Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Obinutuzumab (Gazyva) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indications
Chronic Lymphocytic Leukemia (CLL)
- Previously untreated CLL when obinutuzumab (Gazyva) is used in combination with chlorambucil; or
Follicular Lymphoma (FL)
- In individuals with FL who relapsed after, or are refractory to, a rituximab-containing regimen obinutuzumab (Gazyva), is used in combination with bendamustine followed by obinutuzumab (Gazyva) monotherapy; or
- In adults with previously untreated stage II bulky, III or IV FL when obinutuzumab (Gazyva), in combination with chemotherapy followed by obinutuzumab monotherapy in individuals achieving at least a partial remission; or
National Comprehensive Cancer Network (NCCN) Recommendations
Castleman's Disease
- For the treatment of Castleman’s disease when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, AIDS-Related B-Cell
- For the treatment of AIDS-related B-cell lymphomas when used as a substitute** for rituximab in individuals with intolerance (including those experiencing sever hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Burkitt
- For the treatment of Burkitt Lymphoma when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Diffuse Large B-Cell
- For the treatment of diffuse large B-Cell lymphoma when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Follicular (grade 1-2)
- FL (grade 1-2) first-line therapy for stage I, contiguous stage II, non-contiguous stage II disease, or for individuals with indications for treatment with stage III or IV disease in combination with:
- CHOP (cyclophosphamide doxorubicin, vincristine, and prednisone) regimen (preferred); or
- CVP (cyclophosphamide, vincristine, and prednisone) regimen (***preferred); or
- Bendamustine (***preferred); or
- In combination with lenalidomide; or
- FL (grade 1-2) second-line or subsequent therapy (if not previously given as first-line) for refractory or progressive disease in individuals for treatment:
- Preferred*** in combination with bendamustine, CHOP (cyclophosphamide doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) regimen; or
- As a single agent or in combination with lenalidomide; or
- FL (grade 1-2) single-agent maintenance therapy:
- Preferred*** as optional single-agent first-line consolidation or extended dosing following chemoimmunotherapy; or
- Preferred*** as optional second-line consolidation or extended dosing for rituximab-refractory disease; or
- Can be considered for individuals with histologic transformation to diffuse large B-cell lymphoma that is coexisting with extensive Follicular lymphoma who achieve complete response to chemoimmunotherapy; or
- FL (grade 1-2) used as a substitute**for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Gastric Mucosa-associated Lymphoid Tissue (MALT)
- For the treatment of gastric MALT lymphoma when used as a second-line and subsequent therapy for relapsed or progressive disease in individuals with indications for treatment:
- Preferred*** in combination with bendamustine (not recommended if previously treated with bendamustine); or
- As a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen; or
- As a component of CVP (cyclophosphamide, vincristine, and prednisone with obinutuzumab regimen); or
- In combination with lenalidomide; or
- For treatment of gastric MALT lymphoma when used as preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab-refractory individuals treated with obinutuzumab and bendamustine regimen for recurrent disease; or
- For treatment of gastric MALT lymphoma when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, High Grade B-Cell
- For the treatment of high grade b-cell lymphomas when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell
- For the treatment of histologic transformation of nodal marginal zone lymphoma to diffuse large b-cell lymphoma when use as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Mantle Cell
- For the treatment of mantle cell lymphoma when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis; or
Lymphoma, Nodal Marginal Zone
- For the treatment of Nodal Marginal Zone Lymphoma when used as first-line therapy for stage I, contiguous stage II, non-contiguous stage II, or stage III, IV disease in individuals with indications for treatment:
- In combination with bendamustine (preferred***); or
- As a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen; or
- As a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen; or
- For the treatment of nodal marginal zone lymphoma as second-line or subsequent therapy for refractory or progressive disease in individuals with indications for treatment:
- Preferred *** in combination with bendamustine (not recommended if previously treated with bendamustine); or
- As a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen; or
- As a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen; or
- In combination with lenalidomide; or
- For the treatment of nodal marginal zone lymphoma as preferred ***maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab (Gazyva) and bendamustine regimen for recurrent disease; or
- For the treatment of nodal marginal zone lymphoma as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis and toxic epidermal necrolysis; or
Lymphoma, Nongastric MALT (Noncutaneous)
- For the treatment of nongastric MALT lymphoma (noncutaneous) when used as second-line and subsequent therapy for recurrent or progressive disease in individuals with indications for treatment:
- Preferred*** in combination with bendamustine (not recommended if previously treated with bendamustine); or
- As a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen; or
- As a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen; or
- In combination with lenalidomide; or
- For treatment of nongastric MALT lymphoma (noncutaneous) when used as preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab (Gazyva) and bendamustine regimen for recurrent disease; or
- For treatment of nongastric MALT lymphoma (noncutaneous) as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis and toxic epidermal necrolysis; or
Lymphoma, Small Lymphocytic (SLL) and CLL
- For the treatment of CLL/SLL without del(17p)/TP53 mutation when used as a first-line therapy in individuals aged 65 years or older and younger individuals with significant comorbidities (creatinine clearance [CrCl] <70mL/min] who have indications for treatment when used:
- In combination with acalabrutinib (preferred***); or
- In combination with venetoclax (preferred***); or
- In combination with ibrutinib or with chlorambucil; or
- In combination with high-dose methylprednisolone (HDMP); or
- As a single agent; or
- For treatment of CLL/SLL without del (17p)/TP53 mutation when used as first line therapy in combination with bendamustine for individuals aged 65 or older and younger individuals with or without significant comorbidities who have indications for treatment (not recommended for frail individuals; or
- For treatment of CLL/SLL without del (17p)/TP53 mutation when used as first-line therapy in combination with bendamustine for individuals aged 65 years or older and younger individuals with or without significant comorbidities who have indications for treatment (not recommended for frail individuals); or
- For treatment of CLL/SLL without del(17p)/TP53 mutation when used as first line therapy in individuals younger than 65 years of age without significant comorbidities who have indications for treatment:
- In combination with acalabrutinib or venetoclax (both preferred***); or
- In combination with high-dose methylprednisolone (HDMP); or
- For treatment of CLL/SLL without del(17p)/TP53 when used as a second-line and subsequent therapy in individuals who have indications for retreatment as a single agent or in combination with high-dose methylprednisolone (HDMP); or
- When used as a first-line therapy for CLL/SLL with del(17p)/TP53 in individuals with indications for treatment:
- In combination with acalabrutinib (preferred***); or
- In combination with venetoclax (preferred***); or
- As a single agent; or
Lymphoma, Splenic Marginal Zone
- For the treatment of splenic marginal zone lymphoma when used as second-line therapy for disease recurrence following initial management of splenomegaly (if previously treated with rituximab) and subsequent therapy in individuals with indications for treatment:
- Preferred*** in combination with bendamustine (not recommended if previously treated with bendamustine; or
- Used as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen; or
- Used as a component of CVP (cyclophosphamide, vincristine and prednisone) with obinutuzumab regimen; or
- Used in combination with lenalidomide; or
- For the treatment of splenic marginal zone lymphoma when used as preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab (Gazyva) and bendamustine regimen for recurrent disease; or
- For the treatment of splenic marginal zone lymphoma when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis and toxic epidermal necrolysis; or
Lymphoproliferative Disorders, Post-Transplant
- For the treatment of post-transplant lymphoproliferative disorders when used as a substitute** for rituximab in individuals with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis.
Obinutuzumab (Gazyva) is considered experimental/investigational for all other indications and therefore non-covered. Scientific evidence does not support its use for any other indications.
Procedure Codes
