Viva Health rituximab Prior Auth Policy Update

Coverage and Clinical Criteria

Initial Approval Criteria

Prior authorization validity is provided when the following conditions are met:

Initial Approval Requirements

Biosimilar prerequisite: Patient must have a contraindication, intolerance, or failure to Riabni®, Ruxience®, AND Truxima® prior to consideration of another rituximab product.
Age: Member is at least 18 years of age, unless otherwise specified.

Other universal requirements: Member does not have a severe active infection; AND member has been screened for hepatitis B (HBsAg and anti-HBc) prior to initiating therapy with monitoring for reactivation if current or prior infection; AND provider confirms no live vaccine within 28 days prior to starting treatment.

Non-oncology dosing

Covered dosing for non-oncology indications

Non-oncology dosing frequency: All other non-oncology indications (AIHA, SLE or LN, Myasthenia Gravis, NMOSD, Antisynthetase Syndrome-Related Interstitial Lung Disease, Idiopathic Membranous Nephropathy, Pediatric Idiopathic Nephrotic Syndrome): 400 billable units every 6 months.400 billable units every 6 months

See dosing tables for indication-specific induction regimens when applicable.

Exceptions / specific regimens: Some non-oncology indications have distinct initial or maintenance regimens (e.g., RA 200 units every 24 weeks; MS 200 units every 6 months; pemphigus initiation/maintenance schedules).See dosing limits by indication

Refer to indication-specific initial dosing limits for induction schedules.

Universal Criteria

Universal prerequisites for initial approval

Universal prerequisites: Member must have contraindication, intolerance, or failure to Riabni®, Ruxience®, AND Truxima®; member is at least 18 years of age unless otherwise specified; member does not have a severe active infection; member screened for HBV (HBsAg and anti-HBc) prior to therapy with monitoring for reactivation if evidence of current or prior infection; provider confirms no live vaccine within 28 days prior to starting treatment and live vaccines will not be administered concurrently while on treatment.

Oncology Indications

Oncology-specific requirement

Oncology indication requirement: Member is CD20 antigen expression positive (excluding specified uses such as chronic GVHD, hematopoietic cell transplantation conditioning, TA-TMA, KSHV-associated syndrome, and management of immune checkpoint inhibitor-related toxicities where CD20 testing is not required).

Pediatric B-AL

Pediatric Mature B-Cell Acute Leukemia

Pediatric B-AL: Member is at least 6 months of age; AND rituximab is used in combination with chemotherapy for previously untreated disease.

Adult ALL

Adult Acute Lymphoblastic Leukemia (ALL) criteria

ALL pathways: Either: member has Philadelphia chromosome–positive (Ph+) disease AND rituximab used in combination with MOpAD for TKI-refractory disease; OR member has Ph– disease AND rituximab used as a component of multiagent chemotherapy.

NCCN recommendations may apply to AYA (15–39 years) treated in adult or pediatric settings.

CNS Cancers

Central Nervous System cancers

CNS lymphoma uses: Indications include leptomeningeal metastases from lymphoma (intra-CSF administration), primary CNS lymphoma (induction or relapsed/refractory systemic IV therapy or intra-CSF if CSF positive), and consolidation (monthly maintenance) following CR/CRu. Permitted combinations include temozolomide, lenalidomide, methotrexate-containing regimens and high-dose methotrexate as specified.

Intra-CSF dosing and schedules are regimen-dependent; refer to NCCN for specifics.

CLL/SLL

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

CLL/SLL pathways: Multiple approved pathways: rituximab used in combination with fludarabine and cyclophosphamide; first-line with bendamustine when no del(17p)/TP53 and BTK/BCL2 inhibitors are not available; subsequent therapy options include bendamustine, idelalisib, lenalidomide, venetoclax; specific regimens include use with high-dose methylprednisolone for del(17p)/TP53 and regimens for Richter transformation as specified.

Refer to dosing limits for induction and renewal schedules.

Adult B-Cell Lymphomas

Adult B-Cell lymphomas and related

Adult B-cell lymphomas: Includes Burkitt lymphoma, diffuse large B-cell lymphoma, follicular and marginal zone lymphomas, mantle cell lymphoma, high-grade B-cell lymphomas, HIV-related B-cell lymphomas, and PTLD (treatment and prevention with EBV reactivation); rituximab used per disease-specific regimens and in combination as indicated.

Initial and renewal dosing limits documented in dosing tables.

Castleman Disease

Castleman disease

Castleman disease uses: Used for multicentric disease or unresectable/incompletely resected unicentric disease as first-line, alternate first-line, or subsequent therapy for relapsed/refractory/progressive disease.

Dosing per lymphoma/CASTLEMAN regimens; see dosing tables.

Pediatric Aggressive B-Cell Lymphomas

Pediatric aggressive mature B-cell lymphomas

Pediatric aggressive B-cell lymphoma: Member is at least 6 months of age and rituximab is used in combination with chemotherapy for listed histologies (primary mediastinal large B‑cell, DLBCL, Burkitt, Burkitt‑like) or for PTLD treatment/prevention with EBV reactivation.

AYA applicability may extend to patients up to 39 years treated in pediatric oncology settings.

Hairy Cell Leukemia

Hairy cell leukemia

Hairy cell leukemia uses: Rituximab may be used as single agent or in combination with cladribine or pentostatin for incomplete hematologic recovery or relapsed disease when purine analogs are not suitable; may be combined with vemurafenib or venetoclax in specified scenarios including initial therapy or relapse ≥2 years after initial therapy and progression after other therapies.

Refer to dosing limits for multi‑phase schedules.

Rosai-Dorfman Disease

Histiocytic neoplasms - Rosai-Dorfman Disease

Rosai-Dorfman Disease uses: Used as single agent for nodal disease, immune‑cytopenia, or IgG4‑related presentations for symptomatic unresectable unifocal disease, symptomatic multifocal disease, or relapsed/refractory disease.

Dosing examples include high HCPCS units every 6 months per dosing section.

Pediatric Hodgkin Lymphoma

Pediatric Hodgkin lymphoma

Pediatric Hodgkin: Member is ≤ 18 years of age (AYA applicability up to 39 in pediatric setting), has nodular lymphocyte‑predominant disease, and rituximab is used with CVbP as primary treatment for stage IA or IIA incomplete resection and non‑bulky disease.

Dosing per pediatric cycle schedules in dosage section.

Chronic GVHD

Chronic graft-versus-host disease (cGVHD)

cGVHD: Member is post‑allogeneic HCT (generally ≥3 months) and rituximab is used as additional therapy with systemic corticosteroids for steroid‑refractory disease.

Dosing and renewal limits may differ; see oncology renewal exceptions.

HCT Conditioning

Hematopoietic cell transplantation

HCT conditioning: Used as conditioning for allogeneic transplant as part of a non‑myeloablative regimen in combination with cyclophosphamide and fludarabine; dosing includes a pre‑transplant dose and post‑transplant doses as specified.

Refer to dosing section for exact per‑dose HCPCS units.

TA-TMA

Transplant-associated thrombotic microangiopathy (TA-TMA)

TA-TMA: Member is post‑HSCT; alternative diagnoses excluded; member has high‑risk disease defined by any of: random urine protein to creatinine ratio (rUPCR) ≥ 1; elevated serum sC5b‑9 > ULN; LDH ≥ 2 x ULN; concurrent grade II‑IV acute GVHD; concurrent infections; or clinical evidence of TA‑TMA organ dysfunction (excluding KDIGO stage I AKI).rUPCR ≥ 1; LDH ≥ 2 x ULN

No minimum age requirement.

Immune Checkpoint Inhibitor-Related Toxicities

Management of immune checkpoint inhibitor-related toxicities

ICI-related encephalitis: Member receiving immune checkpoint inhibitor therapy with encephalitis related to immunotherapy AND (autoimmune‑encephalopathy‑antibody positive OR limited/no improvement after 7–14 days on high‑dose corticosteroids ± IVIG).7–14 days

Bullous dermatitis/bullous pemphigoid: Used as additional therapy for severe (G3) or life‑threatening (G4) bullous dermatitis; for biopsy/serology‑confirmed bullous pemphigoid used as additional therapy for moderate (G2) disease.G2–G4

Hemolytic anemia: Used as additional therapy for hemolytic anemia related to immunotherapy for G3 disease if no response to corticosteroids after 5–7 days, or for G4 disease if no response after 3–5 days.3–7 days

Immune checkpoint inhibitor-related toxicities

Used for management of severe or steroid-refractory immune checkpoint inhibitor-related toxicities when specific conditions are met.

General requirement: Member has been receiving therapy with an immune checkpoint inhibitor.

Specific ICI toxicity pathways: See ICI‑related toxicity nodes for encephalitis, bullous dermatitis/pemphigoid, hemolytic anemia, thrombocytopenia, AKI, myositis, and myasthenia gravis with required steroid trial durations and antibody confirmation where indicated.

Non-oncology general restriction

General restriction for non-oncology indications

No concurrent therapies: Member is not on concurrent treatment with another CD20‑directed therapy, biologic agent, or targeted synthetic therapy for non‑oncology indications.

Concurrent CD20/biologic therapy may trigger denial.

Rheumatoid arthritis (RA)

Rheumatoid arthritis (RA) — coverage when ALL conditions are met

RA baseline and severity: Physician has assessed baseline disease severity with an objective tool AND documented moderate to severe active disease.

Combination therapy and prior csDMARD: Used in combination with methotrexate unless contraindicated/intolerant AND member tried and failed at least a 3‑month trial with ONE csDMARD OR member already established on biologic/targeted synthetic therapy.3 months

Examples: methotrexate, azathioprine, hydroxychloroquine, leflunomide, sulfasalazine.

TNF antagonist failure and rituximab washout: Previous failure with one or more TNF antagonists AND member has not had treatment with rituximab in the previous 4 months.4 months

Pemphigus vulgaris

Pemphigus vulgaris — coverage when ALL conditions are met

Diagnosis confirmation: Diagnosis supported by clinical features (lesions/blisters/Nikolsky sign), histopathologic confirmation by biopsy, AND positive direct immunofluorescence (DIF) OR presence of autoantibodies by IIF or ELISA.

Severity and concomitant therapy: Member has moderate to severe disease by an objective measure (e.g., PDAI, PSS, ABSIS) AND rituximab used in combination with glucocorticoids; other causes of blistering ruled out.

GPA/MPA

GPA/MPA — coverage for induction or maintenance

Age and diagnosis: Member is at least 2 years of age.>=2 years

Induction: Used as induction therapy in combination with glucocorticoids.

Maintenance: Used as maintenance therapy and may be used with or without glucocorticoids (per prescribing information and evidence for combination use).

Thrombocytopenic purpura / ITP

Thrombocytopenic purpura / ITP — coverage when ALL conditions are met

Diagnosis includes primary thrombocytopenia/ITP or Evans syndrome.

Prior steroid failure and bleeding risk: Member has previously failed or has contraindication/intolerance to corticosteroids AND is at increased risk for bleeding as indicated by platelet count < 30,000/mm^3 within the prior 28 days.<30,000/mm^3

TTP

Thrombotic Thrombocytopenic Purpura (TTP) — coverage when ALL conditions are met

Diagnosis and ADAMTS13: Member has immune‑mediated/acquired TTP with ADAMTS13 deficiency.

Use with TPE: Used in combination with corticosteroids and therapeutic plasma exchange (TPE) OR used as single‑agent prophylactic therapy in remission per clinical scenario.

Multiple sclerosis (MS)

Multiple sclerosis (MS) — coverage when ALL conditions are met

Diagnosis confirmation: Confirmed diagnosis of MS documented by laboratory report (e.g., MRI).

Relapsing form: Member has a relapsing form of MS (RRMS, active SPMS, or CIS).

Autoimmune hemolytic anemia (AIHA)

Autoimmune hemolytic anemia (AIHA) — coverage when ANY of the following are met

Warm AIHA: Member has warm‑reactive AIHA refractory to or dependent on glucocorticoids.

Cold agglutinin disease: Member has cold agglutinin disease with symptomatic anemia, transfusion dependence, or disabling circulatory symptoms.

Systemic lupus erythematosus (SLE) without active lupus nephritis

Systemic lupus erythematosus (SLE) without active lupus nephritis — coverage when ALL conditions are met

Diagnosis and exclusions: Active SLE WITHOUT active lupus nephritis AND member does not have severe active CNS lupus.

Prior hydroxychloroquine: Member has tried and had inadequate response to hydroxychloroquine OR has intolerance/hypersensitivity OR an FDA contraindication.

Prior corticosteroid or immunosuppressive agent: Member has tried and had inadequate response to ONE corticosteroid OR immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR has intolerance/contraindication.

Concomitant standard therapy: Member is currently treated with and will continue standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide).

Lupus Nephritis (LN)

Lupus Nephritis (LN) — coverage when ALL conditions are met

Diagnosis and biopsy class: Active lupus nephritis with class III, IV, or V disease confirmed via kidney biopsy.Class III/IV/V

Background therapy: Member will be using background immunosuppressive LN therapy (corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) in combination.

CNS lupus and combination rules: Member does not have severe active CNS lupus AND combination immunomodulatory agent rules same as SLE (prescribing info and evidence required).

Myasthenia gravis (MuSK-positive)

Myasthenia gravis (MuSK-positive) — coverage when ALL conditions are met

MuSK antibody positive: Member has MuSK‑antibody positive disease.

Refractory disease: Member is refractory to standard first‑line therapy (glucocorticoids, azathioprine, mycophenolate, etc.).

Complications of transplanted solid organ

Complications of transplanted solid organ — coverage when ANY of the following are met

Pre-transplant suppression: Used for suppression of panel reactive anti‑HLA antibodies prior to transplantation.

Applies to adult and pediatric members; no minimum age.

Antibody‑mediated rejection: Used for treatment of antibody‑mediated rejection of solid organ transplantation.

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder (NMOSD) — coverage when ALL diagnostic criteria are met

AQP4‑seropositive pathway: Member is seropositive for AQP4‑IgG AND has at least one core clinical characteristic AND alternative diagnoses excluded.

Core characteristics and MRI requirements are specified in policy.

Seronegative pathway: Member is seronegative or AQP4 status unknown AND has at least two core clinical characteristics from one or more clinical attacks AND has met MRI typical findings for affected areas AND alternative diagnoses excluded.

Therapy setting: Used as single agent or in combination with immunosuppressive therapy (azathioprine, methotrexate, mycophenolate, etc.).

Antisynthetase syndrome-related interstitial lung disease

Antisynthetase syndrome-related interstitial lung disease — coverage when ALL criteria are met

Antibody positivity: Member has antisynthetase antibody‑positive disease (e.g., anti‑Jo‑1, PL‑7, PL‑12, OJ, EJ, etc.).

Baseline assessment: Physician has assessed baseline disease severity with objective measures (baseline glucocorticoid use, PFTs [FVC%, TLC%, DLCO%], or chest CT).

Severity and refractory disease: Member has documented severe active disease AND recurrent or progressive disease despite glucocorticoids and/or other immunosuppressive agents.

Combination therapy: Will be used in combination with glucocorticoids or other immunosuppressive agents unless contraindicated or intolerant.

Idiopathic (primary) membranous nephropathy

Idiopathic (primary) membranous nephropathy — coverage when ALL or ANY criteria are met as specified

Diagnosis and exclusion: Documented idiopathic (primary) membranous nephropathy AND secondary causes ruled out (infections, autoimmune disease, malignancy, supplements, NSAIDs, etc.).

First‑line eligibility: Used as first‑line therapy in members with any moderate‑to‑high risk factor: proteinuria >3.5 g/day with <50% decrease after 6 months ACEi/ARB; OR eGFR <60 ml/min/1.73 m^2; OR proteinuria >8 g/day for >6 months; OR serious nephrotic complications (AKI, infection, thromboembolism).see node

Relapse or resistance: Used for initial disease relapse after remission on first‑line therapy (rituximab, calcineurin inhibitor, or cyclophosphamide+glucocorticoids) OR for treatment‑resistance to those agents; additional conditions include stable eGFR and use with calcineurin inhibitor if previously treated with rituximab alone.

Antisynthetase Syndrome-Related ILD

Antisynthetase Syndrome-Related Interstitial Lung Disease — alternate presentation

Antisynthetase ILD criteria: Member has antisynthetase antibody positive disease; physician assessed baseline disease severity using objective measures (baseline glucocorticoid use, PFTs or chest CT); member has severe active disease and recurrent or progressive disease despite glucocorticoids/other immunosuppressives; agent will be used in combination with glucocorticoids or other immunosuppressive agents unless contraindicated or intolerant.

Idiopathic (Primary) Membranous Nephropathy

Idiopathic (Primary) Membranous Nephropathy — first‑line or subsequent therapy conditions

Diagnosis and exclusion: Member has idiopathic membranous nephropathy and secondary causes have been ruled out.

First‑line therapy eligibility: First‑line therapy allowed for members with at least one moderate/high risk factor (proteinuria >3.5 g/day with <50% reduction after 6 months ACEi/ARB; eGFR <60; proteinuria >8 g/day for >6 months; serious nephrotic complications).

Relapse/treatment‑resistance: Used for relapse after remission on first‑line therapy or treatment‑resistance to first‑line agents; if previously treated with rituximab alone in first‑line, subsequent therapy should be combined with a calcineurin inhibitor and member should have stable eGFR; post‑transplant recurrence requires proteinuria >1 g/day.

Pediatric Idiopathic Nephrotic Syndrome

Pediatric Idiopathic Nephrotic Syndrome — coverage when ALL conditions are met

Pediatric nephrotic syndrome criteria: Member is ≤ 12 years of age; AND has symptomatic nephrotic‑range proteinuria with hypoalbuminemia or edema; AND diagnosed with FRNS, SDNS, or SRNS as defined; AND has failed an adequate trial with at least one other steroid‑sparing agent (cyclophosphamide, calcineurin inhibitor, mycophenolate, etc.).

IgG4-Related Disease (IgG4-RD)

IgG4‑Related Disease (IgG4‑RD) — coverage when ALL conditions are met

IgG4‑RD criteria: Confirmed diagnosis of IgG4‑RD by exam, imaging, labs, or pathology; other mimicking conditions ruled out; member experiencing a flare requiring corticosteroids AND disease refractory to corticosteroids or contraindication/intolerance to steroids; member at high risk for recurrent flares (history in ≥2 organs/sites); AND at least one specified organ is affected (pancreas, bile ducts, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, sinonasal tract, thyroid).

Wiskott-Aldrich Syndrome (pretreatment use)

Wiskott‑Aldrich Syndrome (pretreatment use) — coverage when ALL conditions are met

WAS pretreatment: Used as pretreatment prior to infusion of etuvetidigene autotemcel to deplete autoreactive B‑cells OR as pre‑emptive treatment for potential EBV‑related lymphoproliferative disorder.

Renewal / response criteria across indications

Renewal and continued coverage require evidence of clinical benefit and monitoring as specified per condition

Universal renewal: Member continues to meet universal and indication‑specific criteria including concomitant therapy requirements and performance status; duration of authorization not exceeded; AND absence of unacceptable toxicity (examples listed: severe infusion reactions, TLS, severe mucocutaneous reactions, PML, HBV reactivation, serious infections, cardiovascular events, renal toxicity, bowel perforation).

Oncology response: For oncology indications, member has not exceeded dosing/duration limits and demonstrates treatment response/stabilization by CBC, bone marrow cytogenetics, QPCR, FISH, or tumor size reduction.

RA response: For RA, disease response indicated by improved tender/swollen joint counts, CRP reduction, patient global assessment improvement, or validated scoring tool improvement (e.g., DAS28 improvement ≥1.2 or ACR20 ≥20%).

ITP response:

SLE Renewal Criteria

SLE renewal — renewal covered when member has experienced clinical benefit and continues background therapy

SLE renewal: Member has experienced clinical benefit with the requested agent; AND member is currently treated with and will continue standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide).

Lupus Nephritis Renewal Criteria

Lupus nephritis renewal — renewal specifics

Lupus nephritis renewal: Member has experienced clinical benefit with the requested agent; prior authorization may only be renewed in members experiencing disease relapse (e.g., increased serum creatinine, increased urine protein excretion, decreased eGFR).

Myasthenia Gravis Response Criteria

Myasthenia gravis response — response requirements for continuation

Myasthenia gravis response: Disease response indicated by a decrease in the daily dose of corticosteroids and/or improvement in signs and symptoms compared to baseline.

Applies to MG unrelated to immunotherapy‑related toxicity.

NMOSD Response Criteria

NMOSD response — renewal and continuation criteria

NMOSD response: Stabilization or improvement in any of: decrease in acute relapses or improved stability; reduced hospitalizations; reduction/discontinuation in plasma exchange treatments; reduction/discontinuation of corticosteroids without relapse.

Antisynthetase Syndrome-Related Interstitial Lung Disease Criteria

Antisynthetase Syndrome-Related ILD response — response criteria

Antisynthetase ILD response: Stabilization or improvement in any of: reduction/stabilization of glucocorticoid use from baseline; improvement/stabilization in PFTs (improvement >10% increase in FVC%, TLC%, or DLCO%; stabilization defined as <10% decrease); improvement/stabilization in chest CT score (improvement >10% decrease; stabilization <10% increase).

Idiopathic Membranous Nephropathy Criteria

Idiopathic Membranous Nephropathy — response/renewal criteria

Membranous nephropathy coverage: Member experienced beneficial disease response with improvement in symptoms and/or objective measures (reduction in proteinuria, normalization of serum albumin, improvement/stability of serum creatinine/eGFR, decrease in anti‑PLA2R levels); OR member has resistant disease following first‑line rituximab AND member has stable eGFR AND will be used in combination with a calcineurin inhibitor if previously treated with rituximab alone.

Pediatric Idiopathic Nephrotic Syndrome Criteria

Pediatric Idiopathic Nephrotic Syndrome — renewal/response criteria

Pediatric nephrotic recurrence: Member previously achieved beneficial response from prior course AND is experiencing recurrent active disease necessitating additional doses defined as nephrotic‑range proteinuria (dipstick ≥3+ (>300 mg/dL) for 3 consecutive days OR UPCR ≥200 mg/mmol (≥2 mg/mg) on spot urine on 3 consecutive days), with or without reappearance of edema.dipstick and UPCR criteria

IgG4-Related Disease Criteria

IgG4‑Related Disease — response criteria for continuation

IgG4‑RD response: Disease response indicated by one or more of: reduction in corticosteroid requirement for flares from baseline; reduction in IgG4‑RD flares; stabilization/improvement in symptoms, exam findings, imaging, labs, and/or pathology in involved organs compared to baseline.

Multiple Sclerosis — maintenance dosing

Multiple Sclerosis — maintenance dosing guidance

MS maintenance dosing: Goal maintenance dose: 500 mg IV every 12 months; dose decrease by no more than 500 mg OR interval increase by no more than 6 months.500 mg every 12 months

Guidance only; consider member‑specific variables.

Diagnosis-based coverage requirement

Diagnosis-based coverage requirement — covered when ALL of the following are met

Diagnosis must be listed: The member has one of the ICD‑10 diagnosis codes listed in Appendix 1 (policy appendix).ICD‑10 code present in claim/authorization

Appendix lists permissible covered diagnoses for the policy.

Prior authorization for oncology indications is initially valid for 180 days. Certain pediatric oncology uses and select transplant-related complications are considered non-renewable under this policy and therefore will not receive successive authorizations beyond the initial approval period (examples include pediatric B‑cell acute leukemia induction/consolidation, pediatric aggressive mature B‑cell lymphomas, pediatric Hodgkin lymphoma, KSHV‑associated inflammatory cytokine syndrome, HCT, and TA‑TMA). For non‑oncology uses the usual initial prior authorization period is also 180 days, with a subset of conditions (pemphigus vulgaris, systemic lupus erythematosus, lupus nephritis) eligible for an initial 365‑day authorization; renewal intervals and renewal permissibility vary by indication and are specified in the applicable condition‑specific sections.

For oncology indications the policy requires demonstration of CD20 antigen expression positive disease. This CD20 requirement does not apply to a small number of specified oncology‑adjacent uses — notably chronic graft‑versus‑host disease (cGVHD), hematopoietic cell transplantation (HCT) conditioning or related uses, transplant‑associated thrombotic microangiopathy (TA‑TMA), KSHV‑associated inflammatory cytokine syndrome, and management of certain immune checkpoint inhibitor–related toxicities — which are specifically excluded from the CD20 expression requirement.

For all non‑oncology indications, concurrent therapy with another CD20‑directed agent, a biologic agent, or a targeted synthetic therapy is not permitted. Prior authorization requests that document overlapping administration of a separate CD20‑directed monoclonal antibody or concurrent biologic/targeted synthetic therapy risk denial under this policy.

Coverage for idiopathic (primary) membranous nephropathy requires that secondary causes be excluded. Cases in which secondary etiologies (for example, infections, other autoimmune diseases, malignancy, certain supplements or NSAID exposures) have not been ruled out are explicitly excluded from the idiopathic membranous nephropathy criteria and are not supported for authorization under this section.

When membranous nephropathy is being considered for additional rituximab‑based therapy after prior first‑line rituximab, the policy requires that the member have a stable eGFR and that subsequent treatment be administered in combination with a calcineurin inhibitor if the patient previously received rituximab alone in the first‑line setting. Documentation of prior rituximab use and the planned combination approach must be provided to support continued therapy.

This portion of the policy supports only the diagnoses and clinical scenarios listed in Appendix 1. Diagnoses not included in that appendix are not supported as covered indications under this section and prior authorization requests must be submitted with an applicable ICD‑10 code from the listed appendix to be considered.

Codes, Units, and Diagnosis Lists

HCPCS CodesHCPCSCovered

J9312	Injection, rituximab, 10 mg; 1 billable unit = 10 mg (Rituxan IV only)
Q5115	Injection, rituximab-abbs, biosimilar (Truxima), 10 mg; 1 billable unit = 10 mg
Q5119	Injection, rituximab-pvvr, biosimilar (Ruxience), 10 mg; 1 billable unit = 10 mg
Q5123	Injection, rituximab-arrx, biosimilar (Riabni), 10 mg; 1 billable unit = 10 mg

HCPCS Billable-Unit Definitionmixed

Unit	1 billable unit = 10 mg for listed rituximab HCPCS codes

Dosing Units (Common per-dose examples)mixed

Example

100 billable units = 1000 mg; 130 billable units = 1300 mg; 190 billable units = 1900 mg; 250 billable units = 2500 mg; 400 billable units = 4000 mg; 780 billable units = 7800 mg; 800 billable units = 8000 mg

Rituximab and Biosimilar HCPCS CodesHCPCSCovered

J9312	Rituximab (Rituxan)
Q5115	Rituximab-abbs (Truxima)
Q5119	Rituximab-pvvr (Ruxience)
Q5123	Rituximab-arrx (Riabni)

HCPCS codes (duplicate listing)HCPCS

J9312	Injection, rituximab, 10 mg
Q5115	Rituximab-abbs, 10 mg
Q5119	Rituximab-pvvr, 10 mg
Q5123	Rituximab-arrx, 10 mg

NDCs for Rituximab and BiosimilarsNDCCovered

50242-0051-xx	Rituxan 100 mg/10 mL single-dose vial
50242-0053-xx	Rituxan 500 mg/50 mL single-dose vial
63459-0103-xx	Truxima 100 mg/10 mL single-dose vial
63459-0104-xx	Truxima 500 mg/50 mL single-dose vial
00069-0238-xx	Ruxience 100 mg/10 mL single-dose vial
00069-0249-xx	Ruxience 500 mg/50 mL single-dose vial
55513-0224-xx	Riabni 100 mg/10 mL single-dose vial
55513-0326-xx	Riabni 500 mg/50 mL single-dose vial

Covered ICD-10 Codes (selected lymphomas: C83-C85, C88, C91)ICD-10Covered

C83.19	Other small cell B-cell lymphoma, extranodal and solid organ sites
C83.30	Diffuse large B-cell lymphoma, unspecified site
C83.31	Diffuse large B-cell lymphoma, lymph nodes of head, face and neck
C83.32	Diffuse large B-cell lymphoma, intrathoracic lymph nodes
C83.33	Diffuse large B-cell lymphoma, intra-abdominal lymph nodes
C83.34	Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb
C83.35	Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.36	Diffuse large B-cell lymphoma, intrapelvic lymph nodes
C83.37	Diffuse large B-cell lymphoma, spleen
C83.38	Diffuse large B-cell lymphoma, lymph nodes of multiple sites

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Covered ICD-10 Codes (Selected hematologic, autoimmune, and neurologic diagnoses)ICD-10Covered

D47.Z1	Monoclonal gammopathy, unspecified
D47.Z2	Monoclonal gammopathy of undetermined significance
D59.0	Autoimmune hemolytic anemia
D59.2	Other hemolytic anemias
D59.10	Warm autoimmune hemolytic anemia, unspecified
D59.11	Postinfectious autoimmune hemolytic anemia
D59.12	Drug-induced autoimmune hemolytic anemia
D59.13	Cold agglutinin disease
D59.19	Other autoimmune hemolytic anemias
D69.3	Immune thrombocytopenic purpura

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Covered ICD-10 Diagnosis Codes (Appendix 1 continued - comprehensive list)ICD-10Covered

M05.10	Rheumatoid arthritis with rheumatoid factor, multiple sites
M05.111	Rheumatoid arthritis with rheumatoid factor of right shoulder
M05.112	Rheumatoid arthritis with rheumatoid factor of left shoulder
M05.119	Rheumatoid arthritis with rheumatoid factor of unspecified shoulder
M05.121	Rheumatoid arthritis with rheumatoid factor of right elbow
M05.122	Rheumatoid arthritis with rheumatoid factor of left elbow
M05.129	Rheumatoid arthritis with rheumatoid factor of unspecified elbow
M05.131	Rheumatoid arthritis with rheumatoid factor of right wrist
M05.132	Rheumatoid arthritis with rheumatoid factor of left wrist
M05.139	Rheumatoid arthritis with rheumatoid factor of unspecified wrist

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Covered ICD-10 Diagnosis Codes (Appendix 1 continued)ICD-10Covered

M05.821	Other rheumatoid arthritis with rheumatoid factor of right elbow
M05.822	Other rheumatoid arthritis with rheumatoid factor of left elbow
M05.829	Other rheumatoid arthritis with rheumatoid factor of unspecified elbow
M05.831	Other rheumatoid arthritis with rheumatoid factor of right wrist
M05.832	Other rheumatoid arthritis with rheumatoid factor of left wrist
M05.839	Other rheumatoid arthritis with rheumatoid factor of unspecified wrist
M05.841	Other rheumatoid arthritis with rheumatoid factor of right hand
M05.842	Other rheumatoid arthritis with rheumatoid factor of left hand
M05.849	Other rheumatoid arthritis with rheumatoid factor of unspecified hand
M05.851	Other rheumatoid arthritis with rheumatoid factor of right hip

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What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required for all indications described in this policy. Providers must submit a PA request that documents the diagnosis (use an applicable ICD-10 code from Appendix 1), the specific HCPCS/HCPCS-level product code(s) to be used, the planned dosing regimen and clinical rationale for that dosing, and supporting clinical documentation as described below. PA requests for non-oncology indications must demonstrate that indication-specific criteria are met.

Include the HCPCS code (e.g., J9312, Q5115, Q5119, Q5123) and dosing justification with the request; claims billed with codes that do not match the authorized HCPCS may be denied.
For Medicare Part B members, verify applicable NCD/LCD/LCA(s) prior to submitting (see CMS Medicare coverage database).

Prior Authorization

Renewal Limits and Exceptions

Prior authorization validity: Initial authorizations are generally provided for 6 months (180 days) for both oncology and non-oncology indications unless otherwise specified. Certain non-oncology indications (pemphigus vulgaris, systemic lupus erythematosus, lupus nephritis) receive an initial 12-month (365 days) authorization. Renewal intervals vary by indication (typically every 6 months) and some indications have specific renewal rules or maximum dose/duration limits (see items).

Definitions, Background, and Context

Scope: This policy addresses intravenous, intrathecal, and intraventricular formulations of rituximab and its biosimilars for a broad range of oncology and non‑oncology indications. It defines initial authorization prerequisites (including biosimilar trial requirements and hepatitis B screening), dosing limits and example regimens, and renewal/continuation rules that require objective evidence of clinical benefit. Where specified, initial authorizations are typically 180 days (with some non‑oncology indications eligible for an initial 365‑day approval); renewals are generally every 180 days unless the condition‑specific section specifies otherwise.

Prior authorization prerequisite definition — must trial specified biosimilars before other rituximab products

Biosimilar trial prerequisite for PAPatient must have documented contraindication, intolerance, or failure to Riabni®, Ruxience®, AND Truxima® before other rituximab products are considered

Documentation requiredPA requests must document prior trial/failure/intolerance to the three named biosimilars

Denial riskLack of documented failure/intolerance to these biosimilars may result in PA denial

Initial Dosing Limits and Regimens

Initial dosing limits by indication

Initial dosing limits by indication — HCPCS billable units examples

CLL/SLL initial: Initial: 100 billable units x 1 dose, then 130 billable units every 7 days x 11 doses; renewal therapy: 130 billable units every 8 weeks.

ALL initial: 100 billable units twice weekly (per ALL dosing schedules).

Waldenström initial: 100 billable units every 7 days x 12 doses; renewal: 400 billable units every 6 months.

B‑Cell lymphoma initial: 100 billable units every 7 days x 8 doses in a 6‑month period; renewal: 400–800 billable units every 6 months per subtype.

Renewal and Maintenance Criteria

Continuation therapy

Continuation therapy — requires evidence of continued benefit and absence of unacceptable toxicity

Continuation requirements: Member continues to meet universal and indication‑specific criteria; duration limits not exceeded; absence of unacceptable toxicity (examples listed in renewal criteria).

Oncology continuation limited by dosing/duration caps.

Maintenance / Continuation Therapy

Maintenance / Continuation Therapy — maintenance dosing guidance per indication

Rheumatoid arthritis maintenance: Goal maintenance dose: 500 mg IV every 6 months; dose decrease by no more than 500 mg upon renewal following ≥12 months sustained remission and stability.>=12 months sustained remission for adults to consider dose reduction

Step Therapy and Sequencing Requirements

Step	Requirement	Coverage label
1	Member must trial or have documented contraindication, intolerance, or failure to the three listed rituximab biosimilars (Riabni®, Ruxience®, and Truxima®) prior to consideration of another rituximab product.	Requires biosimilar trial before other rituximab products

Step	Requirement	Coverage label
1	Prior authorization requires documented contraindication, intolerance, or therapeutic failure to Riabni®, Ruxience®, AND Truxima® before approving another rituximab product.	Prior contraindication/intolerance/failure to Riabni, Ruxience, AND Truxima required

Step	Documentation required	Coverage label
1	Document prior trials of indicated therapies and provide objective evidence of inadequate response, intolerance, or contraindication (examples: failed steroid-sparing agent in pediatric nephrotic syndrome; failed ACEi/ARB with persistent proteinuria for membranous nephropathy; prior biosimilar trials per policy).	Documented prior trials and inadequate response/intolerance required

Step	Membranous nephropathy sequencing requirement	Coverage label
2	If member previously received rituximab alone in first-line for idiopathic membranous nephropathy and has resistant disease, subsequent rituximab-based therapy must be given with a calcineurin inhibitor and member must have stable eGFR.	Combine with calcineurin inhibitor after prior rituximab first-line failure

Topic	Summary	Coverage label
Comparative biosimilar evidence	Multiple randomized trials and pharmacokinetic studies comparing rituximab biosimilars (e.g., CT‑P10 and others) with innovator rituximab are cited in the evidence base; these references support biosimilar efficacy and safety but the policy imposes a biosimilar trial requirement before other rituximab products are considered.	Comparative biosimilar evidence summarized (no explicit additional step)

Quantity Limits and Unit Conversions

Rituximab products — example billable units vary by indication (100, 130, 190, 250, 400, 780 units)

Example billable HCPCS units vary by indicationExamples shown in dosing tables include 100, 130, 190, 250, 400, and 780 billable units depending on indication

Unit definitionHCPCS billable unit = 10 mg per listed HCPCS code (see coding tables)

Common per‑dose examples100 units commonly used for many induction regimens; 400 units commonly used for many non‑oncology maintenance 6‑month dosing

rituximab (non-oncology indications) — commonly 400 billable units per 6 months

Common non‑oncology dosing quantity400 billable units every 6 months for most non‑oncology indications

ContextApplies to indications such as AIHA, SLE/LN, Myasthenia Gravis, NMOSD, Antisynthetase ILD, Idiopathic Membranous Nephropathy, Pediatric Idiopathic Nephrotic Syndrome

Administration Setting

Note

Administer in appropriate infusion setting (hospital outpatient/infusion center/office)

Hospital outpatient, infusion center, or office settings are appropriate administration sites per indication-specific dosing; note transplant-related suppression and antibody-mediated rejection uses in hospital outpatient context.

Billing Rule

Document planned administration setting with PA

IV administration settings include infusion center, hospital outpatient, or office depending on indication and route (intravenous; intrathecal/intraventricular dosing noted for some CNS indications).

Biosimilar Preferences and Evidence

Step Therapy

Document trials of Riabni®, Ruxience®, and Truxima® before other products

Policy reiterates the requirement to trial Riabni®, Ruxience®, and Truxima® (biosimilars) prior to consideration of other rituximab products; ensure documentation of those trials is included.

Billing Rule

Use appropriate HCPCS Q-codes for biosimilars (Q5115, Q5119, Q5123)

HCPCS Q-codes for rituximab and biosimilars are listed in the policy (Q5115, Q5119, Q5123) alongside the reference product code and should be used when appropriate.

Billing Rule

Select the correct HCPCS code for the administered rituximab product

The reference product and biosimilars are listed with distinct HCPCS codes (including J9312 for the reference product); select the correct code for the product administered.

References and Guideline Citations

The prior authorization criteria and clinical guidance in this policy are informed by product labeling and a broad set of published sources and guidelines, including the rituximab and biosimilar package inserts, NCCN guideline derivatives and compendia, and peer‑reviewed literature across hematology, rheumatology, nephrology, neurology, transplant, and dermatology. Representative supporting references cited in the policy include the Rituxan, Truxima, Ruxience, and Riabni package inserts and multiple randomized trials, systematic reviews, and specialty society guidance documents (see the References section for the full bibliography).

The policy cites comparative clinical trials and bibliographic entries evaluating rituximab and proposed biosimilars (for example, the JASMINE trial and other randomized studies) to support statements about biosimilar comparability and to inform payer considerations. These trial citations are listed in the References section accompanying the policy.

The policy bibliography compiles product labeling, randomized trials, systematic reviews, specialty society guidelines (NCCN, ACR, EULAR, ASH, etc.), and other peer‑reviewed literature across the covered disease areas. Providers are directed to the References section for the complete citation list that underpins the condition‑specific coverage criteria and dosing guidance.

Policy Revision History

Date of Origin: 7/20/2010policy_origin

Policy originated (Date of Origin).

Last Review Date: 04/01/2026last_reviewLatest

Most recent full policy review completed and document updated with last review date.

OpenPayer

Rituximab: Riabni®, Rituxan®, Ruxience®, Truxima® (Intravenous/Intrathecal/Intraventricular)

Coverage and Clinical Criteria

Codes, Units, and Diagnosis Lists

What Providers Must Do

Definitions, Background, and Context

Initial Dosing Limits and Regimens

Renewal and Maintenance Criteria

Step Therapy and Sequencing Requirements

Quantity Limits and Unit Conversions

Administration Setting

Biosimilar Preferences and Evidence

References and Guideline Citations

Policy Revision History