Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-38-017
Topic: Rituximab (Rituxan) and Rituximab and Hyaluronidase Human (Rituxan Hycela)
Section: Injections
Effective Date: July 30, 2018
Issue Date: July 30, 2018
Last Reviewed: April 2018

Rituximab (Rituxan®) is a genetically engineered chimeric murine/human monoclonal antibody. It binds specifically to the antigen CD20 (human B-lymphocyte-restricted differentiation antigen, Bp35). This antigen is a hydrophobic transmembrane protein that is located on pre-B and mature B lymphocytes. It is also expressed on more than 90% of B-cell non-Hodgkin's lymphomas, but it is not expressed on hematopoietic stem cells, pro-B cells, normal plasma cells, or other normal tissues.

Rituximab and hyaluronidase human (Rituxan Hycela™) is a combination of rituximab and hyaluronidase human in a subcutaneous formulation that is given by a healthcare professional after an initial administration of intravenous rituximab (Rituxan). These two products are different formulations and cannot be used interchangeably.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Rituximab (Rituxan) Intravenous (IV)

FDA Approved Indications

Rituximab (Rituxan) may be considered medically necessary for ANY of the following indications:

Rheumatoid Arthritis (RA)

Rituximab for the treatment of adults with RA may be considered medically necessary for the following conditions:

Antineutrophil Cytoplasmic Antibody‒Associated Vasculitides (Granulomatosis with Polyangiitis [Wegener Granulomatosis] and Microscopic Polyangiitis)

Rituximab (Rituxan), in combination with glucocorticoids, may be considered medically necessary for the treatment of individuals with antineutrophil cytoplasmic antibody‒associated vasculitides (i.e., granulomatosis with polyangiitis (GPA) [Wegener granulomatosis] and microscopic polyangiitis).

Non-Hodgkin’s Lymphoma (NHL)

Rituximab (Rituxan) may be considered medically necessary for the treatment of NHL.

Chronic Lymphocytic Leukemia (CLL)

Rituximab (Rituxan) may be considered medically necessary for the treatment of CLL.

The use of rituximab for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes
J9310


Other clinically supported indications

Rituximab (Rituxan) may be considered medically necessary for the following off-label indications:

 

Autoimmune Hemolytic Anemia (AIHA)

Rituximab (Rituxan) may be considered medically necessary for the treatment of EITHER of the following AIHA:

 

Thrombotic Thrombocytopenic Purpura

Rituximab (Rituxan) may be considered medically necessary for the treatment of thrombotic thrombocytopenic purpura in individuals with refractory disease or relapse (i.e., lack of response to plasma exchange therapy and glucocorticoids).

 

Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis)

Rituximab (Rituxan) may be considered medically necessary as treatment for Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis):

 

Hemophilia

Rituximab (Rituxan) may be considered medically necessary for the treatment of hemophilia with acquired inhibitors who are refractory to conventional first line treatments (i.e. immunosuppression with prednisone and cyclophosphamide).

 

Hepatitis C Virus‒Associated Cryoglobulinemic Vasculitis

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for individuals with hepatitis C virus‒associated cryoglobulinemic vasculitis who have:

 

Multicentric Castleman Disease Associated with Human Herpesvirus 8 (HHV-8) in HIV-Infected Individuals

Rituximab (Rituxan) may be considered medically necessary as treatment for multicentric Castleman disease (first- or second-line therapy).

 

Neuromyelitis Optica

Rituximab (Rituxan) may be considered medically necessary as treatment for neuromyelitis optica for relapse prevention.

 

Pemphigoid Diseases

Rituximab (Rituxan) may be considered medically necessary as treatment for ANY of the following pemphigoid diseases in treatment-refractory individuals:

 

Pemphigus Diseases

Rituximab (Rituxan) may be considered medically necessary as treatment for pemphigus diseases (i.e., pemphigus vulgaris, pemphigus foliaceus, and paraneoplastic pemphigus).

 

Primary Sjögren Syndrome

Rituximab (Rituxan) may be considered medically necessary as treatment for primary Sjögren syndrome that is refractory to glucocorticoids and at least two other immunosuppressive agents (e.g. cyclosporine, methotrexate, azathioprine, corticosteroids, etc.).

 

Systemic Lupus Erythematosus

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for systemic lupus erythematosus refractory to standard first-line treatment.

 

Lupus Nephritis

Rituximab (Rituxan) may be considered medically necessary as add-on therapy for lupus nephritis refractory to standard first-line treatment regimen.

 

Systemic Sclerosis (Scleroderma)

Rituximab (Rituxan) may be considered medically necessary as treatment for systemic sclerosis (scleroderma) in individuals refractory to first-line treatment.

 

Glucocorticoid-Refractory Chronic Graft-Versus-Host Disease

Rituximab (Rituxan) may be considered medically necessary as treatment for glucocorticoid-refractory chronic graft-versus-host disease.

 

Desensitization of Human Leukocyte Antigen‒Sensitized Renal Transplant Candidates

Rituximab (Rituxan) may be considered medically necessary for desensitization of human leukocyte antigen‒sensitized renal transplant candidates before transplantation.

 

Idiopathic Membranous Nephropathy

Rituximab (Rituxan) may be considered medically necessary as treatment for idiopathic membranous nephropathy.

 

Epstein-Barr virus disease; Prophylaxis - Hemopoietic stem cell transplant

Rituximab (Rituxan) may be considered medically necessary for the prevention of Epstein Barr virus infection in hematopoietic stem cell transplant individuals.

 

Evans syndrome (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for Evans syndrome refractory to immunosuppressive therapy.

 

Idiopathic Thrombocytopenic purpura (Adult only)

Rituximab (Rituxan) may be considered medically necessary as treatment for idiopathic thrombocytopenic purpura.

 

Immune thrombocytopenia, previously treated (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for previously treated immune thrombocytopenia.

 

Microscopic polyarteritis nodosa (Adult only)

Rituximab (Rituxan) may be considered medically necessary as treatment for microscopic polyarteritis nodosa in combination with glucocorticoids.

 

Minimal change disease (Pediatric only)

Rituximab (Rituxan) may be considered medically necessary as treatment for refractory, steroid-dependent or steroid-resistant minimal change disease when:

 

Relapsing-Remitting Multiple Sclerosis

Rituximab (Rituxan) may be considered medically necessary as treatment for relapsing-remitting multiple sclerosis when:

 

Myasthenia Gravis

Rituximab (Rituxan) may be considered medically necessary as treatment for relapsed or refractory myasthenia gravis in individuals who have failed to respond to, or are intolerant to, conventional therapy, including azathioprine.

 

Idiopathic Inflammatory Myopathy

Rituximab (Rituxan) may be considered medically necessary as treatment for refractory idiopathic inflammatory myopathy in individuals who have failed to respond to, or are intolerant to, another immunosuppressant (e.g. methotrexate).

 

The use of rituximab for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes
J9310


NCCN Approved Indications

Rituximab (Rituxan) may be considered medically necessary for ANY of the following indications:

Central nervous system cancers

 

 

Hodgkin Lymphoma

 

Non-Hodgkin Lymphomas

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The use of rituximab (Rituxan) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes
J9310


Rituximab and hyaluronidase human (Rituxan Hycela) subcutaneous (SC) – healthcare administered

FDA Approved Indications

Rituximab and hyaluronidase human (Rituxan Hycela) may be considered medically necessary for ANY of the following indications:

The use of rituximab and hyaluronidase human (Rituxan Hycela) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications

Procedure Codes
J3590


NCCN Approved Indications

Rituximab and hyaluronidase human (Rituxan Hycela) may be considered medically necessary for ANY of the following indications:

The use of rituximab and hyaluronidase human (Rituxan Hycela) for all other indications not listed on this policy is considered experimental/investigational and therefore, not covered. Scientific evidence does not support the use for all other indications.

Procedure Codes
J3590


*Maintenance rituximab is not appropriate after bendamustine and rituximab therapy and has not been tested after VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) or RBAC (rituximab, bendamustine and cytarabine) therapy.

**Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines

NOTE: Dosage recommendations per the FDA label. 

Refer to medical policy I-25 Desensitization Treatment for Heart and Renal Transplant for additional information.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Rituximab (Rituxan®) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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