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 experiencing 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 experiencing 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 experiencing 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 experiencing 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)
- Follicular lymphoma (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; or
- CVP (cyclophosphamide, vincristine, and prednisone) regimen (***preferred); or
- Bendamustine(***preferred); or
- In combination with lenalidomide; or
- Follicular lymphoma (grade 1-2) second-line or subsequent therapy (if not previously given as first-line) for refractory or progressive disease in individuals with indications 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
- Follicular lymphoma (grade 1-2) maintenance therapy
- As 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
- Follicular lymphoma (grade 1-2) used as a substitute**for rituximab in individuals 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:
- Preferred*** second-line or subsequent therapy for recurrent or progressive disease in combination with bendamustine (not recommended if previously treated with bendamustine) in individuals with indications for treatment; or
- Preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab and bendamustine regimen for recurrent disease; or
- A substitute** for rituximab in individuals experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobollous 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 experiencing 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 lymphona to diffuse large b-cell lymphoma when use as:
- A substitute** for rituximab in individuals experiencing 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 experiencing 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:
- Preferred*** second-line or subsequent therapy for recurrent or progressive disease in combination with bendamustine (not recommended if previously treated with bendamustine) in indiviudals with indications for treatment; or
- ***Preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab and bendamustine regimen for recurrent disease; or
- A substitute** for rituximab in individuals 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:
- Preferred*** second-line or subsequent therapy for refractory or progressive disease in combination with bendamustine (not recommended if previously treated with bendamustine) in individuals with indications for treatment; or
- Preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab and bendamustine regimen for recurrent disease; or
- A substitute** for rituximab in individuals 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 combination with acalabrutinib in individuals with indications for treatment (preferred***); or
- In combination with venetoclax in individuals with indications for treatment (preferred***); or
- In combination with ibrutinib or with chlorambucil in frail individuals with significant comorbidity (not able to tolerate purine analogs) or age greater than or equal to 65 years and younger individuals with significant comorbidities (CrCl <70 ml/min); or
- In combination with bendamustine in individuals age greater than or equal to 65 years or for younger individualswith or without significant comorbidities who have indications for treatment (not recommended for frail individuals): or
- As a single agent in individuals age greater than or equal to 65 years, younger individuals with significant comorbidities(CrCl <70 ml/min) , or frail individuals with significant comorbidity unable to tolerate purine analogs; 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
- CLL/SLL single agent therapy for relapsed or refractory disease without del (17p)/TP53 mutation in individuals with indications for treatment;or
Lymphoma, Splenic Marginal Zone
For the treatment of splenic marginal zone lymphoma when used as:
- Preferred*** therapy in combination with bendamustine for disease recurrence following initial management of splenomegaly as second-line therapy (if previously treated with rituximab) or as subsequent therapy (not recommended if previously treated with bendamustine) in individuals with indications for treatment; or
- Preferred*** maintenance therapy as second-line consolidation or extended dosing in rituximab refractory individuals treated with obinutuzumab and bendamustine regimen for recurrent disease; or
- A substitute** for rituximab in individuals experiencing 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 experiencing 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