Intravenous Rituximab
Intravenous rituximab (Rituxan) may be considered medically necessary to treat patients with non-Hodgkin lymphoma (NHL) for the following U.S. Food and Drug Administration (FDA) labeled indications:
Follicular lymphoma (FL):
Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy
Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
Diffuse large B-cell lymphoma (DLBCL):
Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens
Chronic lymphocytic leukemia (CLL):
Previously untreated and previously treated CD20-positive CLL in combination with FC (fludarabine and cyclophosphamide)
Intravenous rituximab (Rituxan) may be considered medically necessary to treat patients with NHL for the following off-label indications:
Mantle cell lymphoma:
First-line therapy in combination with one of guideline-based chemotherapy regimens.
Maintenance therapy until progression or intolerance.
Burkitt lymphoma:
First-line therapy
Posttransplant lymphoproliferative disorders:
For patients who have had an inadequate response to reduction of immunosuppression or are not candidates for reduction of immunosuppression
Subcutaneous Rituximab
Subcutaneous rituximab (Rituxan) may be considered medically necessary to treat patients with non-Hodgkin lymphoma (NHL) for the following FDA labeled indications:
Subcutaneous rituximab (rituximab and hyaluronidase human) [Rituxan Hycela]) may be considered medically necessary to treat patients with NHL who have received at least one full dose of intravenous rituximab for the following FDA labeled indications:
Follicular lymphoma (FL):
Previously untreated FL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
Non-progressing (including stable disease) FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
Relapsed or refractory FL as a single agent.
Diffuse large B-cell lymphoma (DLBCL):
Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline based-chemotherapy regimens.
Chronic lymphocytic leukemia (CLL):
Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).
Ofatumumab
Intravenous ofatumumab (Arzerra) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:
Chronic lymphocytic leukemia (CLL):
In combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate
In combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL
For extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL
For the treatment of patients with CLL refractory to fludarabine and alemtuzumab
Ofatumumab (Arzerra) is considered investigational as maintenance therapy in patients with CLL.
Ofatumumab (Arzerra) is considered investigational for the treatment of malignancies other than CLL.
Obinutuzumab
Intravenous obinutuzumab (Gazyva) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:
Follicular lymphoma (FL):
In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV FL.
In combination with bendamustine followed by obinutuzumab monotherapy, for the treatment of patients with FL who relapsed after, or are refractory to, a rituximab-containing regimen.
Chronic lymphocytic leukemia (CLL):
In combination with chlorambucil, for the treatment of patients with previously untreated CLL.
Obinutuzumab (Gazyva) is considered investigational for relapsed or refractory CLL.
