Rituximab (Rituxan)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • ANCA-associated vasculitis
  • Autoimmune Hemolytic Anemia (AIHA)
  • Chronic Lymphocytic Leukemia (CLL)
  • CNS Lymphoma
  • Immune Thrombocytopenic Purpura (ITP)
  • Non-Hodgkin's Lymphoma
  • Rheumatoid Arthritis (moderate to severe)
  • Waldenstrom's Macroglobulinemia
  • Devic's Disease

Patient's must meet the following criteria for the indications above:

ANCA-associated vasculitis

  • Diagnosis of ANCA-associated vasculitis, microscopic polyangitis, or Wegener’s granulomatosis AND
  • Intolerance, contraindication, or inadequate response to cyclophosphamide

Autoimmune Hemolytic Anemia (AIHA)

  • Diagnosis of autoimmune hemolytic anemia (including AIHA following allogeneic bone marrow transplantation)

Chronic Lymphocytic Leukemia (CLL)

  • Diagnosis of CLL

CNS lymphoma

  • Diagnosis is primary CNS lymphoma
  • Used as first-line treatment in combination with methotrexate
  • Used for recurrent or progressive disease following prior systemic anticancer therapy or radiation therapy

Immune Thrombocytopenic Purpura (ITP)

  • Patient has chronic, refractory ITP AND
  • Platelet count <30, 000/mcl (i.e. <30 x10-9/L) AND
  • Either of the following:
    • Inadequate response, intolerance, or contraindication to two of the following treatments: corticosteroids, IVIG, anti-D antibody, or splenectomy OR
    • Inadequate response, intolerance, or contraindication to Promacta or Nplate after meeting step therapy requirements for either drug

Non-Hodgkin’s Lymphoma

  • Rituxan will be approved based on ONE of the following criteria:
    • Confirmed diagnosis of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin’s lymphoma
    • First-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens
    • First-line treatment of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine, prednisolone/prednisone) chemotherapy
    • Treatment of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/prednisone) chemotherapy
    • Confirmed diagnosis of relapsed or refractory, low grade or follicular CD20-positive, B-cell non-Hodgkin's lymphoma
    • Confirmed diagnosis of chronic lymphocytic leukemia (off-label/evidence-based)
    • Immune or idiopathic thrombocytopenic purpura (off-label/evidence-based)
    • Confirmed diagnosis of Waldenstrom's macroglobulinemia (off-label/evidence-based)

Rheumatoid Arthritis (moderate to severe)

  • Treatment in combination with methotrexate to reduce signs and symptoms in adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies
  • Patient Age > 18 years, AND
  • Moderately- to severely-active rheumatoid arthritis (RA) defined by all of the following:
    • At least 6 swollen joints AND
    • At least 6 tender/painful joints, AND
    • One of the following:
      • More than 45 minutes of morning stiffness
      • Elevated erythrocyte sedimentation rate (ESR) unless the patient is receiving corticosteroids
      • Elevated C-reactive protein (CRP) unless patient is receiving corticosteroids, AND;
      • Used in combination with methotrexate, AND
      • Documented treatment failure (inadequate response) to a TNF antagonist (adalimumab [Humira], etanercept [Enbrel], or infliximab [Remicade]), AND
      • Diagnosed by a rheumatologist

Waldenstrom's Macroglobulinemia

  • Diagnosis of Waldenstrom’s macroglobulinemia, macroglobulinemia, or macroglobulinemia (idiopathic) primary

Acute Lymphoblastic Leukemia, Philadelphia chromosome-negative (Ph-)

  • Diagnosis of Philadelphia chromosome-negative ALL
  • Patient age greater than or equal to 40 years AND
  • Given as part of a regimen including HyperCVAD* therapy alternating with high dose methotrexate and cytarabine with Rituxan
  • *cyclophosphamide, vincristine, doxorubicin, and dexamethasone

Divic's Disease

  • Confirmed diagnosis of Devic's Disease

Reauthorization Criteria

  • At least 20% improvement in the tender and swollen joint count; AND
  • At least 20% improvement in three of the following:
    • Patient’s global assessment
    • Physician’s global assessment
    • Patient’s assessment of pain
    • Degree of disability
    • Acute-phase reactant (ESR or CRP)
    • Submission of chart documentation demonstrating the clinical equivalent of the above criteria; AND
    • At least 16 weeks have elapsed since last course of therapy
  • Reauthorization will be issued for one additional course of therapy per approval

Dosing:

ANCA-associated vasculitis

  • Up to 375 mg/m2 IV infusion once weekly for 4 doses

Autoimmune Hemolytic Anemia (AIHA)

  • Up to 375 mg/m2 weekly up to 4 weeks

Chronic Lymphocytic Leukemia (CLL)

  • Up to 500 mg/m2 IV infusion once weekly for up to 8 doses

CNS lymphoma

  • Up to 375 mg/m2 as often as every 21 days OR
  • Up to 750 mg/m2 weekly for up to 8 doses

Immune Thrombocytopenic Purpura (ITP)

  • Up to 375 mg/m2 weekly up to 4 weeks

Non-Hodgkin’s Lymphoma:

  • Initial or Retreatment of active disease: 375 mg/m2 IV infusion once weekly for up to eight doses per treatment course
  • Maintenance therapy: For patients in remission, cover 375 mg/m2 per dose for 16 doses divided over 2 years

Diffuse Large B-Cell NHL:

  • 375 mg/m2 IV per infusion given on day one of each cycle of chemotherapy for up to eight (8) infusions

Rheumatoid Arthritis:

  • Two 1000 mg IV infusions separated by two weeks, which is considered one course. Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions
  • Treatment courses must be separated by a minimum of 16 weeks
  • Safety and efficacy of retreatment have not been established in controlled trials
  • Rituxan is given in combination with methotrexate

Waldenstrom's Macroglobulinemia

  • Initial: up to 375 mg/m2 IV infusion once weekly for up to 8 doses
  • Maintenance: Maximum of 375mg/m2 IV infusion every 3 months

Acute Lymphoblastic Leukemia, Philadelphia chromosome-negative (Ph-)

  • Initial:  Up to 375 mg/m2 IV infusion for up to 8 doses per treatment course
  • Maintenance:  Up to 375 mg/m2 IV infusion for up to 4 doses over 12 months

Devic's Disease

  • Initial:  375 mg/m2/wk for 4 weeks or 1000 mg infused twice, with 2 weeks between doses
  • Repeat every 6 to 12 months

Approval:

  • Authorization will be issued for one course of therapy

 

Last review date: July 21, 2016

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