RXMP-15 Rituximab Form

Rituximab

Updated on: 10/20/2025

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Policy Number RXMP-15 Line of Business Medicaid & Medicare Effective Date 10/11/2019 Revision Date 10/20/2025

Products: Rituximab, Riabni, Ruxience, Truxima

Override(s)
Approval Duration
Prior Authorization
Initial: 3 months; Reauthorization 12 months

HCPCS Code Description Quantity Limit
Medical Benefits: Authorization Required; Excluded on the Pharmacy Benefits J9312 Injection, rituximab, 10 mg [Rituxan] See dosing information Q5115 Injection, rituximab-abbs, biosimilar, (truxima), 10 mg Q5119 Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg (preferred) Q5123 Injection, rituximab-arrx, biosimilar, (riabni), 10 mg (preferred)

Medicare Criteria Medicare Part B Coverage Criteria
• Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • LCD as of 10/20/2025: LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (L39396) (cms.gov) • Note: Effective 4/1/2026, all chemotherapy indications will be reviewed by Optum Health. • For new starts, step therapy criteria must be met in addition to clinical criteria before a request may be approved. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• Rituxan and Trixima (new starts): The member has an inadequate response to, intolerable adverse event to, or has a contraindication to Ruxience and Riabni. Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage.

Note: Pharmacy staff: For QUEST & Medicare FIDE members, refer to ADRC referral with chart notes.

Approval Criteria

Products Congenital Alpha-1 Antitrypsin (AAT) Deficiency and Emphysema Approval Length Initial 6 months Override Type PA
PA CRITERIA FOR APPROVAL FOR MEDICARE/MEDICAID:

1. Diagnosis of Rheumatoid Arthritis (For Rituxan) AND a. The medication is prescribed or recommended by a Rheumatologist AND 1) Request is for New Therapy AND

Rituximab

Updated on: 10/20/2025

Page 2 of 4 2) The member has a documented inadequate trial (minimum of 3 months therapy) of methotrexate (MTX) as indicated by increased in tender/swollen joint count, pain, or other measures such as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) levels AND 3) Rituximab is being used concurrently with methotrexate, unless MTX is contraindicated
AND 4) For Medicaid: Rituxan, Trixima: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Ruxience and Riabni. OR 5) Request is for continuation for therapy; AND 6) Documentation has been provided showing the member has clinical benefit from receiving Rituximab therapy AND 7) At least 16 weeks (or 4 months) has elapsed since the previous course of Rituximab therapy; AND 8) Rituximab is being used concurrently with methotrexate, unless MTX is contraindicated
AND 9) For Medicaid: Rituxan, Trixima: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Ruxience and Riabni. OR

2. Diagnosis of Non-Hodgkin’s Lymphoma (NHL) or Chronic lymphocytic leukemia (CLL) (C85-C85.99 and C91.1 including lymphosarcoma and reticulosarcoma and other specified malignant tumors, nodular lymphoma, Non- Hodgkin’s type NEC, or chronic lymphoid/lymphocytic leukemia) (For rituximab is approved for this indication); AND a. Continuation of therapy with previous approved prior authorization on file or claims history; OR b. The medication is prescribed or recommended by an Oncologist or Hematologist/Oncologist AND c. For Medicaid: Rituxan, Trixima: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Ruxience and Riabni. OR
3. Diagnosis of Granulomatosis with polyangiitiis (GPA), Wegener’s Granulomatosis, or Microscopic Polyangiitis (MPA) (For Ruxience or Rituxan) AND a. Continuation of therapy with previous approved prior authorization on file or claims history; OR b. The medication is prescribed or recommended by a Hematologist, Pulmonologist, Otolaryngologist (or ENT specialist), Nephrologist, Or Rheumatologist or a specialist in the field of treating the condition; AND c. Rituxan is being used concurrently with glucocorticoids (such as prednisone); AND d. For Medicaid: Rituxan, Trixima: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Ruxience and Riabni. OR

4. Diagnosis of Idiopathic thrombocytopenic purpura (ITP) (For Rituxan); AND a. The medication is prescribed or recommended by a Hematologist or Hematologist/Oncologist; AND b. Member is at risk of spontaneous bleeding as demonstrated in chart notes by either one of the following criteria: 1) Platelet count is <20,000/mm3; OR 2) Platelet count is <30,000/mm3 accompanied by symptoms of bleeding
   AND c. Previously failed first-line therapy with corticosteroid (e.g. prednisone 1 to 2 mg/kg for 2 to 4 weeks, or pulse dexamethasone 40 mg daily for 4 days) has been ineffective, unless contraindicated or not tolerated.
   AND d. For Medicaid: Rituxan, Trixima: The member has an inadequate response to, intolerable adverse event to, or has a contraindication for Ruxience and Riabni.

   Exclusion EXCLUSION:
   Rituxan is not recommended for use in patients with severe, active infections.

Rituximab

Updated on: 10/20/2025

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INVESTIGATIONAL USES
Rituximab (Rituxan) has been studied in several non-oncologic/non-hematologic conditions including chronic graft versus host disease, MS, and systemic lupus erythematosus (SLE). ▪ Current studies of rituximab (Rituxan) in chronic graft versus host disease are small and preliminary. Larger well- controlled trials are needed to establish the safety and efficacy of rituximab in this population.
▪ A large phase III randomized controlled trial that studied rituximab (Rituximab) in the treatment of MS did not meet is primary endpoint. Additional studies are necessary to demonstrate safety and efficacy in patients with MS.
▪ A large phase III randomized controlled trial that studied rituximab (Rituxan) versus placebo in patients with SLE did not meet its primary endpoint. Additional studies are necessary to demonstrate safety and efficacy in patients with SLE.

FDA Indications & Dosing Drug Name Indication Dosing/Administration Rituxan Ruxience Truxima Riabni Non-Hodgkin’s Lymphoma (NHL) 375mg/m2 IV infusion day 1 of each chemotherapy cycle for up to 8 cycles Rituxan Ruxience Truxima Riabni Chronic Lymphocytic Leukemia (CLL)
375mg/m2 in the first cycle and 500mg/m2 in cycles 2-6 in combination with FC, administered every 28 days Rituxan Rheumatoid Arthritis (RA) in combination with methotrexate in adults with moderately- to severely- active RA who have inadequate response to one or more TNF antagonist therapies Two (2) 1,000mg IV infusion separated by 2 weeks (one course) every 24 weeks or based on clinical evaluations but not sooner than every 16 weeks.
Rituxan Ruxience Riabni Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microsocopic Polyangiitis (MPA) in adult patients in combination with glucocoticoids 375mg/m2 once weekly for 4 weeks. Rituxan Pemphigus Vulgaris (PV) 1000mg IV Week 1 & 3, 500mg IV Month 12, then 500mg IV Q6Months
Rituxan Off-Label: Idiopathic thrombocytopenic purpura (ITP)
375mg/m2 IV once weekly for 4 doses

Indication(s) Usual Dosing Rituxan Truxima Ruxience Riabni Non-Hodgkin's Lymphoma (NHL) 375 mg/m2 IV various dosing regimens, depending on disease status X X X X Chronic Lymphocytic Leukemia (CLL) 375 mg/m2 (Cycle 1), then 500 mg/m2 (Cycles 2-6) IV Q28 days, in combination with fludarabine and cyclophosphamide X X X X Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) Induction: 375 mg/m2 IV QWeek x4 weeks Maintenance: 500mg IV Week 1 & 3, then 500mg IV Q6Months X

X X Rheumatoid Arthritis (RA) 1000mg IV Week 1 & 3 Q16-24Weeks, in combination with methotrexate X

Pemphigus Vulgaris (PV) 1000mg IV Week 1 & 3, 500mg IV Month 12, then 500mg IV Q6Months
X

Rituximab

Updated on: 10/20/2025

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REFERENCES:

1. eFacts and Comparisons
2. ReimbursmentCodes.com
3. Rituxan Package Insert. Genentech, Inc.

4. DrugDex

   Change History 5/22/2023 HB: New (adopted from OptumRx Prior Authorization Guideline)
   4/2/2025 AP: Added Medicare Continuity of Care requirement 10/20/2025: Move to new template