of six doses for follow-up in patients ≥18 years and two doses for patients <18 years.

Immunotherapy-Related Toxicities Associated with Checkpoint Inhibitors condition of approval was added.

Multiple Sclerosis initial therapy requirement changed from trial of at least one to at least two other disease-modifying agents.

Neuromyelitis Optica Spectrum Disorder dosing specified as total of four weekly doses for 375 mg/m2 regimen.

Review date updated to 08/14/2024 (annual revision).

16+Indications listed (FDA-approved and supported evidence)

1New condition added

2024-08-14Last review date

Coverage Summary

Scope: This policy defines prior authorization recommendations, covered indications, dosing options and approval durations, specialist prescribing/consultation requirements, and nonrecommended uses for rituximab intravenous products (Rituxan and biosimilars). Coverage stance: covered_with_criteria — use is supported when the listed clinical criteria, dosing, and specialist requirements are met. Status/subject: Policy is CURRENT for Rituximab intravenous products utilization management (last reviewed 2024-08-14). Key stats: 16+ indications listed (FDA-approved and supported evidence), 1 new condition added (Immunotherapy-related toxicities), and last review date 2024-08-14.

Policy dates, counts, and top-level thresholds

Last review date2024-08-14

Has material changeYes (annual revision with multiple substantive updates)

Indications listed (FDA-approved and supported evidence)16+

Threshold - Minimum interval between coursesTypically ≥16 weeks for some indications (e.g., ANCA vasculitis, pemphigus); ≥6 months where specified (e.g., ITP, MS, SLE)

Threshold - Common dosing examples375 mg/m2 IV weekly x4; two 1,000 mg IV doses ≥2 weeks apart; up to 2,000 mg total over 1 month for MS; up to 500 mg per dose for some maintenance uses

Medical-Necessity Criteria and Dosing

General Prior Authorization and Prescriber Requirements

Prior Authorization is recommended. Initial approval requires specialist prescribing or consultation and approvals are for specified durations.

Prior Authorization is recommended for medical benefit coverage of rituximab IV products.

Initial approval requires rituximab to be prescribed by or in consultation with a physician who specializes in the condition treated.

Requests for doses outside established dosing documented in this policy will be considered case-by-case by a clinician (Medical Director or Pharmacist).

FDA-Approved Indications and Specific Criteria / Dosing

Coverage recommended when the specific indication criteria and dosing are met (each indication follows its own branch).

Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Conditions Not Recommended for Approval

Nonrecommended coverage

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Denial Risk

Not recommended for non-specified uses

Requests for uses not listed in the Recommended Authorization Criteria are not recommended for approval and may be denied.

Requests for uses not listed in the Recommended Authorization Criteria may be denied.

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of rituximab IV products; requests for doses outside the established dosing documented in this policy will be considered case-by-case by a clinician.

Prior authorization is recommended for medical benefit coverage.
Requests for doses outside established dosing are reviewed case-by-case by a clinician.

Documentation Required

Specialist prescribing/consultation requirement

Initial approval requires rituximab to be prescribed by or in consultation with a physician who specializes in the condition treated and this must be documented.

Example specialties: oncologist, rheumatologist, neurologist, dermatologist, immunologist, hematologist, transplant physician

Coding and Prior Authorization Routing

Clinical management / prior authorization routingmixed

No codes listed

Background, Evidence, and Definitions

Rituximab IV products (Rituxan and biosimilars such as Riabni, Ruxience, Truxima and others) are CD20-directed cytolytic antibodies indicated across multiple hematologic malignancies and immune-mediated diseases. Biosimilars have demonstrated biosimilarity to Rituxan — meaning no clinically meaningful differences in safety or effectiveness — but have only demonstrated biosimilarity and not interchangeability. Clinical guideline support for rituximab use exists across multiple specialty society guidelines and the policy includes detailed dosing, specialist-prescriber requirements, and indication-specific prior authorization criteria.

Evidence summary: guideline support is cited from major specialty sources including the American College of Rheumatology (ACR 2021) for ANCA-associated vasculitis, the American Society of Hematology (ASH 2019) for ITP, the National Comprehensive Cancer Network (NCCN 2023–2024) for multiple oncology indications and for management of immunotherapy-related toxicities, the Neuromyelitis Optica Study Group/NEMOS (2023) for NMOSD, and the European League Against Rheumatism (EULAR 2023) for SLE.

Definitions

Course of therapyOne course typically refers to the induction dosing schedule for the indication (e.g., two 1,000 mg doses separated by 2 weeks or 4 weekly doses of 375 mg/m2 depending on indication).

Revision History

2024-08-14material_revisionLatest

Annual revision updated ANCA-associated vasculitis dosing: induction therapy specified as a total of four doses (375 mg/m2 IV x4) and follow-up maintenance dosing specified as a total of six doses for patients ≥18 years and two doses for patients <18 years.

2024-08-14material_additionLatest

Added new condition: Immunotherapy-Related Toxicities Associated with Checkpoint Inhibitors as an approval condition with initial and prior-course criteria and dosing options (e.g., up to 500 mg IV x2 separated by 14 days or 375 mg/m2 IV x4 separated by ≥7 days).

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision with multiple clinical updates

Effective Date

Next Review Date

SourceLink

On This Page

A) Induction Treatment
- Approve for 1 month if patient has an ANCA-associated vasculitis (examples: granulomatosis with polyangiitis or microscopic polyangiitis).
- Medication is prescribed by or in consultation with an immunologist.
- Dosing: ONE of the following: 375 mg/m2 per dose IV for 4 doses separated by at least 7 days; OR up to two 1,000 mg IV doses separated by at least 2 weeks.
B) Follow-Up (Maintenance) Treatment
- Approve for 1 year if patient achieved disease control with induction treatment.
- Medication administered in combination with glucocorticoids (for follow-up when applicable).
- If patient previously received a course of therapy, at least 16 weeks will elapse between courses.
- Dosing (maintenance): examples include up to 500 mg per dose or schedules consistent with maintenance guidance.

B-Cell Lymphoma (multiple listed oncology indications): [EviCore] Approve for 1 year if prescribed by or in consultation with an oncologist. Dosing options include: up to 375 mg/m2 per dose IV with doses separated by at least 7 days; OR 375 mg/kg on two days of each cycle.

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma: [EviCore] Approve for 1 year if prescribed by or in consultation with an oncologist. Dosing: Approve up to 500 mg/m2 administered as an IV infusion on 1 day of each cycle.

Pemphigus Vulgaris

A) Initial Treatment: Approve for 1 month if therapy is initiated in combination with a corticosteroid unless contraindicated. Medication is prescribed by or in consultation with a dermatologist. Dosing: up to two 1,000 mg IV doses separated by at least 2 weeks; OR alternative dosing noted (maintenance of 500 mg per dose for maintenance).
B) Maintenance / Subsequent Therapy: Approve for 1 year if subsequent infusions administered no sooner than 16 weeks following the previous infusion. Medication is prescribed by or in consultation with a dermatologist.

Rheumatoid Arthritis

A) Initial Therapy: Approve for 1 month if patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Medication will not be used concurrently with another biologic or targeted synthetic DMARD. Medication prescribed by or in consultation with a rheumatologist. Dosing: one course consists of up to two 1,000 mg IV doses separated by at least 2 weeks.
B) Patient with prior rituximab courses for RA: Approve for 1 month if patient previously received one or more courses and meets criteria (16 weeks or greater between courses; medication not used concurrently with another biologic or targeted synthetic DMARD). If patient has already received two or more courses, additional requirement: patient experienced beneficial clinical response by at least one objective measure OR improvement in at least one symptom.

Acute Lymphoblastic Leukemia: [EviCore] Approve for 1 year if patient has CD20-positive disease and medication prescribed by or in consultation with an oncologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.

Graft-Versus-Host Disease (GVHD)

Initial Therapy: Approve for 1 month if patient has tried at least one conventional systemic treatment for GVHD (examples listed). Medication prescribed by or in consultation with an oncologist, hematologist, or transplant-affiliated physician. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.
B) Prior rituximab course for GVHD: Approve for 1 year if patient has received a prior course and meets at least one clinical improvement criterion (objective measure or symptom improvement).

Hairy Cell Leukemia: [EviCore] Approve for 1 year if prescribed by or in consultation with an oncologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.

Hodgkin Lymphoma (nodular lymphocyte-predominant): [EviCore] Approve for 1 year if patient has nodular lymphocyte-predominant disease and medication prescribed by or in consultation with an oncologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.

Immune Thrombocytopenia (ITP)

A) Initial Therapy: Approve for 1 month if patient has tried one other therapy (examples: IVIG, anti-D immunoglobulin, corticosteroids, splenectomy) and agent prescribed by or in consultation with a hematologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.
B) Prior rituximab course and relapse: Approve if patient responded to prior therapy per prescriber and relapsed; at least 6 months will elapse between treatment courses and prescriber has determined relapse.

Immunotherapy-Related Toxicities from Checkpoint Inhibitors

A) Initial Therapy: Approve for 1 month if patient symptomatic despite trial of at least ONE systemic corticosteroid. Dosing options: up to 500 mg/m2 IV for 2 doses separated by 14 days; OR up to 375 mg/m2 IV for 4 doses separated by at least 7 days. Examples of checkpoint inhibitors are listed in the policy.
B) Prior rituximab course: Approve for 1 month if prescribed by or in consultation with an oncologist, neurologist, rheumatologist, or dermatologist.

Multiple Sclerosis (MS)

A) Initial Therapy: Approve for 1 year if prescriber reports patient had inadequate efficacy or significant intolerance to at least TWO other disease-modifying agents for MS. Medication will not be used concurrently with another disease-modifying agent for MS. Medication prescribed by or in consultation with a neurologist or physician specializing in MS. Dosing: Approve up to 2,000 mg (total) administered as one or two IV infusions over 1 month.
B) Patient currently receiving rituximab: If patient has been receiving rituximab for <1 year: approve if medication not used concurrently with another disease-modifying agent; at least 6 months elapse between courses; prescribed by an MS specialist and patient has experienced stabilization, slow progression, or improvement by at least one objective measure or symptom. If patient has been receiving rituximab for >=1 year: approve for 1 year if medication not used concurrently with another disease-modifying agent; at least 6 months between courses; medication prescribed by MS specialist; and patient shows beneficial clinical response by objective measure or symptom improvement.

Neuromyelitis Optica Spectrum Disorder (NMOSD): Approve for 1 month if prescribed by or in consultation with a neurologist. Dosing: ONE of the following: up to two 1,000 mg IV doses separated by at least 2 weeks; OR 375 mg/m2 IV for 4 doses separated by at least 7 days.

Primary Central Nervous System Lymphoma: [EviCore] Approve for 1 year if prescribed by or in consultation with an oncologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.

Systemic Lupus Erythematosus (SLE)

A) Initial Therapy: Approve for 1 month if patient has tried at least ONE standard immunomodulating or immunosuppressant agent (examples: hydroxychloroquine, methotrexate, azathioprine, mycophenolate, cyclophosphamide). Medication prescribed by or in consultation with a rheumatologist, nephrologist, or neurologist.
B) Subsequent Therapy: Approve for 1 month if 6 months or greater will elapse between treatment courses. Dosing: Approve the requested dose.

Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma: [EviCore] Approve for 1 year if prescribed by or in consultation with an oncologist. Dosing: Approve up to 375 mg/m2 IV with doses separated by at least 7 days.

Billing Rule

Approval durations tied to indication

Approvals are provided for the duration noted per indication (examples include 1 month for an induction course and 1 year for many oncology and chronic-use indications); when approval is authorized in months, 1 month = 30 days.

1 month = 30 days (policy defines month equivalence).
Examples: 1 month induction courses (e.g., ANCA-associated vasculitis, pemphigus vulgaris, ITP initial therapy); 1 year approvals for many oncology and chronic-use indications.

Documentation Required

Prior therapy and trial requirements

For some indications providers must document prior therapies or trials before approval (requirements vary by indication).

Rheumatoid arthritis (RA): trial of ≥1 conventional synthetic DMARD for ≥3 months.
Multiple sclerosis (MS): trial of ≥2 other disease-modifying therapies (DMTs).
Immune thrombocytopenia (ITP): trial of ≥1 other therapy (examples: IVIG, anti-D immunoglobulin, corticosteroids, splenectomy).

Denial Risk

Not recommended for non-specified uses

Requests for uses not listed in the Recommended Authorization Criteria are not recommended for approval and may be denied.

Requests outside the criteria may be denied.

2024-08-14material_revisionLatest

Multiple Sclerosis initial therapy prior-treatment requirement tightened: now requires inadequate efficacy or intolerance to at least two other disease-modifying agents (changed from at least one).

2024-08-14material_revisionLatest

Neuromyelitis Optica Spectrum Disorder dosing clarified: the 375 mg/m2 IV regimen specified as a total of four weekly doses.

2024-08-14administrative_updateLatest

Administrative update: review date updated to 08/14/2024 (annual revision); prior 08/16/2023 review noted with no criteria changes.