ModifiedMass General Brigham Health PlanPolicy N/A

Riabni (rituximab-arrx)

Medical-benefit prior authorization policy governing use of rituximab products (including Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima) for FDA-approved and selected off-label indications for MassHealth members; defines diagnostic/therapeutic criteria, dosing appropriateness, approval durations, continuation and reauthorization rules, and prior therapy requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRiabni (rituximab-arrx)

Policy CodePolicy N/A

Change TypeModified — criteria and product roster updates

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization required for rituximab products under the MassHealth medical benefit; contact medical benefit PA phone 833-895-2611 (fax 888-656-6671).

SourceLink

POLICY UPDATE CHANGES

Effective 10/01/2025 roster lists Rituxan Hycela, Rituxan, Riabni, Ruxience, Truxima for MassHealth medical PA.

09/10/25 review: mycophenolate was added to required trials for polymyositis and dermatomyositis.

09/11/24 review: diagnosis criteria updated to include NHL subtypes in criteria; removal of LMB chemotherapy requirement for pediatric oncology.

05/10/23 review: added Riabni and Rituxan Hycela to criteria; updated PV criteria to prefer steroid + rituximab without prior immunosuppressive trial; updated GVHD and ITP criteria and added off-label indications.

02/08/2023 review: matched MassHealth UPPL criteria and added off-label indications; clarified approval durations. Effective 4/1/23.

5FDA-approved/primary indications listed

Off-label indications enumerated

6 monthsInitial approval (oncology)

12 monthsCommon reauthorization period

Coverage Summary

Scope: Medical-benefit prior authorization policy governing use of rituximab products (including Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima) for FDA-approved and selected off-label indications for MassHealth members; defines diagnostic and prior-therapy criteria, dosing appropriateness, approval durations, continuation/reauthorization rules, and prior therapy requirements.

Background: Rituximab is an anti-CD20 monoclonal antibody causing B-cell depletion used in multiple hematologic malignancies and autoimmune conditions.

Coverage stance and status: covered_with_criteria. Policy MODIFIED with material changes (product roster and criteria updates effective 10/01/2025 and other substantive revisions noted).

Key facts from brief

Effective date10/01/2025

Last review2025-09-10

Typical initial approval durations6 months (oncology pediatric and NHL/CLL); other indications vary (e.g., RA 4 months, PV 6 months, GPA/MPA induction 4 months)

Off-label indications count20+

Products included (medical benefit)Rituxan Hycela; Rituxan; Riabni; Ruxience; Truxima

Medical‑Necessity Criteria

General Authorization Exceptions

Authorization may be granted for members new to the plan who are currently receiving treatment with rituximab (excluding samples or manufacturer assistance) OR when criteria below are met and documentation provided:

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Coding

Products covered (medical benefit)mixedCovered

Riabni	rituximab-arrx (Amgen) - listed product name
Rituxan	rituximab (Genentech) - listed product name
Rituxan Hycela	rituximab/hyaluronidase human - listed product name
Ruxience	rituximab-pvvr - listed product name
Truxima	rituximab-abbs - listed product name

Provider Actions & Payment Rules

Prior Authorization

Prior authorization required (MassHealth medical benefit)

Prior authorization required for rituximab products under the MassHealth medical benefit; contact medical benefit PA phone 833-895-2611 (fax 888-656-6671).

Medical benefit PA phone: 833-895-2611
Medical benefit PA fax: 888-656-6671

Documentation Required

Document diagnosis and prior therapy trials

Prescriber must provide documentation of diagnosis, prior conventional therapy trials or contraindications/adverse reactions as specified for each indication (including off-label uses).

Include documentation of inadequate response, adverse reaction to, or contraindication to required conventional therapies per indication (examples listed in off-label sections; e.g., glucocorticoids, IVIG, plasma exchange for autoimmune encephalitis; azathioprine/cyclophosphamide/mycophenolate where specified)

Background & Evidence

Rituximab mechanism: Rituximab binds the CD20 antigen on B-lymphocytes, activating complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity, producing B-cell depletion and modulating diseases in which B-cells contribute to pathogenesis.

Product substitutions and dosing note: MassHealth medical-benefit coverage includes listed rituximab products; the subcutaneous hyaluronidase formulation (Rituxan Hycela) may be substituted after a member has received the first full IV dose of Rituxan per criteria.

MassHealth focus and PA: These rituximab products are processed under the MassHealth medical benefit prior authorization program (contact medical benefit PA phone 833-895-2611; fax 888-656-6671).

Off-label uses: Off-label approvals may be granted when conventional therapies have failed (documentation of prior conventional therapy trials, inadequate response, adverse reaction, or contraindication required).

Primary evidence sources include the Rituxan and Riabni prescribing information and published clinical guidelines and compendia.

Guideline and reference support cited: National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium, American College of Rheumatology (ACR) guidance, DRUGDEX/Micromedex resources, and peer-reviewed literature are listed as supporting references.

The policy references package inserts and formulary/compendium sources as the basis for indication-specific dosing, substitutions, and prior-therapy requirements.

Definitions

Appropriate dosingDosing consistent with FDA labeling or clinically accepted regimens for the specified indication (prescriber must document requested dosing).

Revision History

2019-12-16review

Added Truxima to criteria.

2021-05-19review

Updated and reviewed for May P&T; added Riabni and Rituxan Hycela to criteria.

2023-02-08formulary alignment

Matched MassHealth UPPL criteria to be in compliance with MassHealth unified formulary requirements; added off-label indications to appendix and clarified approval durations (effective 4/1/23).

Policy Summary

PayerMass General Brigham Health Plan

PolicyRiabni (rituximab-arrx)

Policy CodePolicy N/A

Change TypeModified — criteria and product roster updates

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization required for rituximab products under the MassHealth medical benefit; contact medical benefit PA phone 833-895-2611 (fax 888-656-6671).

SourceLink

On This Page

Billing Rule

Medical benefit reporting

Rituximab products are processed as medical benefit; contact medical benefit PA for coverage and billing questions; pharmacy benefit contact provided separately.

Medical benefit contact: Phone 833-895-2611, Fax 888-656-6671
Pharmacy benefit contact: Phone 800-711-4555, Fax 844-403-1029

Denial Risk

Denial risk for manufacturer sample/assistance program acquisitions

Authorization will not be granted for members new to the plan if the product was obtained as samples or via manufacturer's patient assistance programs.

Documentation Required

Continuation of therapy submissions infer response

Resubmission by prescriber for continuation/reauthorization will infer a positive response to therapy; include supporting documentation as required.

For reauthorization, include documentation of clinical response (progress notes, labs, imaging, or other objective measures) to support continued benefit

2023-05-10policy update

Multiple updates effective 6/5/23: added Riabni and Rituxan Hycela to criteria (noting FDA‑approved NHL subtypes), updated pemphigus vulgaris criteria to prefer steroid + rituximab without prior immunosuppressive trial, updated GVHD and ITP criteria, removed splenectomy requirement for ITP, and added several off-label indications.

2024-09-11criteria clarification

Clarified NHL subtypes placement within the criteria (moved from footnote into criteria) and removed requirement that rituximab be used with LMB chemotherapy for pediatric oncology per NCCN guidance (effective 10/1/24).

2025-09-10criteria revisionLatest

Added mycophenolate to required prior therapy trials for polymyositis and dermatomyositis (effective 10/1/25).

2025-10-01effective date / product rosterLatest

Effective 10/01/2025 roster lists Rituxan Hycela, Rituxan, Riabni, Ruxience, and Truxima for MassHealth medical prior authorization.