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Coverage criteria policies

Rituximab (Rituxan®, Rituxan Hycela®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Coverage for rheumatoid arthritis and most off-label uses requires prior authorization from Pharmacy Administration.

Rituxan: Prior authorization is not needed for FDA-approved oncology uses, autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.

Rituxan Hycela: Prior authorization is not needed for FDA-approved oncology uses.

Coverage

Rituxan Hycela is generally covered without prior authorization when the criteria listed below are met:

  1. For Hematology/Oncology, Rituxan is generally covered when prescribed by an hematologist/oncologist for use in:
    1. Follicular Lymphoma
    2. Diffuse Large B-cell Lymphoma (DLBCL)
    3. Chronic Lymphocytic Leukemia (CLL)

Rituxan is generally covered when the criteria listed below are met:

  1. For Hematology/Oncology, Rituxan is generally covered when prescribed by an hematologist/oncologist for use in:
    1. Non-Hodgkin’s Lymphoma; or
    2. Chronic Lymphocytic Leukemia; or
    3. Autoimmune Hemolytic Anemia, or
    4. Idiopathic Thrombocytopenic Purpura
  2. Rituxan is generally covered when prescribed for the treatment of adults with Wegener Granulomatosis (granulmatosis with polyangiitis) or Microscopic Polyangiitis when prescribed by a Rheumatologist or Nephrologist and when used in combination with glucocorticoids.
  3. For Rheumatoid Arthritis, Rituxan is generally approved for use in adult patients diagnosed with moderate to severe rheumatoid arthritis when all the following criteria are met:
    Initial approvals
    1. Prescribed and followed by Rheumatology.
    2. Patient has had a trial and failure of an appropriate regimen of DMARD therapy including concurrent use of two or three of the regimens below for at least 3 months or intolerance or a contraindication to use:
      1. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
      2. Hydroxychloroquine titrated to 200-400mg daily
      3. Sulfasalazine titrated to 2000mg-3000mg daily
      4. Leflunomide 10-20mg daily
    3. Patient has had a trial and failure to two preferred biologic therapies (e.g., Enbrel, Humira or Remicade) for at least 3 months or intolerance or a contraindication to use.
    4. The prescribed regimen is within the FDA-approved dosing regimen of two-1000mg infusions separated by 2 weeks every 24 weeks. (Requests for cycles 16 - 23 weeks apart will require demonstrated failure with 24 week cycle intervals.)
    5. No other biologic agent will be used concurrently to treat this indication.

Authorizations will be provided for one year with a maximum of 4 infusions. No more than 1000mg may be billed per infusion.

Reauthorizations for biologic regimens of up to FDA-approved doses and frequencies

Renewals will be provided annually with provider attestation that they have seen the patient within the last fourteen months and the patient is benefiting from use of the medication.

Requests for more intense (dose or interval) biologic therapy than the FDA-approved regimen

All requests for regimens exceeding the FDA-approved regimen (including annual renewals) will require provider attestation that the off-label regimen is medically necessary.

All other uses will be reviewed on a case-by-case basis for evidence of efficacy and for medical necessity.

Definitions

Rituximab (Rituxan) is an infused CD20-directed cytolytic antibody indicated for the treatment of patients with:

  • Non-Hodgkin’s Lymphoma
  • Chronic Lymphocytic Leukemia
  • Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies.
  • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

Limitations of Use: Rituxan is not recommended for use in patients with severe, active infections.

Rituximab (Rituxan Hycela) is a subcutaneous CD20-directed cytolytic antibody indicated for the treatment of patients with:

  • Follicular Lymphoma
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Chronic Lymphocytic Leukemia (CLL)

Limitations of Use:

  • Rituxan Hycela must be initiated only after patients have received at least one full dose of a rituximab product by intravenous infusion.
  • Rituxan Hycela is not indicated for the treatment of non-malignant conditions
  • Rituxan Hycela is not recommended for use in patients with severe, active infections.

Rituximab is a monoclonal antibody directed against the CD20 antigen found on B lymphocytes.  Administration of Rituximab results in a rapid and sustained depletion of B cells.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Code

    Code

    Description

    J9310

    Injection, rituximab, 100 mg

    J9999

    Not otherwise classified, antineoplastic drugs

NDC Codes

    Codes

    Description

    50242005121

    Rituxan 100 mg/10 mL single-use vial

    50242005306

    Rituxan 500 mg/50 mL single-use vial

    50242010901

    Rituxan Hycela 1600-26800 mg – UT/13.4 ML SOLN

    50242010801

    Rituxan Hycela 1400-23400 mg – UT/11.7 ML SOLN

ICD-10-CM Codes

For Rituxan and Rituxan Hycela: Prior authorization is not required for the following diagnosis codes.

Codes

Description

C81.00-C81.99

Hodgkin lymphoma

C82.00-C82.99

Follicular lymphoma

C83.00-C83.09

Small cell B-cell lymphoma

C83.10-C83.19

Mantle cell lymphoma

C83.30-C83.39

Diffuse large B-cell lymphoma

C83.50-C83.59

Lymphoblastic (diffuse) lymphoma

C83.70-C83.79

Burkitt lymphoma

C83.80-C83.99

Non-follicular lymphoma

C84.60-C84.79

Anaplastic large cell lymphoma

C84.A0-C84.A9

CutaneousT-cell lymphoma

C84.Z0-C84.Z9

Other mature T/NK-cell lymphomas

C84.90-C84.99

Mature T/NK-cell lymphomas

C85.10-C85.29

B-cell lymphoma

C85.80-C85.99

Non-Hodgkin lymphoma

C86.0

Extranodal NK/T-cell lymphoma, nasal type

C86.1

Hepatosplenic T-cell lymphoma

C86.2

Enteropathy-type (intestinal) T-cell lymphoma

C86.3

Subcutaneous panniculitis-like T-cell lymphoma

C86.4

Blastic NK-cell lymphoma

C86.5

Angioimmunoblastic T-cell lymphoma

C86.6

Primary cutaneous CD30-positive T-cell proliferations

C88.4

Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALTlymphoma]

C88.8

Other malignant immunoproliferative diseases

C91.00-C91.02

Acute lymphoblastic leukemia

C91.10-C91.12

Chronic lymphocytic leukemia of B-cell type

C91.40-C91.42

Hairy cell leukemia

C94.40-C94.42

Acute panmyelosis with myelofibrosis

C94.6

Myelodysplastic disease, not classified

C96.4

Sarcoma of dendritic cells (accessory cells)

C96.Z

Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue

C96.9

Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

D47.1

Chronic myeloproliferative disease

D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

D47.9

Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified

    K31.7

    Polyp of stomach and duodenum

    K63.5

    Polyp of colon

    Q85.00-Q85.09

    Neurofibromatosis

    Z51.0

    Encounter for antineoplastic radiation therapy

    Z51.11

    Encounter for antineoplastic chemotherapy

    Z51.12

    Encounter for antineoplastic immunotherapy

For Rituxan: Prior authorization is not required for the following diagnosis codes. Prior authorization is required for Rituxan Hycela.

    Codes

    Description

    D59.0

    Drug-induced autoimmune hemolytic anemia

    D59.1

    Other autoimmune hemolytic anemias

    D68.32

    Hemorrhagic disorder due to extrinsic circulating anticoagulants

    D68.4

    Acquired coagulation factor deficiency

    D69.41

    Evans syndrome

    D69.42

    Congenital and hereditary thrombocytopenia purpura

    D69.49

    Other primary thrombocytopenia

    D69.3

    Immune thrombocytopenic purpura

    M30.0

    Polyarteritis nodosa

    M30.1

    Polyarteritis with lung involvement [Churg-Strauss]

    M30.2

    Juvenile polyarteritis

    M30.3

    Mucocutaneous lymph node syndrome [Kawasaki]

    M30.8

    Other conditions related to polyarteritis nodosa

    M31.0

    Hypersensitivity angiitis

    M31.1

    Thrombotic microangiopathy

    M31.2

    Lethal midline granuloma

    M31.30-M31.31

    Wegener's granulomatosis with or without renal involvement

    M31.4

    Aortic arch syndrome [Takayasu]

    M31.5

    Giant cell arteritis with polymyalgia rheumatic

    M31.6

    Other giant cell arteritis

    M31.7

    Microscopic polyangiitis

    D59.0

    Drug-induced autoimmune hemolytic anemia

    D59.1

    Other autoimmune hemolytic anemias

    C88.0

    Waldenstrom macroglobulinemia

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Prior authorization is required for all other diagnosis codes.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Rituxan Prescribing Information. Genentech, Inc: South San Francisco, CA. April 2016.
  2. Smolen JS, Landewe R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-975.
  3. Singh JA, Furst DE, Bharat A, et al., 2012 Update of the 2008 ACR Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Research 2012:64(5):625-639.

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Policy activity

  • 01/24/2006 - Date of origin
  • 09/01/2017 - Effective date
Review date
  • 08/2017
Revision date
  • 08/14/2017

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