Medical policy governing prior authorization, coverage criteria, and authorization lengths for intravenous rituximab products for EmblemHealth members (Commercial and Medicaid are detailed; Medicare referenced separately). Affects providers requesting rituximab infusions and pharmacy/infusion administrators.
Change TypeMultiple additions, clarifications, and operational updates
Effective Date
Next Review DateOct 29, 2024
Key ActionObtain prior authorization and document HBV screening (HBsAg and anti-HBc) before initiating therapy; trial of preferred biosimilars Ruxience AND Truxima is required for new starts of Rituxan or Riabni unless clinically justified.
Updated length of authorization and dosage chart; Added Medicare NCD/LCD Statement.
Added multiple new indications and criteria including Adult ALL, Hairy Cell Leukemia, Histiocytic Neoplasms (Rosai-Dorfman), Pediatric Hodgkin Lymphoma, Hematopoietic Cell Transplantation, and many autoimmune and transplant-related indications.
Renewal rules were updated for multiple indications (e.g., Adult ALL max 18 doses; some oncology and transplant indications may NOT be renewed).
Non-oncology indications clarified that patients must not be on concurrent CD20-directed therapy, TNF-inhibitor, IL-inhibitor, or listed biologic/non-biologic agents.
Added Extranodal Marginal Zone Lymphoma (EMZL) of the Stomach & Nongastric Sites (Noncutaneous) to initial criteria.
Management of immunotherapy-related toxicities criteria updated to add cemiplimab and other checkpoint inhibitors and to change steroid-refractory timing to limited to no improvement after 7 to 14 days of pulse-dose corticosteroids with or without IVIG.
Pemphigus vulgaris criteria revised to require positive direct immunofluorescence (DIF) microscopy result or ELISA (removed 'indirect').
Added statement that coverage may NOT be renewed for certain indications and removed renewal language based on patient-reported or clinician assessments.
Updated Truxima indications to include pediatric patients 2 years and older for GPA and MPA in combination with glucocorticoids.
Added and updated biosimilar agents (Ruxience, Truxima, Riabni) and related Q-codes; established Ruxience and Truxima as preferred agents with step therapy requiring trial of both before Rituxan for Commercial and Medicaid (effective 07/01/2020).
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
6 monthsStandard initial authorization length
12 monthsPemphigus initial auth length
Ruxience, TruximaPreferred biosimilars
Rituxan, RiabniNon-preferred products
RequiredHBV screening
07/01/2020Step therapy effective
Coverage Criteria and Indications
Commercial/Medicaid Initial Coverage Criteria
For Commercial and Medicaid members, coverage is provided when ALL of the following are met (in addition to applicable NCCN-supported uses):
Commercial/Medicaid initiation criteria: 1) Patient must be screened for HBV infection (HBsAg and anti-HBc) prior to initiating therapy; 2) For newly started Rituxan or Riabni, patient has experienced therapeutic failure or intolerance with plan-preferred medications (Ruxience AND Truxima) OR non-preferred is requested for an indication not FDA-approved or not supported by NCCN; 3) Patient is at least 18 years of age unless otherwise specified; 4) Patient has not received a live vaccine within 28 days prior to starting treatment and live vaccines will not be administered concurrently while on treatment.
NCCN-supported uses with category 1 or 2A are included; separate Medicare LCD/NCD criteria apply for Medicare members.
Oncology Indications
Oncology-specific requirement:
Oncology indication requirement: Patient is CD20-positive (excluding use for cGVHD, Hematopoietic Cell Transplantation, and Management of Immunotherapy-Related Toxicity).
Applies to oncology indications only.
Covered indications and criteria
Covered when ALL of the following are met for newly started rituximab (Rituxan or Riabni) unless otherwise specified:
General preconditions: Patient screened for HBV infection (HBsAg and anti-HBc) prior to initiating therapy; patient is at least 18 years of age unless otherwise specified; patient has not received a live vaccine within 28 days prior to starting treatment and live vaccines will not be administered concurrently while on treatment.
Agent preference/step therapy: For newly started Rituxan or Riabni therapy, coverage may be considered medically necessary when EITHER A) patient has experienced therapeutic failure or intolerance with plan-preferred medications (Ruxience AND Truxima); OR B) Rituxan or Riabni is requested for an indication for which the plan-preferred biosimilars have not been FDA-approved OR are not supported by NCCN Guidelines/Compendium at category 1 or 2A.
Oncology: CD20 requirement: Patient is CD20-positive (excluding use for cGVHD, hematopoietic cell transplantation, and management of immunotherapy-related toxicity).
Rheumatoid arthritis (RA)
Covered when ALL of the following are met
RA coverage: 1. Medication must be requested by a Rheumatologist; 2. Adult patient (≥18 years); 3. Documented moderate to severe disease; 4. Must be used in combination with methotrexate unless contraindicated or intolerant; 5. Patient tried and failed at least a 3-month trial with ONE oral DMARD (examples listed); 6. Previous failure with one or more preferred TNF antagonists, at least one of which should be a self-injectable; 7. Baseline disease severity assessed with objective measure/tool; 8. No treatment with Rituxan, Riabni, Ruxience, or Truxima in previous 4 months; Note: patients already established on biologic therapy are exempt from oral DMARD trial requirement.
Pemphigus vulgaris
Covered when ALL of the following are met
Pemphigus vulgaris coverage: 1. Adult patient (≥18 years); 2. Diagnosis confirmed by (A) clinical features and (B) histopathologic confirmation by biopsy AND (C) positive direct immunofluorescence (DIF) microscopy result OR presence of autoantibodies detected by DIF or ELISA; 3. Moderate to severe disease by objective tool (PDAI, PSS, ABSIS); 4. Patient is on combination glucocorticoid therapy; 5. Other blistering/erosive diseases ruled out.
Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Covered when ALL of the following are met
GPA/MPA coverage: 1. Patient age ≥2 years (adult and pediatric); 2. Used in combination with glucocorticoids.
Thrombocytopenic purpura
Covered when ALL of the following are met
Thrombocytopenic purpura coverage: 1. Diagnosis: primary thrombocytopenia, idiopathic (immune) thrombocytopenia purpura (ITP), or Evans syndrome; 2. Previously failed or contraindicated/intolerant to corticosteroids; 3. Increased bleeding risk indicated by platelet count <30,000/mm3 within previous 28 days.
Thrombotic Thrombocytopenic Purpura (TTP)
Covered when ALL of the following are met
TTP coverage: 1. Immune-mediated or acquired TTP with ADAMTS13-deficiency; AND either (A) used in combination with corticosteroids and therapeutic plasma exchange (TPE) OR (B) used as single-agent prophylactic therapy for patients in remission.
Multiple Sclerosis (relapsing forms)
Covered when ALL of the following are met
MS coverage: 1. Confirmed diagnosis of MS documented by laboratory report (e.g., MRI); 2. Diagnosis of a relapsing form of MS (RRMS, active SPMS, or CIS).
Autoimmune Hemolytic Anemia
Covered when ANY of the following are met
AIHA coverage: 1. Warm-reactive disease refractory to or dependent on glucocorticoids; OR 2. Cold agglutinin disease with symptomatic anemia, transfusion-dependence, and/or disabling circulatory symptoms.
Systemic Lupus Erythematosus (SLE)
Covered when ALL of the following are met
SLE coverage: 1. Confirmed SLE with classification score >10 including clinical and immunologic domains AND ANA titer >1:80 (IIF) or equivalent; 2. Failed to respond adequately to at least two standard therapies; 3. Moderate to severe active disease defined as PGA >1 AND one of: SLEDAI-2K >6 OR >2 systems with BILAG B OR >1 system with BILAG A.
Lupus Nephritis
Covered when ALL of the following are met
Lupus nephritis coverage: 1. Disease non-responsive or refractory to standard first-line therapy (mycophenolate mofetil/mycophenolic acid, cyclophosphamide, or calcineurin inhibitors); 2. Used as single agent OR add-on with mycophenolate mofetil, mycophenolic acid, or cyclophosphamide.
Myasthenia Gravis (MuSK-positive)
Covered when ALL of the following are met
Myasthenia gravis coverage: 1. MuSK-antibody positive disease; 2. Refractory to standard first-line therapy (e.g., glucocorticoids, azathioprine, mycophenolate mofetil).
Complications of Transplanted Solid Organ
Covered when ANY of the following are met
Transplant-related coverage: 1. Used for suppression of panel reactive anti-HLA antibodies prior to transplantation; OR 2. Used for treatment of antibody-mediated rejection of solid organ transplantation. Note: no minimum age requirement for this indication.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Covered when EITHER of the following diagnostic pathways are satisfied and other conditions excluded
NMOSD coverage A: A. Seropositive for AQP4-IgG antibodies AND at least one core clinical characteristic (some require typical MRI findings) AND alternative diagnoses excluded.
NMOSD coverage B: B. Seronegative or unknown AQP4-IgG status AND at least two core clinical characteristics from an attack AND all of: at least one core characteristic must be acute optic neuritis, acute myelitis, or area postrema syndrome; fulfillment of typical MRI findings for each area affected; alternative diagnoses excluded.
NMOSD therapy: Used as single agent or in combination with immunosuppressive therapy (e.g., azathioprine, methotrexate, mycophenolate).
Antisynthetase syndrome ILD coverage: 1. Antisynthetase antibody positive disease; 2. Baseline disease severity assessed with objective measures (glucocorticoid use, PFTs [FVC%, TLC%, DLCO%], or chest CT); 3. Documented severe active disease; 4. Recurrent or progressive disease despite glucocorticoids and/or other immunosuppressives; 5. Will be used in combination with glucocorticoids or other immunosuppressives unless contraindicated.
Idiopathic Membranous Nephropathy
Covered when ANY of the following scenarios apply (with listed conditions)
IMN coverage A: A. First-line therapy in patients with moderate to high risk factors: proteinuria >3.5 g/day with <50% decrease after 6 months ACEi/ARB, OR eGFR <60, OR proteinuria >8 g/day >6 months, OR serious nephrotic complications.
IMN coverage B: B. Used for initial disease relapse after remission on first-line therapy with rituximab, calcineurin inhibitor, or cyclophosphamide + glucocorticoids.
IMN coverage C: C. Used for treatment-resistance to first-line therapy with rituximab, calcineurin inhibitor, or cyclophosphamide + glucocorticoids AND patient has stable eGFR AND will be used with a calcineurin inhibitor if previously treated with rituximab alone in first-line setting.
IMN coverage D: D. Disease recurrence following kidney transplant AND proteinuria >1 g/day.
Pediatric Idiopathic Nephrotic Syndrome
Covered when ALL of the following are met
Pediatric nephrotic syndrome coverage: 1. Patient ≤12 years; 2. Symptomatic disease (nephrotic-range proteinuria with hypoalbuminemia or edema); 3. Diagnosis of FRNS, SDNS, or SRNS per definitions; 4. Failed adequate trial with at least one other steroid-sparing agent (e.g., cyclophosphamide, calcineurin inhibitor, mycophenolate mofetil).
IgG4-Related Disease
Covered when ALL of the following are met
IgG4-RD coverage: 1. Baseline disease severity assessed with objective measure (IgG4-RD Responder Index, PGA, glucocorticoid use, flares, serum IgG4, etc.); 2. Other mimicking conditions ruled out; 3. Documented active disease; 4. Documented failure or ineffective response to adequate trial of glucocorticoids unless contraindicated.
Oncology Indications — continuation
Covered when ALL of the following are met
Oncology continuation: 1. Tumor response with disease stabilization or decrease in tumor size or spread; 2. Patient has not exceeded dosing or duration limits as defined in policy; 3. Absence of unacceptable toxicity (examples listed).
General Renewal Criteria
Renewal covered when ALL of the following are met
General renewal criteria: Continuation of documented current and/or successful therapy with a non-preferred agent (Rituxan or Riabni); AND absence of unacceptable toxicity from the drug.
Examples of unacceptable toxicity are listed in definitions.
Oncology Renewal Criteria
Oncology indications
Oncology renewal: Tumor response with stabilization of disease or decrease in size or spread; AND patient has not exceeded dosing or duration limits as defined elsewhere in the policy.
Applies to listed oncology indications unless specific exceptions noted.
Acute Lymphoblastic Leukemia (ALL)
Adult ALL: Treatment response or stabilization as indicated by CBC, bone marrow cytogenetic analysis, QPCR, or FISH; note that pediatric induction/consolidation may NOT be renewed and Adult ALL renewal limited to maximum 18 doses.
Rheumatoid Arthritis Renewal Criteria
Rheumatoid arthritis
RA renewal: Disease response indicated by improvement in signs and symptoms compared to baseline (e.g., tender/swollen joint counts or improvement on disease activity scoring such as DAS28 ≥1.2 or ACR20 ≥20%); AND dose escalation up to maximum may occur upon clinical review if A) initial response shown, AND B) received at least one maintenance dose at specified interval, AND C) responded to therapy with subsequent loss of response.
Dose escalation is case-by-case clinical review.
ITP/Evans Syndrome Renewal Criteria
Thrombocytopenic purpura (ITP or Evans Syndrome)
ITP renewal: Achievement and maintenance of platelet count ≥ 50 × 10^9/L necessary to reduce bleeding risk.Platelets ≥ 50 × 10^9/L
TTP Renewal Criteria
Thrombotic Thrombocytopenic Purpura (TTP)
TTP renewal: Disease response indicated by an increase in ADAMTS13 activity with a reduction in thrombotic risk.
Multiple Sclerosis Renewal Criteria
Multiple Sclerosis
MS renewal: Continuous monitoring indicates beneficial response; manifestations include relapse rate, new/worsening MRI lesions, and progression of sustained impairment (EDSS, T25-FW, 9-HPT). Inadequate response defined as ≥1 relapse, ≥2 new MRI lesions, or increased disability over one year.
GPA/MPA Renewal Criteria
GPA and MPA
GPA/MPA renewal: Improvement in signs and symptoms compared to baseline; AND decreased frequency of major relapses.
Major relapse defined by reappearance of clinical/lab signs that could lead to organ failure or be life threatening.
Pemphigus Vulgaris Renewal Criteria
Pemphigus vulgaris
Pemphigus renewal: Patient is currently on tapering corticosteroids or has discontinued corticosteroids; AND (A) complete epithelialization of lesions and symptomatic improvement OR (B) no continued development of new lesions/extension/failure to heal OR (for relapses only) prior active disease control AND appearance of ≥3 new lesions/month that do not heal within 1 week or extension of established lesions.
AIHA Renewal Criteria
Autoimmune hemolytic anemia (AIHA)
AIHA renewal: Improvement in anemia signs/symptoms and improvement in laboratory values (Hb/Hct), reduced transfusion needs, and/or reduced glucocorticoid use.
SLE Renewal Criteria
Systemic Lupus Erythematosus (SLE)
SLE renewal: Adequate documentation of disease stability/improvement indicated by one or more: improvement in SELENA-SLEDAI-2K; OR reduction in baseline BILAG-2004 from A to B or B to C/D with no worsening in other systems; OR no worsening (<0.30) in Physician's Global Assessment; OR seroconversion to negative.
Lupus Nephritis Renewal Criteria
Lupus Nephritis
Lupus nephritis renewal: Coverage may only be renewed in patients experiencing a disease relapse (e.g., increased serum creatinine, increased proteinuria, decreased eGFR).
Myasthenia Gravis Renewal Criteria
Myasthenia Gravis (unrelated to immunotherapy-related toxicity)
Myasthenia gravis renewal: Disease response indicated by decrease in daily corticosteroid dose and/or improvement in signs and symptoms compared to baseline.
NMOSD Renewal Criteria
NMOSD
NMOSD renewal: Disease response indicated by stabilization/improvement in: decrease in acute relapses or improved stability; OR reduced hospitalizations; OR reduction/discontinuation in plasma exchange treatments; OR reduction/discontinuation of corticosteroids without relapse.
Complications of Transplanted Solid Organ
Not eligible for renewal
Complications of Transplanted Solid Organ: Coverage may NOT be renewed for complications of transplanted solid organ (kidney, liver, lung, heart, pancreas).
NMOSD
Disease response criteria for continuation/renewal
NMOSD response: Disease response evidenced by stabilization or improvement in at least one of: decrease in acute relapses; reduced hospitalizations; reduction/discontinuation in plasma exchange; reduction/discontinuation of corticosteroids without relapse.
Disease response criteria for Antisynthetase Syndrome-Related ILD
Antisynthetase ILD response: Disease response indicated by: reduction/stabilization of glucocorticoid use from baseline; improvement/stabilization of PFTs (improvement >10% increase in FVC%, TLC%, or DLCO%; stabilization <10% decrease); improvement/stabilization of chest CT score (improvement >10% decrease, stabilization <10% increase).see definitions
Idiopathic Membranous Nephropathy
Idiopathic Membranous Nephropathy coverage logic
Response or resistant disease: Covered if patient experienced beneficial disease response with objective improvement compared to baseline (eg reduction in proteinuria, improved albumin, stable creatinine/eGFR, decreased anti-PLA2R) OR if patient has resistant disease following first-line therapy with rituximab and meets additional requirements (stable eGFR and combination with calcineurin inhibitor if previously treated with rituximab alone).
Pediatric Nephrotic Syndrome: Patient previously achieved beneficial response from prior therapy AND is experiencing recurrent active disease necessitating additional doses as evidenced by either dipstick >3+ (>300 mg/dL) for 3 consecutive days OR UPCR ≥200 mg/mmol (≥2 mg/mg) on spot urine for 3 consecutive days, with or without reappearance of edema.see thresholds
IgG4-RD response and ongoing need: Patient experienced beneficial disease response with improvement in organ-related symptoms/objective measures AND patient either requires ongoing maintenance due to high relapse risk OR is experiencing relapsed active disease necessitating additional therapy.
Examples of objective measures include IgG4-RD Responder Index improvement >2 points, PGA improvement, reduced glucocorticoid use, reduced flares, reduced serum IgG4.
CLL/SLL dosing: 375 mg/m² IV weekly for 8 doses; OR 375 mg/m² IV cycle 1 then 500 mg/m² every 28 days cycles 2-6 (6 total doses).
RA dosing: 1,000 mg on days 1 and 15, repeated every 24 weeks; may repeat up to every 16 weeks if required clinically.
MS/NMOSD dosing: MS: 1,000 mg IV on days 1 and 15, repeat every 6 months. NMOSD: 1,000 mg IV on days 1 and 15, repeat every 6 months OR 375 mg/m² once weekly for 4 weeks, repeat every 6 months.
Pediatric nephrotic dosing: 375 mg/m² IV once weekly for 1-4 doses.
Initial and indication-specific criteria (summary)
Covered when ALL indication-specific criteria are met as detailed in the policy (segment includes additions and revisions to numerous oncology and non-oncology indications).
Indications added or clarified: Multiple oncology and non-oncology indications were added or clarified including Adult Acute Lymphoblastic Leukemia (ALL), Adult Hodgkin lymphoma, various B-cell lymphomas, Hairy Cell Leukemia, Histiocytic Neoplasms (Rosai-Dorfman), Pediatric Hodgkin Lymphoma, Hematopoietic Cell Transplantation indications, Management of Immunotherapy-Related Toxicities, Thrombotic Thrombocytopenic Purpura (TTP), Multiple Sclerosis, Systemic Lupus Erythematosus, Lupus Nephritis, Myasthenia Gravis, Complications of Transplanted Solid Organ, NMOSD, Antisynthetase Syndrome-Related ILD, Idiopathic Membranous Nephropathy, Pediatric Idiopathic Nephrotic Syndrome, IgG4-Related Disease, and others as specified in the policy segment.
See full policy for detailed per-indication criteria and combination therapy requirements.
Renewal criteria
Renewal/continuation criteria vary by indication and are explicitly defined.
Renewal rules: Renewal allowed only when indication-specific response criteria are met; some indications may NOT be renewed (e.g., Pediatric B-cell acute leukemia induction/consolidation, Pediatric Hodgkin Lymphoma, Hematopoietic Cell Transplantation, management of some immunotherapy-related toxicities), while others have dose or duration caps (e.g., Adult ALL max 18 doses).
See per-indication renewal statements for details.
CNS cancer criteria
CNS cancer administration routes and use cases specified.
CNS cancer use: Rituximab may be used for induction as single agent or in combination with methotrexate-containing regimens, temozolomide, or lenalidomide; intrathecal administration permitted for CSF-positive or spinal MRI positive disease; intravenous administration permitted with specific systemic regimens as detailed.
Differentiates intrathecal vs IV use and lists settings for consolidation and relapsed disease.
Selected updated Coverage Criteria
Policy revision entries indicating covered indications and criteria updates (selection of examples reflected in this segment).
CNS/intrathecal use: Used as a single agent OR in combination with systemic therapy in patients with prior whole brain radiation therapy for intrathecal administration when patient has CSF positive or spinal MRI positive disease.
intrathecal-only statement
Intravenous combinations: Used as single agent OR in combination with temozolomide, lenalidomide, or high-dose methotrexate for intravenous administration.
intravenous-only statement
Immunotherapy-related toxicity: Patient has been receiving therapy with an immune checkpoint inhibitor AND either has limited to no improvement after 7 to 14 days on high-dose corticosteroids with or without IVIG, or has specified severe manifestations (e.g., bullous dermatitis, steroid-refractory myositis, myasthenia gravis) requiring rituximab.7-14 days
Certain uses of rituximab have defined limits on renewability and authorization length. Standard authorization is for 6 months (with 12 months initially for pemphigus vulgaris) and may be renewed only when indication-specific renewal criteria are met. Maintenance therapy for oncology indications (excluding ALL) is renewable up to a maximum of 2 years, while Adult ALL renewal is capped at a maximum of 18 doses. Several scenarios are explicitly non-renewable, including induction/consolidation for pediatric B‑cell acute leukemia and aggressive mature B‑cell lymphomas, pediatric Hodgkin lymphoma, chronic graft‑versus‑host disease, and hematopoietic cell transplantation. Management of some immunotherapy‑related toxicities (e.g., myositis, myasthenia gravis, encephalitis) may NOT be renewed, whereas bullous dermatitis is limited to a maximum of 18 months (4 total doses). Renewal for lupus nephritis and pediatric idiopathic nephrotic syndrome is allowed only for documented disease relapse; relapse dosing for pemphigus vulgaris must occur at least 16 weeks after a prior infusion.
Oncology coverage requires that the tumor expresses CD20 (i.e., patient is CD20‑positive) except where the policy explicitly excludes this requirement (chronic GVHD, hematopoietic cell transplantation, and management of immunotherapy‑related toxicity). For non‑oncology indications, coverage is conditional on the member not receiving specified concurrent therapies: the patient must not be on another CD20‑directed therapy, a TNF‑inhibitor, an IL‑inhibitor, a biologic response modifier, or listed non‑biologic agents (examples include apremilast, JAK inhibitors, etc.). Requests that document CD20‑negative disease for oncology indications or that show concurrent excluded therapies risk denial.
For rheumatoid arthritis, initiation under these criteria is excluded if the patient has received rituximab (reference product or biosimilars: Rituxan, Riabni, Ruxience, or Truxima) within the prior 4 months. This prior‑treatment window is required in addition to the RA-specific documentation and prior‑therapy failures described in the RA criteria (e.g., prior oral DMARD and preferred TNF antagonist trials).
Billing Codes, NDCs, and Diagnosis Codes
Prior Authorization, Documentation, and Denial Risks
Prior Authorization
Prior Authorization Required and Biosimilar Step Therapy
Prior authorization (PA) is required for rituximab products. Requests must include clinical evidence that the member meets indication-specific criteria. Coverage decisions for Commercial and Medicaid members follow the plan's biosimilar-first step requirements: Ruxience and Truxima are the preferred agents and a trial/failure of both preferred biosimilars is required for new starts of Rituxan or Riabni unless an exception applies (e.g., indication not FDA‑approved for the biosimilar or supported by NCCN Category 1/2A). Patients must be screened for HBV (HBsAg and anti-HBc) prior to initiating therapy. PA length: standard authorization is up to 6 months (pemphigus vulgaris initial authorization up to 12 months) with specified renewal rules and indication-specific maximums detailed in the dosing/authorization chart.
Commercial & Medicaid preferred agents: Ruxience and Truxima; Non-preferred: Rituxan and Riabni
HBV screening (HBsAg and anti-HBc) required prior to therapy
PA durations: typically 6 months; pemphigus vulgaris initial = 12 months; select oncology/other indications have specific renewal limits
Documentation Required
Initial Therapy Dosing and Requirements
Initial Therapy Dosing Examples
Initial therapy dosing varies by indication; examples provided:
General non-oncology initial: All other non-oncology indications: 100 billable units weekly x4 doses in a 6 month period.
RA: 100 units every 14 days x2 doses in an 18 week period; MS: 100 units every 14 days x2 doses every 6 months.
Pemphigus initiation: Pemphigus vulgaris initiation: 100 billable units weekly x4 doses in a 12 month period; maintenance/relapse dosing per policy (50 billable units every 16 weeks).
CLL initial: CLL/SLL loading: 100 billable units x1 dose, then 130 billable units every 28 days x5 doses per 6 months; renewal therapy: 130 billable units every 8 weeks.
Continuation / Renewal Requirements
Continuation / Renewal
Renewal/maintenance rules vary by indication:
Oncology maintenance renewals: Maintenance therapy for oncology indications (excluding ALL) may be renewed for up to a maximum of 2 years. Adult ALL may be renewed for maximum 18 doses. Mantle cell lymphoma may be renewed until progression or intolerable toxicity. Hairy cell leukemia may be renewed for up to 12 doses. Pediatric induction/consolidation and pediatric Hodgkin may NOT be renewed.
Specific dosing schedules apply per indication.
Autoimmune and other indications: Pemphigus vulgaris: initial 4 weekly doses in 12 months with maintenance/relapse dosing per policy; Lupus nephritis and pediatric idiopathic nephrotic syndrome renewal only in relapse; cGVHD not renewable; hematopoietic cell transplantation not renewable.
See dosing table for exact unit-based schedules.
Renewal Criteria
Renewal/continuation conditions
Step Therapy Requirements and Quantity Limits
Step
Requirement
1
For Commercial and Medicaid members, newly started Rituxan or Riabni requires documented therapeutic failure or intolerance to both plan‑preferred biosimilars (Ruxience AND Truxima) prior to coverage, unless the non‑preferred product is being requested for an indication for which the biosimilars are not FDA‑approved or not supported by NCCN (category 1 or 2A).
Situation
Application
Non‑FDA or non‑NCCN supported indications
If Rituxan or Riabni is requested for an indication for which the plan‑preferred biosimilars (Ruxience or Truxima) are not FDA‑approved or are not supported by NCCN Guidelines/Compendium at category level 1 or 2A, the biosimilar step requirement does not apply and coverage may be considered per indication‑specific criteria (with HBV screening and other general preconditions).
Prior trials required
Details
Oral DMARD trial
For rheumatoid arthritis, patient must have tried and failed at least a 3‑month trial of ONE oral DMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide, etc.), unless already established on biologic therapy.
TNF antagonist trial
Previous failure with one or more preferred TNF antagonists (at least one self‑injectable) is required prior to initiation.
Biosimilar step
For newly started Rituxan or Riabni, failure or intolerance to plan‑preferred biosimilars (Ruxience AND Truxima) is required for Commercial and Medicaid members unless exempt per indication.
Rule
Allowance / Conditions
Dose escalation on review
Dose escalation up to the maximum dose and frequency may be allowed on a case‑by‑case clinical review if the patient initially responded, received at least one maintenance dose at the specified interval, and then demonstrated loss of response; documentation of clinical response required.
Scenario
Requirement
Prior rituximab used first‑line alone
For idiopathic membranous nephropathy previously treated with rituximab alone in the first‑line setting, subsequent rituximab use must be given in combination with a calcineurin inhibitor and patient must have stable eGFR documented.
Indication group
Combination requirement
CLL/SLL and select hematologic malignancies
Rituximab use is specified in combination with particular chemotherapies or targeted agents depending on the indication (examples include combination with fludarabine + cyclophosphamide [FC], bendamustine, or with targeted agents such as TKIs or venetoclax as indicated); combination regimens must follow the indication‑specific criteria.
Population
Enforcement
Commercial and Medicaid new starts
For Commercial and Medicaid members initiating rituximab (Rituxan or Riabni), step therapy requiring documented failure or intolerance to both plan‑preferred biosimilars (Ruxience AND Truxima) must be completed prior to coverage of the non‑preferred products for FDA‑approved indications (step therapy applies to new starts only).
Quantity Limits and Dosing Unit Rules
rituximab (various brands)
Dosing units formatDosing schedules specified in billable units (e.g., 100 or 130 billable units) or mg/m^2 per indication
Example: ALL dosing100 billable units twice weekly x 18 doses
Example: RA dosing100 billable units every 14 days x 2 doses (18-week period)
Example: Immunotherapy toxicity dosing375 mg/m^2 weekly x 4 doses in a 6-month period
rituximab — example quantity limit
Example quantity limit (bullous dermatitis)Maximum of 4 total doses (limited to 18 months)
Context note
Administration Site and Route
Note
Site of care not specified in excerpt
Site of care is not specifically restricted in this excerpt; the policy does not specify a single required setting for administration in the provided segment.
Check local benefit or facility guidance for any site‑of‑care limitations not included in this excerpt.
Note
Infusion center: intravenous administration per dosing schedules
Intravenous administration per the dosing schedules is the standard route for the listed indications; the policy’s dosing tables and indication text reference IV infusion in an infusion setting.
Use documented IV dosing schedules from the policy when submitting authorization and planning infusion services.
Note
Intrathecal vs intravenous administration specified for CNS disease
For CNS disease involving CSF‑positive or spinal MRI‑positive disease, intrathecal administration is specified for intrathecal uses; intravenous administration is specified for systemic and consolidation uses — follow the route specified for the CNS indication.
Biosimilar Preference and Billing
Billing Rule
Preferred biosimilars: Ruxience and Truxima — trial required before non‑preferred
The policy establishes Ruxience and Truxima as the plan‑preferred rituximab biosimilars for Commercial and Medicaid members; coverage for non‑preferred Rituxan or Riabni typically requires trial and failure of the preferred biosimilars.
Preferred biosimilars: Ruxience and Truxima (effective dates and step therapy details in revision history).
Billing Rule
Rituxan/Riabni require failed trials of Ruxience AND Truxima for new starts
Per the policy, newly started Rituxan or Riabni require therapeutic failure or intolerance to both plan‑preferred biosimilars (Ruxience AND Truxima) unless the non‑preferred agent is being requested for an indication not FDA‑approved or not supported by NCCN/Compendium at category 1 or 2A.
Document that Ruxience and Truxima were tried and why each was ineffective or not tolerated when requesting Rituxan or Riabni.
Clinical Background and Definitions
Rituximab is an anti‑CD20 monoclonal antibody used across hematologic malignancies and a range of autoimmune disorders. The policy frames rituximab use by indication‑specific initiation and renewal rules, requires HBV screening (HBsAg and anti‑HBc) prior to starting therapy to mitigate hepatitis B reactivation risk, and distinguishes oncology requirements (notably the CD20‑positive tumor requirement) from non‑oncology rules such as prohibitions on certain concurrent therapies and biosimilar step‑therapy expectations.
CD20-positive
Definition of CD20-positiveExpression of CD20 on target cells; required for oncology indications (except cGVHD, HCT, and immunotherapy-related toxicity)
Oncology applicationApplies to oncology indications to confirm target expression for rituximab use
Exclusion noteNot required for cGVHD, hematopoietic cell transplantation, and management of immunotherapy-related toxicity
CD20-positive (exclusion noted)
Policy Update Log
2024-10-29annual_reviewLatest
Annual review updated length of authorization and dosage chart; added Medicare NCD/LCD statement; clarified general initial preconditions (age ≥18, live-vaccine timing) and oncology CD20 specification.
2023-08-18revision
Updated renewal limits and clarified non-renewable indications; Adult ALL renewal capped at maximum of 18 doses; noted certain pediatric oncology and transplant-related indications may NOT be renewed; adjusted bullous dermatitis renewal cap (18 months/4 doses).
Change TypeMultiple additions, clarifications, and operational updates
Effective Date
Next Review DateOct 29, 2024
Key ActionObtain prior authorization and document HBV screening (HBsAg and anti-HBc) before initiating therapy; trial of preferred biosimilars Ruxience AND Truxima is required for new starts of Rituxan or Riabni unless clinically justified.
Patient is at least 6 months of age; and used in combination with chemotherapy for previously untreated disease.
Adult ALL: For Ph+ disease: used in combination with a TKI-based regimen and patient is <65 years without significant comorbidities OR used with MOpAD for TKI-refractory disease. For Ph- disease: used as a component of multiagent chemotherapy.
CNS lymphoma/leptomeningeal disease: Used for leptomeningeal metastases from lymphomas or primary CNS lymphoma with indication-specific rules for induction, consolidation, or relapsed/refractory disease including intrathecal vs intravenous routes and combination regimen allowances.
Intrathecal for CSF-positive; IV for systemic regimens as specified.
Adult Hodgkin's lymphoma: Patient has nodular lymphocyte-predominant disease.
CLL/SLL: Coverage allowed for specific combinations depending on del(17p)/TP53 status, line of therapy, and concomitant regimens (e.g., FC, bendamustine combinations, idelalisib, lenalidomide, venetoclax, high-dose methylprednisolone, alemtuzumab, OFAR for Richter's transformation).
Adult B-cell Non-Hodgkin lymphomas: Coverage for numerous B-cell lymphomas including AIDS-related, Burkitt (with chemotherapy), DLBCL, follicular/low-grade, EMZL, high-grade B-cell, mantle cell, nodal & splenic marginal zone, PTLD (B-cell), and histologic transformation to DLBCL.
Castleman's disease: Used for multicentric disease OR unicentric disease as second-line for relapsed/refractory disease or unresectable/symptomatic disease after incomplete resection.
Pediatric aggressive mature B-cell lymphomas: Patient at least 6 months of age and used in combination with chemotherapy; may apply to AYA treated in pediatric oncology up to age 39.
Hairy cell leukemia: Use as single agent for relapsed/less than CR in patients unable to receive purine analogs; OR in combination with cladribine or pentostatin in specified scenarios; OR in combination with vemurafenib or venetoclax in defined situations.
Histiocytic neoplasms (Rosai-Dorfman): Used as single agent for nodal, immune-cytopenia, or IgG4-related disease for symptomatic unresectable unifocal or symptomatic multifocal disease or relapsed/refractory disease.
Pediatric Hodgkin lymphoma: Patient ≤18 years (may apply to AYA up to 39 treated in pediatric setting), nodular lymphocyte-predominant disease, used with CVbP, as primary treatment for stage IA or IIA (incomplete resection and non-bulky).
Hematopoietic cell transplantation (HCT): Used as conditioning for allogeneic transplant as part of a non-myeloablative regimen in combination with cyclophosphamide and fludarabine.
Chronic graft-versus-host disease (cGVHD): Post-allogeneic stem cell transplant (generally ≥3 months), used as additional therapy with corticosteroids for steroid-refractory disease after inadequate response/contraindication/intolerance and after at least a 3-month trial of ibrutinib unless inadequate response/contraindication/intolerance.
Management of immunotherapy-related toxicities: Used for immune-checkpoint-inhibitor-related encephalitis (autoimmune-encephalopathy-antibody positive and limited/no improvement after 7–14 days high-dose corticosteroids ± IVIG), bullous dermatitis as additional therapy for G2–G4, steroid-refractory myositis in severe or life-threatening or refractory cases, and myasthenia gravis as additional therapy for severe refractory disease.7-14 days
Non-oncology baseline requirement: Patient is not on concurrent treatment with another CD20-directed therapy, TNF-inhibitor, IL-inhibitor, biologic response modifier or certain specified non-biologic agents.
Rheumatoid arthritis (RA) initial preconditions: Requested by a rheumatologist; adult patient; documented moderate to severe disease; used with methotrexate unless contraindicated; failed at least a 3-month trial of one oral DMARD (unless established on biologic); previous failure with one or more preferred TNF antagonists (at least one self-injectable); baseline objective disease severity assessment documented; no rituximab/biosimilar in prior 4 months.
Pemphigus vulgaris initial preconditions: Adult patient; diagnosis confirmed by clinical features and histopathology and positive DIF or autoantibody testing; moderate to severe disease per objective tool (PDAI, PSS, ABSIS); patient on combination glucocorticoid therapy; other blistering diseases ruled out.
IgG4-RD dosing:
Induction: 375 mg/m² IV once weekly for 1-4 doses OR 1,000 mg IV on days 1 and 15. Subsequent infusions for maintenance/relapse may be administered no sooner than every 6 months.
Updated to add additional checkpoint inhibitors and to revise steroid timing language.
Pemphigus vulgaris: Positive direct immunofluorescence (DIF) microscopy result OR enzyme-linked immunosorbent assay (ELISA) evidence required for diagnosis confirmation.
Indirect immunofluorescence language removed.
Step therapy requirement: For FDA-approved indications, new starts must trial Ruxience AND Truxima prior to Rituxan for Commercial and Medicaid members (effective 07/01/2020); step therapy applies to new starts only.
Medicare members subject to step therapy per policy.
Indication-Specific Prior Authorization and Documentation
Indication-specific prior authorization is required. Providers must submit documentation demonstrating the precise diagnosis, objective measures of disease severity, and prior therapy trials or failures as applicable. For indications with age or specialist restrictions (e.g., RA requests must be from a Rheumatologist; pediatric indications have age limits), include documentation supporting those requirements. Requests lacking the required clinical evidence will not be able to be properly reviewed and may be denied.
Include most specific ICD-10 diagnosis code from the policy's list
Document objective severity using validated tools where requested (e.g., PDAI for pemphigus, DAS28/ACR criteria for RA, PFTs or CT for ILD)
Show prior therapy trials, durations, and reasons for discontinuation (failure or intolerance)
Prior Authorization
Renewal Authorization Requirements
Renewal authorization requires documentation of continued benefit and absence of unacceptable toxicity. Submit objective evidence of response or stabilization using the measures specified for the indication (labs, imaging, disease activity scores, PFTs, etc.). Some indications are explicitly non‑renewable or have capped renewal lengths—verify the dosing/renewal table for limits (e.g., many oncology and transplant-related uses are non‑renewable or have dose/quantity limits).
Renewals must show continuation of documented current/successful therapy with a non-preferred agent when applicable
Absence of unacceptable toxicity must be documented (examples: severe infusion reactions, PML, viral hepatitis, serious infections, cardiac or renal toxicity)
Certain indications are non-renewable (see policy: Pediatric Hodgkin Lymphoma, cGVHD, hematopoietic cell transplantation, some immunotherapy-related toxicities, complications of transplanted solid organ)
Step Therapy
Prior Authorization for Rituximab and Biosimilars
Prior authorization applies to rituximab and its biosimilars with specific dosing schedules and indications requiring PA review. For newly started rituximab (Rituxan or Riabni) in Commercial, Medicaid, and Medicare members, a documented trial and therapeutic failure or intolerance of both preferred biosimilars (Ruxience AND Truxima) is required unless the biosimilars are not FDA‑approved or supported by NCCN for the requested indication.
PA required for listed dosing schedules and all indications in the policy
Biosimilar-first step therapy: trial of Ruxience AND Truxima required for new starts (Commercial & Medicaid); Medicare subject to step therapy where applicable
Exception when biosimilar not FDA-approved or not NCCN-supported for the indication
Documentation Required
Documentation Submission Requirement and Denial Risks
Providers must submit all required clinical evidence and documentation with PA requests. Failure to submit required documentation (diagnosis, objective severity measures, HBV screening, prior therapy trials/failures, and any indication-specific tests such as DIF or ELISA for pemphigus) may result in denial or delay. Use the most specific ICD-10 code available from the policy when submitting a request.
Clinical evidence must demonstrate that member meets all listed criteria for the indication
Missing HBV screening or missing prior trial documentation are common denial triggers
Use the policy's specified ICD-10 diagnoses; claims without an appropriate code from the list may be denied
Documentation Required
Required Documentation for Renewals (Selected Indications)
Provide indication-specific documentation for renewal as detailed below. Renewals must include objective measures showing continued benefit or need and absence of unacceptable toxicity. Examples of acceptable renewal documentation vary by indication—see the list for required evidence per condition.
General: objective response documentation such as CBC, bone marrow, cytogenetics, QPCR, FISH, or imaging for hematologic/oncology indications
RA: documented improvement in tender/swollen joint counts or validated score (e.g., DAS28 improvement ≥1.2 or ACR20 ≥20%); dose escalation may be considered on case review if initial response observed
Pemphigus vulgaris: show complete epithelialization or lack of new/expanding lesions; patient should be tapering or off corticosteroids for maintenance renewals
NMOSD: demonstrate decreased relapses, reduced hospitalizations, reduced plasma exchange use, or decreased corticosteroid requirement without relapse
Antisynthetase Syndrome-Related ILD: improvement/stabilization in PFTs (>10% increase in FVC/TLC/DLCO for improvement; <10% decrease for stabilization), reduction/stabilization of glucocorticoid use, or CT score improvement/stabilization
Idiopathic Membranous Nephropathy: reduction in proteinuria, increased/normalized serum albumin, stable/improved creatinine/eGFR, or decreased anti-PLA2R levels; if previously treated with rituximab alone, maintenance should be combined with a calcineurin inhibitor
Pediatric Idiopathic Nephrotic Syndrome: prior beneficial response to therapy and objective evidence of relapse (e.g., dipstick >3+ for 3 consecutive days or UPCR ≥200 mg/mmol on 3 consecutive days)
IgG4-Related Disease: improvement in IgG4-RD Responder Index (>2 point improvement), PGA, reduction in immunosuppressive use, fewer flares, or decreased serum IgG4; maintenance renewals require high relapse risk or active relapse
Selected IV dosing examples:
Examples: CLL/SLL: 375 mg/m² IV weekly for 8 doses OR 375 mg/m² IV then 500 mg/m² per cycles; MS/NMOSD: 1,000 mg IV days 1 and 15 repeat every 6 months OR 375 mg/m² weekly x4; Pemphigus: 1,000 mg on days 1 and 15 OR 375 mg/m² weekly x4.
See dosing table for full per-indication schedules.
Initial therapy
Initial therapy
Initial therapy prerequisites: HBV screening prior to therapy; step-therapy with Ruxience and Truxima required for newly started Rituxan or Riabni unless indication not supported; age and live vaccine rules apply.
Step therapy applies to new starts only; Medicare members per separate guidance.
Initial therapy requirements
Initial therapy requirements for certain conditions
Initial therapy RA: RA requires prior 3-month oral DMARD trial and prior preferred TNF antagonist failure before initiation (exceptions for patients already established on biologic therapy).
IMN initial: Idiopathic membranous nephropathy: may be used as first-line in patients with specified moderate to high risk factors for progressive disease; other scenarios include relapse, resistance, or post-transplant recurrence with listed conditions.
Initial therapy
Initial dosing regimens vary by indication; examples provided.
CLL/SLL initial: 375 mg/m² IV weekly for 8 doses OR 375 mg/m² IV cycle 1 then 500 mg/m² every 28 days cycles 2-6.
Pemphigus initiation: 1,000 mg IV on days 1 and 15 OR 375 mg/m² IV weekly for 4 doses.
MS initiation: 1,000 mg IV on days 1 and 15, repeat every 6 months.
Initial therapy
Initial criteria for many oncology and non-oncology indications were added or clarified.
Initial criteria summary: Initial authorization requires indication-specific criteria including age limits (e.g., Patient at least 18 years of age unless otherwise specified), absence of recent live vaccine, disease-specific diagnostic confirmation (e.g., CD20-positive for oncology indications unless excluded), and specified combination regimens for certain malignancies.
Full initial criteria are detailed per indication in the main policy.
Initial therapy preference/step therapy
Initial therapy and step therapy rules
Biosimilar-first initial requirement: Effective 07/01/2020, Ruxience and Truxima are preferred agents and a failed trial of both is required prior to using Rituxan for FDA-approved indications for Commercial and Medicaid members.
Step therapy applies to new starts only.
Renewal criteria: 1. Continuation of documented current and/or successful therapy with a non-preferred agent (Rituxan or Riabni); AND 2. Absence of unacceptable toxicity from the drug (examples provided).
Continuation Therapy
Continuation of current therapy requirement
Continuation therapy: Coverage renewal contingent on continuation of documented current and/or successful therapy with a non-preferred agent (Rituxan or Riabni) and absence of unacceptable toxicity
Continuation Therapy
Continuation/renewal supported when documented disease response or relapse criteria are met.
NMOSD continuation: Stabilization/improvement in relapses, hospitalizations, plasma exchange use, or corticosteroid reduction without relapse.
Pediatric Nephrotic continuation: Prior beneficial response AND recurrent active disease per specified urine protein criteria.see thresholds
IgG4-RD continuation: Prior beneficial response AND either high relapse risk requiring maintenance OR relapsed active disease.
Continuation therapy
Continuation/renewal rules are indication-specific.
Continuation requirements: Continuation coverage requires objective evidence of disease response or stabilization per indication (examples include improvement in disease-specific scores, lab markers, imaging, or functional measures). Some indications are excluded from renewal; others have defined maximum doses or may continue until progression.
Refer to per-indication renewal clauses for exact metrics and limits.
Continuation coverage
Continuation of documented current therapy
Continuation of non-preferred agent: Continuation of documented current and/or successful therapy with a non-preferred agent (Rituxan) is included in coverage notes.
Policy allows continuation in some circumstances.
Quantity/duration limits applied in renewal section for immunotherapy-related toxicities and bullous dermatitis
Policy referenceSee Length of Authorization and Revision History for specific caps
Indicate intrathecal versus intravenous administration in the PA based on the clinical scenario (CSF/spinal MRI positive vs systemic disease).
Billing Rule
Billing: include applicable HCPCS/Q-codes and NDCs listed in policy
Biosimilar and reference-product HCPCS and NDC codes are listed in the policy for billing; include the applicable procedure code (e.g., J9312, Q5115, Q5119, Q5123) and NDC when submitting claims or authorization requests.
Provide NDC details as listed in the policy for the product administered.
Note
Note
Billing Rule
Revision: Ruxience/Truxima preferred; failed trials required prior to Rituxan (effective dates in history)
The revision history notes that Ruxience and Truxima were designated preferred and that, effective 07/01/2020, a failed trial of both is required prior to Rituxan for Commercial and Medicaid members; document these trials accordingly.
Revision history documents effective dates and step‑therapy implementation — include trial dates and outcomes in the PA.
Billing Rule
Truxima preferred; indication updates (including pediatric GPA/MPA) reflected in revisions
Truxima’s indications and preferred status were updated in the revision history (including pediatric GPA/MPA updates); check the policy revision notes and include indication‑specific labeling when submitting PAs.
Truxima indications were expanded (e.g., pediatric GPA/MPA ≥2 years) and the product is listed as preferred in the policy history.
Note
CD20-positive exclusion
CD20 positivity not required for certain non-oncology uses (e.g., cGVHD, HCT, immunotherapy-related toxicity)
ImplicationDo not deny non-oncology indications solely for lack of CD20 testing when exclusions apply
Source notePolicy explicitly states the oncology CD20 requirement excludes these settings
HBV screening
Required HBV screening prior to initiationTest HBsAg and anti-HBc prior to starting rituximab
Denial riskFailure to document HBsAg and anti-HBc may trigger denial of authorization
PurposeMitigate hepatitis B reactivation risk with anti-CD20 therapy
NMOSD core clinical characteristics
NMOSD core characteristics — examplesAcute optic neuritis; acute myelitis; acute area postrema syndrome (prolonged hiccups/nausea/vomiting); acute brainstem syndrome (other than APS); symptomatic narcolepsy or acute diencephalic syndrome; acute cerebral syndrome with NMOSD-typical lesion
Use in diagnosisCore characteristics used as part of AQP4-IgG seropositive or seronegative diagnostic pathways
DocumentationTypical MRI findings may be required depending on serostatus and clinical presentation
Typical MRI findings in NMOSD
Typical NMOSD MRI lesion patternsLongitudinally extensive optic nerve or spinal cord lesions; dorsal medulla lesion for area postrema syndrome; periependymal brainstem/diencephalic/cerebral lesions as specified by presentation
ApplicationMRI lesion patterns required for seronegative/unknown AQP4-IgG diagnostic pathway
Diagnostic detailSpecific lesion definitions provided per affected area (optic nerve, spine, brainstem, diencephalon, cerebral)
Unacceptable toxicity
Examples of unacceptable toxicitySevere infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), viral hepatitis, serious infections, cardiac arrhythmias, renal toxicity, bowel obstruction or perforation
Renewal implicationPresence of unacceptable toxicity precludes renewal
Documentation requirementUnacceptable toxicity must be absent for renewal of non-preferred agents
Inadequate response (MS)
Definition of inadequate response (MS)In adherent patients on therapy long enough to realize effect, inadequate response = ≥1 relapse, ≥2 new MRI-detected lesions, or increased disability over one year
Use for renewalDefines failure/continuation decisions for MS indications
Monitoring modalitiesRelapse history, MRI findings, EDSS and functional tests referenced
Improvement/stabilization thresholds for pulmonary function and CT in Antisynthetase Syndrome-Related ILD
Improvement (PFT/CT) threshold>10% change (increase in FVC/TLC/DLCO or decrease in CT score) indicates improvement
Stabilization threshold<10% change (decrease in PFTs or increase in CT score) considered stabilization
ContextUsed to document response for Antisynthetase Syndrome-Related ILD renewals
Follicular lymphoma grade IIIb
Follicular lymphoma grade IIIb codesMultiple ICD-10 entries C82.41–C82.49 specifying grade IIIb by site
Coding implicationSelect the specific ICD-10 code that reflects site and status when submitting requests
ReferenceICD-10 code block listed in policy
Diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma codesICD-10 codes C83.30–C83.39 denote diffuse large B-cell lymphoma with site-specific subcodes
Coding implicationUse appropriate subcode for anatomic site when submitting authorization/claims
SourceICD-10 diagnoses listed in policy
Adult
'Adult' label applicationPolicy updates specify 'Adult' for several lymphoma/leukemia categories where applicable
ImplicationAge requirements emphasized in initial criteria and revisions
ExampleAdult Acute Lymphoblastic Leukemia (ALL) title updated
intrathecal vs intravenous administration
Route distinctionIntrathecal administration specified for CSF-positive or spinal MRI–positive CNS disease; intravenous administration specified for systemic/regimen-based use
ApplicationIntrathecal only for specified CNS indications; IV for others (e.g., temozolomide, lenalidomide combinations)
DocumentationPolicy differentiates route in CNS cancer criteria and dosing tables
revision
Added and clarified multiple new indications and criteria including Hairy Cell Leukemia, Histiocytic Neoplasms (Rosai–Dorfman), Pediatric Hodgkin Lymphoma, Hematopoietic Cell Transplantation, management of immunotherapy-related toxicities, TTP, MS, SLE, lupus nephritis, myasthenia gravis, complications of transplanted solid organ, NMOSD, antisynthetase syndrome–related ILD, idiopathic membranous nephropathy, pediatric idiopathic nephrotic syndrome, and IgG4‑related disease.
2024-03-31revision
Clarified renewal rules and operational limits: removed certain subjective renewal language and specified objective response measures for multiple indications (e.g., ADAMTS13 for TTP; MRI/CBC for ALL; PFT/CT thresholds for antisynthetase ILD).
2024-10-29clarification
Management of immunotherapy-related toxicities wording revised: added cemiplimab and other checkpoint inhibitors and changed steroid-refractory timing to limited/no improvement after 7–14 days of high‑dose corticosteroids ± IVIG.
2024-03-31revision
Pemphigus vulgaris criteria revised to require positive direct immunofluorescence (DIF) microscopy result or ELISA evidence (removed indirect IF language).
2020-07-01policy_change
Established biosimilar-first step therapy: Ruxience and Truxima designated preferred with required trial of both prior to coverage of non-preferred Rituxan for Commercial and Medicaid new starts.
The revision history notes operational updates: the default authorization length is stated as 6 months (with pemphigus vulgaris initially authorized for 12 months) and the dosing/authorization table was updated. Several indications and renewal rules were added or clarified in the latest review, and the document explicitly records those changes to renewability and maximum dosing limits (for example, Adult ALL maximum of 18 doses and oncology maintenance renewal limits).