ModifiedPremera BluecrossPolicy MEDICAL POLICY -5.01.556

Rituximab: Non-oncologic and Miscellaneous Uses

Defines medical necessity, site-of-service review, and covered non-oncologic indications for rituximab products (Riabni, Ruxience, Truxima, and Rituxan) and related documentation and approval durations; applies to providers requesting coverage for these drugs.

Policy Summary

PayerPremera Bluecross

PolicyRituximab: Non-oncologic and Miscellaneous Uses

Policy CodePolicy MEDICAL POLICY -5.01.556

Change TypeModified (2026 criteria update)

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization for rituximab products and document indication, prior treatments, and rationale per policy; initial approvals up to 6 months with re-authorizations up to 12 months if responding.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for rheumatoid arthritis preferring adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm as alternatives and removed Humira (adalimumab) [NDCs starting with 00074] as a first-line step therapy option.

Changed product formulary statuses among rituximab products: Ruxience moved between preferred/non-preferred positions; Riabni, Ruxience, Truxima and others updated with trial/failure sequencing requirements.

Site-of-service medical necessity criteria exception for certain individuals receiving treatment for cytokine release syndrome (CRS).

Medications listed in the policy are subject to the FDA dosage and administration prescribing information.

6 monthsInitial authorization max

12 monthsRe-authorization max

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Coverage Criteria and Indications

Glucocorticoid‑Refractory Chronic Graft‑Versus‑Host Disease (GVHD)

Covered when ALL of the following are met:

ALL of the following

The individual has a documented diagnosis of chronic graft‑versus‑host disease (chronic GVHD) defined as disease occurring >100 days post‑allogeneic hematopoietic cell transplantation.
The chronic GVHD is glucocorticoid‑refractory, defined as lack of adequate clinical response to systemic corticosteroid therapy (with or without a calcineurin inhibitor) at standard doses and duration, or the individual is corticosteroid‑dependent with unacceptable corticosteroid‑related toxicity.
There is documentation of prior trials and therapeutic rationale in the medical record (e.g., chart notes documenting inadequate response, intolerance, or contraindication to first‑line agents such as mycophenolate mofetil, cyclophosphamide, or cyclosporine).
Rituximab (any rituximab product) is being used as treatment for chronic GVHD and the request specifies product and dosing consistent with the product’s FDA‑approved dosing or peer‑reviewed clinical practice standards.
For authorization of Rituxan or Rituxan Hycela (non‑preferred products), documentation demonstrates inadequate response to or intolerance of preferred rituximab products (e.g., Ruxience, Truxima, or Riabni) unless an exception applies (see policy sequencing rules).

Coverage context and policy‑wide constraints

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Coding and Billing Codes

HCPCS codes listedHCPCS

J3590	Unclassified biologics (use to report: Amjevita , Cyltezo, Hyrimoz HCF, Sandoz and Simlandi)
J9311	Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela)
J9312	Injection, rituximab (Rituxan), 10 mg
Q5115	Injection, rituximab-abbs, biosimilar, (Truxima), 10mg
Q5119	Injection, rituximab-pvvr, biosimilar, (Ruxience), 10 mg
Q5123	Injection, rituximab-arrx, biosimilar, (Riabni), 10 mg
Q5156	Injection, tocilizumab-anoh (Avtozma), biosimilar, 1 mg (new code effective 10/01/25)

Neutral / policy-level coding notesmixed

affected codes

Policy references site-of-service review and coverage criteria updates for rituximab products and biosimilars; specific CPT/HCPCS codes not listed in this document segment.

Formulary NDC prefixes and referenced productsNDC

NDCs starting with 00074	Humira (adalimumab) (AbbVie) — referenced preferred product status for RA previously
NDCs starting with 55513	Amjevita adalimumab biosimilar referenced in formulary changes
NDCs starting with 83457	Hyrimoz (Cordavis) adalimumab biosimilar referenced
NDCs starting with 61314	Hyrimoz (Sandoz) adalimumab-adaz referenced (preferred -> non-preferred change)
NDCs starting with 00597	adalimumab-adbm and related NDC prefix noted in 2026 update

Rituximab HCPCS / unlisted codes referenced in historyHCPCS

J9311	HCPCS code added (rituximab)
J9312	HCPCS code added (rituximab)
Q5115	HCPCS code supporting Truxima
Q5119	HCPCS code for Ruxience
J3590	Unlisted code added/removed in history
Q5123	HCPCS code added
Q5156	HCPCS code added (effective 10/01/25)

inv-37: Non-formulary exception approval duration (historical)

Non-formulary exception prior approval duration (historical)May be approved up to 12 months (policy language added in 2025; later removed/updated)

Initial prior authorization duration (current policy)Up to 6 months for initial approvals (see prior authorization section)

Re-authorization duration (current policy)Up to 12 months for re-authorizations when clinical response documented

Context for change2025 update clarified non-formulary exception authorizations may be approved up to 12 months; policy language was subsequently revised/removed in later updates.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required; Approval Lengths

Prior authorization is required for all rituximab products listed in this policy. Initial authorizations may be approved up to 6 months. Re-authorizations may be approved up to 12 months provided the drug-specific coverage criteria continue to be met and chart notes document a sustained clinical benefit.

Applies to all rituximab products in this policy (including Rituxan, Rituxan Hycela, Riabni, Ruxience, Truxima and biosimilars).
Providers must follow the product's FDA dosing and administration prescribing information when requesting authorization.

Prior Authorization

Prior Authorization for Transplant-related Uses

Requests for rituximab for transplant-related uses (including HLA desensitization and treatment of antibody-mediated rejection) require prior authorization. Documentation must specifically support the transplant-related indication (see Documentation Requirements block).

Pretransplant HLA desensitization in kidney transplant candidates is a covered indication when documentation supports HLA-sensitization and desensitization attempts; prior authorization required.

Background and Evidence Summary

Rituximab is a chimeric anti‑CD20 monoclonal antibody that depletes B cells and is used across multiple autoimmune and hematologic conditions. The agent’s mechanism—targeting CD20 on pre‑B and mature B lymphocytes—underpins its role in disorders where pathological B‑cell activity contributes to disease. Safety considerations include labeled boxed warnings and important infectious and hematologic adverse events; reviewers should reference product prescribing information when evaluating dosing and administration.

Bibliographic references supporting the policy’s clinical claims and coverage positions are listed in the reference section; these citations should be consulted for detailed evidence summaries and original trial data when preparing clinical justifications or appeals.

Reference‑only sections of the policy provide supporting literature but do not contain independent not‑medically‑necessary determinations; formal NMN positions are stated in the coverage and not‑medically‑necessary sections elsewhere in the policy.

Definitions and Product List

inv-72: Rituximab products covered

Branded productRituxan (rituximab)

Biosimilar — TruximaTruxima (rituximab-abbs)

Biosimilar — RuxienceRuxience (rituximab-pvvr)

Biosimilar — RiabniRiabni (rituximab-arrx)

Combination productRituxan Hycela (rituximab with hyaluronidase) — referenced separately for sequencing and formulary status

inv-73: Site of service (SOS) definition and SOS medical necessity criteria summary

Definition of SOS

Policy Revision History and Updates

2026-06-01effective_dateLatest

Policy effective date updated to 2026-06-01 with material changes to rheumatoid arthritis sequencing (preferred adalimumab alternatives) and removal of Humira as first-line, plus reclassification of rituximab biosimilars and a CRS site-of-service exception.

2025-10-01formulary_change

Interim updates effective 2026-01-02 revised preferred/non-preferred status of rituximab products and required trials, and removed Humira as a first-line option in RA criteria (provider notification periods noted).

2025-03-01policy_update

Policy Summary

PayerPremera Bluecross

PolicyRituximab: Non-oncologic and Miscellaneous Uses

Policy CodePolicy MEDICAL POLICY -5.01.556

Change TypeModified (2026 criteria update)

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Prior Authorization

Prior Authorization for Nephrology and ANCA-associated Vasculitis Indications

Prior authorization is required for nephrology indications (e.g., idiopathic membranous nephropathy, membranous nephropathy with risk factors) and ANCA-associated vasculitis (AAV). Approvals should reflect guideline-preferred indications and sequencing (see related guideline summaries).

Membranous nephropathy: rituximab may be covered for patients with moderate-to-high risk of progression or after failure of previous immunosuppressive regimens; authorization must document risk factors or prior therapy.
AAV: authorization should document why rituximab is indicated per guideline-preferred populations (e.g., cyclophosphamide contraindication, fertility concerns, relapsing disease, PR3-ANCA, frail older adults, or children/adolescents).

Note

Consult Product Prescribing Information

Consult the product prescribing information for the specific rituximab product requested when preparing an authorization. PI references for Truxima, Ruxience, and Riabni are included in the policy references and were updated June 2025.

Authorization requests must follow FDA dosing and administration in the PI.
Product-specific HCPCS/NDC and administration notes in the PI should be provided when applicable.

Prior Authorization

Prior Authorization for Rituximab Products and Product Sequencing

Prior authorization is required for requests for rituximab products. Note that product preference/step therapy sequencing may require trials of preferred biosimilars or alternatives before authorizing non-preferred rituximab products.

Policy lists preferred and non-preferred rituximab products; non-preferred products (e.g., Rituxan, Rituxan Hycela in recent updates) may require documented trial and failure of all preferred rituximab products.
HCPCS codes for rituximab products are maintained in the policy history and should be included on claims and authorization requests when applicable.

Denial Risk

Site-of-Service Denial Risk

Infusion site-of-service requirements apply. Infusion in a hospital outpatient setting may be considered not medically necessary when site-of-service criteria are not met; document why infusion cannot occur in office, home, or infusion center when requesting hospital outpatient administration.

Site-of-service medical necessity criteria do not apply to Alaska fully-insured members (Alaska HB 226); consult member's plan for applicability.
Exceptions exist for cytokine release syndrome (CRS) meeting severe criteria—document condition and rationale for hospital-based infusion.

Denial Risk

Investigational Uses and Documentation Deficiencies Trigger Denials

Requests for investigational uses or those lacking required documentation may be denied. Rituximab is considered investigational for many non-oncologic uses not specifically listed as covered in this policy.

Examples of investigational indications include induction immunosuppression for kidney or heart transplantation, treatment of minimal change disease, myasthenia gravis, multiple sclerosis, prophylaxis for graft-versus-host disease, and others listed in the policy.
Incomplete documentation of diagnosis, prior therapies, or infusion site justification is a common cause for denial.

Note

RCT Evidence for Rituximab in Transplant Induction

Randomized controlled trials did not show clear benefit for adding rituximab to induction immunosuppression in kidney transplant candidates; therefore routine use of rituximab for induction is not supported by high-quality RCT evidence.

RCTs found no signal of more benefit or less harm with rituximab versus placebo as an add-on to maintenance immunosuppression in kidney transplant induction.
Use of rituximab for heart transplant induction is based on case reports/expert opinion and is considered insufficient evidence for routine coverage.

Denial Risk

Use of Rituximab for Induction Immunosuppression

Use of rituximab as part of induction immunosuppression for kidney or heart transplantation is not routinely supported by RCT evidence and is generally considered investigational for induction; prior authorization requests should include trial evidence and strong clinical justification.

Authorization requests for induction regimens must include RCT evidence or compelling clinical rationale when deviating from standard induction therapies.
Routine add-on use for induction without supporting evidence may be denied.

Denial Risk

Use of Rituximab for Antibody-mediated Rejection (ABMR)

Evidence for rituximab in antibody-mediated rejection (ABMR) is limited to retrospective or small prospective studies; because larger RCTs are lacking, use for ABMR is considered of uncertain benefit and may be denied absent supportive data.

For ABMR, prior authorization should document prior trials of plasmapheresis, IVIG, and corticosteroids when applicable.
Small cohort or case series alone may be insufficient for approval; provide detailed clinical course and rationale.

Prior Authorization

ANCA-associated Vasculitis Eligibility Constraints

ANCA-associated vasculitis (AAV) eligibility for rituximab follows guideline-based constraints: rituximab plus glucocorticoids is an option for induction when cyclophosphamide is contraindicated, fertility preservation is a concern, cumulative cyclophosphamide dose would be exceeded, for relapsing disease, PR3-ANCA disease, children/adolescents, or frail older adults. Authorization must document why rituximab is preferred in the individual.

KDIGO and other guideline recommendations identify populations where rituximab is preferred over cyclophosphamide; include this context in the authorization.
Maintenance therapy recommendations (rituximab vs azathioprine) and reinduction for relapsing disease are noted in guideline summaries.

Step Therapy

Prior Trial Requirement for Non-preferred Rituximab Products

Non-preferred rituximab products may require documented trials and failures of all preferred rituximab products or preferred alternatives prior to coverage. Authorization requests for non-preferred agents should include prior step-therapy documentation.

Policy history documents changes in preferred/non-preferred status; verify current product status and required trials at time of request.
Examples: recent policy updates moved Ruxience or Riabni among preferred/non-preferred lists; check policy effective dates for applicability.

Note

No Explicit Authorization/Denial Criteria in This Callout

This section provides provider-impact guidance but does not replace explicit authorization/denial criteria elsewhere in the policy. For definitive medical necessity decisions, consult the policy's criteria and criteria_group sections.

Reference-only summaries here are not a substitute for reviewing the full coverage criteria and documentation checklists included elsewhere in the policy.

Denial Risk

Benefit Limitation Denials

Coverage is subject to member benefit plan limits. Providers must consult the member's benefit booklet or contact customer service to confirm applicable benefit limitations; denials may result from plan exclusions or limits regardless of medical necessity.

This medical policy does not apply to Medicare Advantage.
Benefit limitations (e.g., frequency, site-of-service exclusions) may affect coverage decisions.

Documentation Required

Required Documentation

Required documentation must be submitted with authorization requests. The medical record should document diagnosis/condition, history and physical exam with severity, prior treatments (including trials of preferred agents), and if requesting outpatient hospital-based infusion, explanation why alternative sites are not appropriate.

For HLA-sensitized kidney transplant candidates include panel reactive antibody (PRA) levels and prior desensitization attempts.
For TTP include disease severity, concomitant plasma exchange and corticosteroids, and ADAMTS13 activity levels when available.
For transplant desensitization or induction requests include the transplant center protocol and rationale.

Documentation Required

Required Clinical Documentation

Required clinical documentation specifics include a history and physical, severity measures, prior therapies and responses, and infusion setting details when applicable. Chart notes must substantiate the medical necessity criteria for the requested indication.

Document prior trial/failure of standard therapies (e.g., TNF inhibitors, methotrexate for RA; plasmapheresis/IVIG/corticosteroids for ABMR) when step therapy is part of criteria.
Include dosing, dates of therapy, and objective measures of response or intolerance.

Documentation Required

HLA-sensitized Kidney Transplant Documentation

For HLA-sensitized kidney transplant candidates seeking desensitization, prior authorization must include PRA levels, evidence of broad alloantibody reactivity, and documentation of prior desensitization attempts (e.g., IVIG, plasmapheresis).

Cohort studies support improved outcomes with rituximab-containing desensitization regimens; include center protocol and anticipated post-transplant monitoring plan.

Documentation Required

TTP Documentation Requirements

For thrombotic thrombocytopenic purpura (TTP), documentation should include disease severity, use of plasma exchange and corticosteroids, response to initial therapies, and ADAMTS13 activity levels when available. Guideline-recommended use of rituximab in acute, refractory, or relapsing TTP should be referenced.

Guidelines (BCSH, ISTH) recommend considering rituximab on admission for acute idiopathic TTP with neurological or cardiac pathology and in refractory/relapsing disease; document adherence to these recommendations.
If rituximab is requested for prophylaxis in remission, provide serial ADAMTS13 activity data and rationale.

Note

Bibliographic References and Prescribing Information

This section contains bibliographic references and prescribing information citations to support the clinical and coverage statements. Providers may consult the referenced guidelines and PIs when preparing authorization requests.

Key guideline references include KDIGO (2024), ISTH (2020), BCSH (2012), and ACR/VCF guidance for AAV.
Product PIs last revised June 2025 are cited in the references section.

Documentation Required

Documentation Requirement (Policy History Note)

A documentation requirements section was added to the policy (04/01/19). Providers must supply the required documentation at authorization; failure to provide requested records may result in denial.

Ensure history/physical, prior treatment documentation, severity assessments, and infusion-site justification are included.
If clinical criteria are not met or records are incomplete, an investigational or not medically necessary determination may be issued.

Note

Positioning Relative to Standard Therapies

Rituximab is positioned generally after inadequate response to standard therapies for many non-oncologic autoimmune indications (e.g., after TNF inhibitors in RA; after supportive therapy or other immunosuppressives in nephrology indications). Authorization should document prior standard therapies and reasons for selecting rituximab.

For RA, rituximab is used as second-line therapy in combination with methotrexate after failure of specified first-line biologics (see RA criteria and preferred adalimumab products).
For hematologic and autoimmune indications, document prior use of corticosteroids, IVIG, plasmapheresis, or other standard agents as applicable.

Step Therapy

Step Therapy Sequence and Requirements

Step therapy sequencing applies across indications where preferred alternatives exist. Rituximab is generally considered after failure or intolerance of first-line therapies; for some indications explicit step requirements (e.g., trials of preferred adalimumab products for RA or trial of cyclophosphamide for AAV induction) are part of authorization criteria.

For RA, the policy specifies preferred first-line biologics that must be tried and failed before second-line rituximab products are authorized; product lists and preferences have been updated over time—verify current preferred agents.
For transplant ABMR, step therapy may require prior trials of plasmapheresis, IVIG, and corticosteroids given limited comparative evidence for rituximab.

Step Therapy

ABMR Step Therapy Considerations

When ABMR is the indication, step therapy may require trials of plasmapheresis, IVIG, and corticosteroids before rituximab is authorized, given limited comparative evidence for rituximab in this setting. Provide detailed prior treatment history and clinical course.

Authorization requests for ABMR should include documentation of prior or concurrent plasmapheresis/PE, IVIG, corticosteroids, and response to these therapies.
Small retrospective studies and case series supporting rituximab for ABMR should be accompanied by center-specific protocols and justification.

Step Therapy

Step Therapy Relationship with Cyclophosphamide in AAV

For ANCA-associated vasculitis (AAV), cyclophosphamide remains a standard induction option; rituximab is preferred in specific populations (see guideline summaries). Step therapy and sequencing should reflect this relationship, and authorization should document contraindications or reasons cyclophosphamide is not appropriate when applicable.

Indications where rituximab is preferred include patients concerned about fertility, children/adolescents, frail older adults, relapsing disease, and PR3-ANCA-associated disease.
If cyclophosphamide was used previously and failed, documentation should be provided.

Step Therapy

Step Therapy for RA and Rituximab Sequencing

Step therapy for RA and rituximab sequencing: rituximab products (including biosimilars) are positioned as second-line agents after failure of specified first-line biologics and methotrexate. Recent updates to preferred adalimumab and rituximab product lists affect required trial sequencing—verify the current preferred product list when submitting an authorization.

Policy updates (2023–2026) have changed preferred/non-preferred status of multiple adalimumab and rituximab products; authorization must document trials of current preferred agents.
Riabni/Ruxience/Truxima are positioned relative to other rituximab products per the policy's product-preference rules.

Step Therapy

Step Therapy and Product Sequencing

Step therapy and product sequencing requirements have been updated over time and are captured in the policy history. Requests for non-preferred rituximab products must include documentation of prior trials consistent with the sequencing rules.

Policy history (see History section) documents the timing of product preference changes — authors should ensure the member's date of service falls under the applicable product status.
Non-formulary exceptions and product-specific trial requirements were revised in recent updates; confirm current requirements at time of request.

inv-75: Key safety concerns — boxed warnings summary

Boxed warnings — infusion reactionsFatal infusion reactions within 24 hours of infusion; ~80% of fatal reactions occurred with the first infusion

Boxed warnings — severe mucocutaneous reactionsSevere mucocutaneous reactions, some fatal

Boxed warnings — hepatitis B reactivationHepatitis B virus reactivation reported, some cases leading to fulminant hepatitis, hepatic failure, and death

Boxed warnings — PMLProgressive multifocal leukoencephalopathy (PML) resulting in death

inv-77: Immune tolerance induction (ITI) definition

DefinitionImmune tolerance induction (ITI) = increasing dose and frequency of factor infusions until inhibitor is undetectable and factor VIII levels normalize

Role in hemophiliaITI is the recommended first-line treatment for factor inhibitors in hemophilia; rituximab is an alternative or second-line option for nonresponders

Associated risks and outcomesITI success rate is low (~25%) and carries risks (anaphylaxis, nephrotic syndrome); immunosuppressive therapy is also a first-line eradication approach

inv-79: HLA sensitization definition

DefinitionHLA sensitization = presence of broadly reactive alloantibodies (eg, from prior pregnancy, transfusion, or transplant) that make donor matching difficult and increase risk of hyperacute rejection

AssessmentPanel reactive antibody (PRA) assays define level of sensitization and guide donor matching and desensitization strategies

Implication for transplantHLA-sensitized patients may undergo desensitization protocols (e.g., IVIG + plasmapheresis ± rituximab) to enable transplantation

inv-80: Antibody-mediated rejection (ABMR) definition

DefinitionAntibody-mediated rejection (ABMR) = immune injury to an allograft mediated by recipient antibodies, with or without complement deposition, endarteritis, and accelerated arteriosclerosis

Current therapiesTreatments include immunosuppression, plasmapheresis/PE, IVIG, corticosteroids, and antilymphocyte antibodies; rituximab evidence is limited to cohort and case series

Evidence statusData are retrospective or small; larger RCTs with longer follow-up are needed — evidence insufficient to confirm improved net health outcome

inv-81: iTTP (immune-mediated TTP) definition and role for rituximab

DefinitioniTTP (immune-mediated TTP) = TTP due to ADAMTS13 deficiency often with anti-ADAMTS13 antibodies; rituximab is suggested as an addition to corticosteroids and therapeutic plasma exchange for first acute events, relapses, and prophylaxis when ADAMTS13 activity remains low

Guideline recommendationsBCSH and ISTH recommend considering rituximab on admission with plasma exchange and corticosteroids for acute iTTP with neurologic/cardiac involvement and for refractory/relapsing disease; elective therapy can be considered when ADAMTS13 <5% in remission

Evidence baseEvidence includes phase II trial, cohorts, and case series showing reduced relapse rates versus historical controls

inv-82: ANCA-associated vasculitis (AAV) definition

DefinitionANCA-associated vasculitis (AAV) = autoimmune small-vessel vasculitis including granulomatosis with polyangiitis and microscopic polyangiitis

Role of rituximabRituximab plus glucocorticoids is recommended as an induction option for severe AAV in circumstances such as cyclophosphamide contraindication, fertility concerns, relapsing disease, or when further cyclophosphamide would exceed cumulative dose

Guideline sourcesNICE (2014) and KDIGO (2024) provide recommendations supporting rituximab for induction and maintenance in selected populations

inv-84: Guideline sources — list of authoritative guidelines cited

KDIGOKDIGO clinical practice guidelines (e.g., lupus nephritis 2024; AAV 2024)

NICENational Institute for Health and Care Excellence guidance (e.g., rituximab with glucocorticoids for AAV TA308, 2014)

BCSH and ISTHBritish Committee for Standards in Haematology (BCSH) and International Society on Thrombosis and Haemostasis (ISTH) guidelines for TTP

AAN, ASH, ISHLT, Myasthenia Gravis Foundation/Task ForceAmerican Academy of Neurology, American Society of Hematology, International Society for Heart and Lung Transplantation, Myasthenia Gravis Foundation guidance cited in policy references

inv-85: Rituximab biosimilars and products — multiple referenced products and preferred statuses

Riabni (rituximab-arrx)Referenced as a biosimilar product and noted as preferred in 2025 updates

Ruxience (rituximab-pvvr)Referenced as a rituximab biosimilar; formulary status updated across policy history

Truxima (rituximab-abbs)Referenced as a rituximab biosimilar with HCPCS code Q5115 listed

Rituxan HycelaRituxan with hyaluronidase (J9311) referenced separately and subject to sequencing rules vs biosimilars

HCPCS / coding notesHCPCS codes listed include J9312 (Rituxan 10 mg), J9311 (Rituxan Hycela), Q5115 (Truxima), Q5119 (Ruxience), Q5123 (Riabni) and J3590 referenced historically

2015-01-13policy_creation

New policy created with literature review through May 5, 2014, establishing coverage guidance for non-oncologic uses of rituximab.

2016-07-01annual_review

Annual review and reformatting; added medical necessity review criteria for site-of-service IV therapy and reorganized policy content.

2018-02-14interim_review

Interim review approved February 13, 2018 included updates to hospital outpatient coverage durations and coding additions (J9311/J9312 added earlier in 2019 updates).

2019-04-01administrative_update

Documentation Requirements section added (effective 04/01/19) to specify required medical record elements for prior authorization reviews.

2020-07-01annual_review

2020 annual review added Ruxience to site-of-service review and updated RA criteria (including addition of Rinvoq as a first-line option).

2021-02-01annual_review

2021 update added the biosimilar Riabni as a second-line agent and updated HCPCS coding (J3590 added then later replaced by Q5123).

2023-09-01annual_review

2023 review updated preferred adalimumab biosimilars to be tried prior to rituximab second-line use and adjusted preferred rituximab product statuses.

2024-01-01interim_review

2024 updates clarified preferred adalimumab product listings and changed Ruxience to preferred while making Rituxan and Rituxan Hycela non-preferred with required trials of preferred biosimilars prior to coverage.

2025-01-01policy_clarification

Policy clarified that preferred adalimumab product lists may not apply to specific custom formularies and noted applicability of FDA prescribing information; site-of-service exceptions and formulary notes were further updated through 2025.

2025-10-01interim_review

Interim reviews in 2025 updated product preferences (e.g., Cyltezo moved between preferred and non-preferred), added CRS site-of-service exception, and adjusted non-formulary exception authorization language effective with provider-notification periods.

2026-06-01annual_review_effective_updateLatest

Annual review approved May 12, 2026 with effective date 06/01/2026 updating RA criteria to prefer adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm and removing references to non-formulary exception reviews; reflects literature review through August 26, 2025.