CurrentUnitedHealthcarePolicy CS2025D0003AR

Rituximab (non-oncology indications)

UnitedHealthcare Medical Benefit Drug Policy governing coverage and medical necessity criteria for rituximab injections for intravenous infusion for non-oncology conditions (specific products listed), including preferred product rules, general dosing/documentation requirements, diagnosis-specific indications, exclusions of certain uses, and applicable billing/diagnosis codes. Excludes certain states where state-specific policies apply.

Policy Summary

PayerUnitedHealthcare

PolicyRituximab (non-oncology indications)

Policy CodePolicy CS2025D0003AR

Change TypeAdded IgG4‑RD criteriaupdated drug listsadded ICD-10 code

Effective DateSep 1, 2025

Next Review Date

Key ActionFor IgG4-RD, confirm diagnosis using ACR/EULAR classification criteria and ensure prescription is by or in consultation with a specialist experienced in IgG4-RD.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate rituximab is proven for the treatment of IgG4-RD and established medical necessity criteria for IgG4-RD.

Updated lists of example drugs that the patient must have failed or must not be receiving in combination with rituximab.

Added ICD-10 diagnosis code D89.84 to applicable codes.

Updated Clinical Evidence and References sections and archived previous policy version CS2025D0003AQ.

1New proven indication added (IgG4-RD)

1New ICD-10 code added

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Coverage Summary

This policy governs coverage for intravenous rituximab injections for non-oncology autoimmune, inflammatory, and immunologic conditions (policy refers to Riabni, Rituxan, Ruxience, Truxima and other FDA‑approved rituximab biosimilars). Coverage is conditioned on diagnostic confirmation, specialist involvement, dosing attestation, and specified concurrent‑therapy exclusions as described in the Diagnosis‑Specific and General Requirements. Truxima and Ruxience are identified as the preferred rituximab products in applicable states, and coverage of Rituxan, Riabni or other non‑preferred rituximab products is provided only when the Preferred Product Criteria are met (e.g., prior trial, intolerance, or attestation of expected superior response). The policy overall stance is covered with criteria, with initial and reauthorization durations generally limited to no more than 12 months for listed indications.

Quick facts & thresholds

Platelet count threshold for ITP< 30 x 10^9 / L

Reauthorization duration (summary)Reauthorization will be for no more than 12 months

Initial authorization duration (summary)Initial authorization will be for no more than 12 months for listed indications

Effective dateSeptember 1, 2025

New proven indication addedImmunoglobulin G4-related disease (IgG4-RD) — rituximab added as proven/medically necessary with ACR/EULAR confirmation requirement

General and Preferred Product Requirements

Initial Therapy Criteria (Diagnosis-Specific)

Continuation Therapy Criteria

Not Medically Necessary / Unproven Indications

Applicable Codes

HCPCS/J-codes and Q-codes for rituximab productsHCPCS|mixed

J9311	Injection, rituximab 10 mg and hyaluronidase
J9312	Injection, rituximab, 10 mg
Q5115	Injection, rituximab-abbs, biosimilar, (Truxima), 10 mg
Q5119	Injection, rituximab-pvvr, biosimilar, (Ruxience), 10 mg
Q5123	Injection, rituximab-arrx, biosimilar, (Riabni), 10 mg

Applicable ICD-10 Diagnosis Codes (referenced)ICD-10

D47.Z1	Post-transplant lymphoproliferative disorder (PTLD)
D59.0	Drug-induced autoimmune hemolytic anemia
D59.10	Autoimmune hemolytic anemia, unspecified
D59.11	Warm autoimmune hemolytic anemia
D59.12	Cold autoimmune hemolytic anemia
D59.13	Mixed type autoimmune hemolytic anemia
D59.19	Other autoimmune hemolytic anemia
D69.3	Immune thrombocytopenic purpura
D89.84	IgG4-related disease
G04.81	Other encephalitis and encephalomyelitis

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Applicable ICD-10 diagnosis codes (listed in this part)ICD-10

M06.861	Other specified rheumatoid arthritis, right knee.
M06.862	Other specified rheumatoid arthritis, left knee.
M06.862	Other specified rheumatoid arthritis, unspecified knee.
M06.871	Other specified rheumatoid arthritis, right ankle and foot.
M06.872	Other specified rheumatoid arthritis, left ankle and foot.
M06.88	Other specified rheumatoid arthritis, vertebrae
M06.89	Other specified rheumatoid arthritis, multiple sites.
M06.9	Rheumatoid arthritis, unspecified.
M30.0	Polyarteritis nodosa.
M30.1	Polyarteritis with lung involvement (Churg-Strauss).

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Added ICD-10 diagnosis codesICD-10Covered

D89.84

Immunoglobulin G4-related disease (newly added as applicable diagnosis code)

Provider Actions and Prior Authorization

Documentation Required

Prescriber attestation of dosing for initial therapy

For initial therapy requests, prescriber must attest that dosing is consistent with the United States Food and Drug Administration (FDA) approved labeling OR, for indications without FDA-approved dosing, that there is published clinical evidence to support the dosing. This attestation must be included with the request.

Applies to all initial rituximab medical necessity requests

Documentation Required

Continuation therapy documentation

For continuation/reauthorization requests, clinical documentation must show a positive clinical response to prior rituximab therapy and include a prescriber attestation that current dosing is in accordance with FDA-approved labeling or, when no FDA dosing exists for the indication, supported by published clinical evidence. Include objective measures of response when available (e.g., labs, imaging, clinical scores).

Documented positive clinical response required for continuation requests
Prescriber dosing attestation required for continuation requests

Clinical Evidence

58%ITP sustained response at 6 months (rituximab + dexamethasone) vs 37% dexamethasone alone (p=0.02)

88%NMOSD relapse reduction (up to) and 70% relapse-free at 24 months in one study

88-97%IgG4‑RD high response rates in series (pooled/series: 88–97%) with longer relapse-free survival on maintenance

The evidence supporting use across indications includes randomized and controlled trials, prospective open‑label studies, retrospective series, and systematic reviews. Major high‑quality trials/series cited include a phase 3 randomized ITP trial showing improved sustained response with rituximab + dexamethasone versus dexamethasone alone; a phase 2 MS trial (Hauser) demonstrating reductions in gadolinium‑enhancing lesions and relapse rates through 48 weeks; multiple series and prospective studies in IgG4‑RD with high response rates and longer relapse‑free survival with maintenance; a Cochrane review and pooled data for rheumatoid arthritis showing benefit when combined with methotrexate; and open‑label/phase II TTP studies showing shorter time to durable remission and reduced relapse versus historical controls. Safety communications from the FDA regarding hepatitis B reactivation risk with rituximab are also referenced and included in provider monitoring requirements.

Background and Definitions

Rituximab is a chimeric anti‑CD20 monoclonal antibody used for multiple non‑oncology autoimmune, hematologic and neurologic disorders; the policy covers IV rituximab products for these non‑oncology indications but excludes Rituxan Hycela for non‑oncology uses. Key definitions include: Rituximab (policy usage) referring to listed IV rituximab products for non‑oncology conditions with explicit exclusion of Rituxan Hycela; CR and PR definitions vary by study (examples provided for chronic cold agglutinin disease); and IgG4‑RD defined with diagnosis confirmation by ACR/EULAR classification criteria. The policy requires specialist prescribing or consultation for certain diagnoses (for example, IgG4‑RD and NMOSD) and prohibits combining rituximab with specified disease‑modifying therapies for several conditions.

Definitions

Rituximab (policy usage)Refers to listed rituximab products for IV infusion for non-oncology conditions; excludes Rituxan Hycela for non-oncology (considered unproven).

CRComplete response (study-specific definitions vary; example in CAD: absence of anemia, no hemolysis, no clinical symptoms, no detectable monoclonal protein, no clonal lymphoproliferation).

PRPartial response (study-specific definitions vary; example in CAD: Hgb increase ≥2 g/dL or to normal range, IgM reduction ≥50% or to normal, clinical improvement, transfusion independence).

Revision History

09/01/2025policy_updateLatest

Added language that rituximab is proven for the treatment of Immunoglobulin G4-related disease (IgG4-RD); established medical necessity criteria for IgG4-RD including confirmation by ACR/EULAR classification criteria, specialist prescribing/consultation requirement, exclusion of concomitant disease-modifying therapy for IgG4-RD (example: Uplizna/inebilizumab-cdon), and initial/reauthorization duration limits (no more than 12 months). (type: added; is_material: true)

09/01/2025policy_updateLatest

Updated rheumatoid arthritis criteria: expanded examples of tumor necrosis factor (TNF) inhibitors to include Cimzia (certolizumab) and Simponi (golimumab); updated examples of targeted immunomodulators not to be combined with rituximab to add Olumiant (baricitinib), Orencia (abatacept), and Rinvoq (upadacitinib). (type: revised; is_material: true)