Obinutuzumab (Gazyva) (ARCHIVED)

Policy ID: I-137-011

Section: Injections

Effective Date: August 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-137-011

Section: Injections

Effective Date: August 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

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

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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:

Chronic Lymphocytic Leukemia (CLL)

In individuals with previously untreated CLL used in combination with chlorambucil; or

Follicular Lymphoma (FL)

In individuals with FL who relapsed after, or are refractory to, a rituximab-containing regimen, and 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 used in combination with chemotherapy followed by obinutuzumab monotherapy in individuals achieving at least a partial remission; or

Compendia Sources

Obinutuzumab (Gazyva) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of Obinutuzumab (Gazyva) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9301

NOTE:United States Food and Drug Administration (U.S. FDA)-approved

* 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

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9301

B10.89

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

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

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

C91.40

C91.42

D47.Z1

D47.Z2

Diagnosis Code B20 covered when billed with ANY ONE of the following diagnosis codes

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.80

C83.81

C83.82

C83.83

C83.84

C83.85

C83.86

C83.87

C83.88

C83.89

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 1-20-2022

Updated NCCN recommendations

Internal Medical Policy Committee 3-23-2022 z

Removed NCCN recommendations; and
Added this statement 'Obinutuzumab (Gazyva) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'; and
Updated experimental/investigational statement.

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Added diagnosis codes C91.40 and C91.42
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Separated diagnosis code B20 into its own section in the diagnosis codes section

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived 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.

Medical Policies Quick Search

Obinutuzumab (Gazyva) (ARCHIVED)

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Description

Policy Application

Criteria

Procedure Code

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9301

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**