Obinutuzumab (Gazyva)

Policy ID: I-137-006

Section: Injections

Effective Date: August 01, 2020

Last Reviewed: July 22, 2020

Description

Obinutuzumab (Gazyva®) is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes.

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

J9301

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

* Obinutuzumab is preferred in rituximab refractory individuals, which includes individuals progressing on or within six (6) months of prior rituximab therapy

**Re-challenge with the same anti-CD20 monoclonal antibody is not recommended and it is unclear if the use of an alternative anti-CD20 monoclonal antibody poses the same risk of recurrence

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

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9301

B20	C82.00	C82.01	C82.02	C82.03	C82.04	C82.05
C82.06	C82.07	C82.08	C82.09	C82.10	C82.11	C82.12
C82.13	C82.14	C82.15	C82.16	C82.17	C82.18	C82.19
C82.20	C82.21	C82.22	C82.23	C82.24	C82.25	C82.26
C82.27	C82.28	C82.29	C82.30	C82.31	C82.32	C82.33
C82.34	C82.35	C82.36	C82.37	C82.38	C82.39	C82.40
C82.41	C82.42	C82.43	C82.44	C82.45	C82.46	C82.47
C82.48	C82.49	C82.50	C82.51	C82.52	C82.53	C82.54
C82.55	C82.56	C82.57	C82.58	C82.59	C82.60	C82.61
C82.62	C82.63	C82.64	C82.65	C82.66	C82.67	C82.68
C82.69	C82.80	C82.81	C82.82	C82.83	C82.84	C82.85
C82.86	C82.87	C82.88	C82.89	C82.90	C82.91	C82.92
C82.93	C82.94	C82.95	C82.96	C82.97	C82.98	C82.99
C83.00	C83.01	C83.02	C83.03	C83.04	C83.05	C83.06
C83.07	C83.08	C83.09	C83.10	C83.11	C83.12	C83.13
C83.14	C83.15	C83.16	C83.17	C83.18	C83.19	C83.30
C83.31	C83.32	C83.33	C83.34	C83.35	C83.36	C83.37
C83.38	C83.39	C83.70	C83.71	C83.72	C83.73	C83.74
C83.75	C83.76	C83.77	C83.78	C83.79	C83.80	C83.81
C83.82	C83.83	C83.84	C83.85	C83.86	C83.87	C83.88
C83.89	C83.90	C83.91	C83.92	C83.93	C83.94	C83.95
C83.96	C83.97	C83.98	C83.99	C85.20	C85.21	C85.22
C85.23	C85.24	C85.25	C85.26	C85.27	C85.28	C85.29
C85.80	C85.81	C85.82	C85.83	C85.84	C85.85	C85.86
C85.87	C85.88	C85.89	C88.4	C91.10	C91.12	D36.0
D47.Z1	D47.Z2	R59.0	R59.1	R59.9	Z85.72

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2020 Adopted new policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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