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

Approval Period:

Authorization will be issued for one course of therapy.

Reauthorization Criteria

Rituxan will be approved for continuation of RA therapy based on both of the following criteria:

  1. At least 20% improvement in the tender and swollen joint count; AND
  2. 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


Western Health Advantage Pharmacy and Therapeutics Committee

Approved:  September 2014 

Last review date: July 21, 2016